Clinical trial NCT03904550
Conditions: Neuromuscular Blockade Renal Impairment
Sponsor: University of Texas Southwestern Medical Center
Start date: 2019-12-10; Completion date: 2023-07-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is intended to be a single-site, prospective, randomized, double-blinded study that intends to enroll a total of 60 patients with severe renal impairment undergoing surgery with general endotracheal anesthesia at Parkland Hospital. Patients will be randomized to receive either neostigmine (for reversal of cisatracurium) or sugammadex (for reversal of rocuronium). A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care. All patients will be monitored with continuous pulse oximetry postoperatively for 24 hours.

Detailed description:
This will be a prospective, randomized, double-blinded study of surgical patients with severe renal impairment that seeks to address the following:

Specific Aim:

To determine whether rocuronium-induced moderate neuromuscular blockade and reversal with sugammadex achieves recovery of neuromuscular function (TOF ≥ 0.9) faster than reversal of cisatracurium-induced moderate neuromuscular blockade and reversal with neostigmine in patients with severe renal impairment.

Primary Hypothesis:

Patients with severe renal impairment who are reversed with sugammadex after rocuronium will achieve a TOF ≥0.9 within a time frame that is one-third of the time it takes for reversal with neostigmine after cisatracurium.

Arms: arm 1: Patients in the cisatracurium/neostigmine group will receive 0.2 mg/kg of cisatracurium for neuromuscular paralysis during induction. Additional cisatracurium will be given to keep the patient at a neuromuscular depth of 1 twitch throughout the surgery until the last 30 minutes, during which the patient will be kept at 2 twitches. arm 2: Patients in the rocuronium/sugammadex group will receive 0.6 mg/kg of rocuronium for neuromuscular paralysis during induction. Additional rocuronium will be given to keep the patient at a neuromuscular depth of 1 twitch throughout the surgery until the last 30 minutes, during which the patient will be kept at 2 twitches.
Interventions: intervention 1: Cisatracurium + Neostigmine intervention 2: Rocuronium + Sugammadex
Intervention descriptions: intervention 1: Maintenance neuromuscular blockade with boluses of cisatracurium to keep train-of-four (TOF) 1-2 twitches. For reversal, neostigmine with glycopyrrolate intervention 2: Maintenance neuromuscular blockade with boluses of rocuronium to keep TOF 1-2 twitches. For reversal, sugammadex

Protocol documents:
Prot_SAP_000.pdf: 
STU2018-0411, Moon, Form A3, Mod_7, 08-05-19 
 
 
 
Page 1 of 21 
 
 
 
 
Reversal of Neuromuscular Blockade in Patients with Severe Renal Impairment  
 
Principal Investigator:  Tiffany Sun Moon, MD 
 
 
 
 
Version 1.5 7/17/2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Page 2 of 21 
The University of Texas Southwestern Medical Center 
Institutional Review Board 
 
PROJECT SUMMARY 
 
 
Introduction and Purpose: 
Inadequate reversal of neuromuscular blockade is a common problem and contributes to 
postoperative respiratory complications including hypoventilation, hypoxia, reintubation, and a 
prolonged hospital stay [1-5].  Neostigmine has been the mainstay for reversal of neuromuscular 
blockade, but has a multitude of side effects such as bronchospasm, nausea/vomiting, hypotension, 
and bradycardia [6].  Sugammadex is a novel agent for reversal of neuromuscular paralysis induced 
by steroidal neuromuscular blocking drugs and belongs to a new category of drugs known as 
‘selective relaxant binding agents.’  Sugammadex selectively binds rocuronium in a 1:1 fashion and 
can reverse any depth of neuromuscular blockade and has been used in patients with severe renal 
impairment [7][8-11].   
 
Use of sugammadex has been proven to be safe in patients with a history of severe renal impairment 
[8-11].  The current standard of care for these patients is to use cisatracurium, which undergoes 
Hofmann elimination, which is independent of renal function.  Antagonism of neuromuscular blockade 
is then subsequently achieved with neostigmine.  Currently, there are no specific studies in patients 
with severe renal impairment evaluating the return of neuromuscular function after reversal of 
cisatracurium with neostigmine versus reversal of rocuronium with sugammadex.  Patients with 
severe renal impairment often have other comorbidities and are at high risk for postoperative cardiac 
and pulmonary complications.  Additionally, the simultaneous evaluation of clinical outcomes and 
quality of postoperative recovery has not been undertaken. 
 
The duration of rocuronium in patients with severe renal impairment is prolonged and can be 
unpredictable.  Therefore, cisatracurium is the preferred agent for neuromuscular blockade in patients 
with severe renal impairment since it undergoes Hofmann elimination, which is independent of renal 
function.  Neuromuscular blockade has also been achieved with rocuronium and successful reversed 
with sugammadex, even in patients with severe renal impairment.  Dialysis through a high-flux filter 
effectively removes sugammadex and the sugammadex-rocuronium compound from the circulation 
[26]. 
 
There has been anecdotal evidence that patients treated with sugammadex have better subjective 
measures of recovery compared to patients treated with neostigmine.  However, very few studies 
have systematically evaluated this.  Some authors have shown that patients treated with 
sugammadex have less postoperative nausea and vomiting or pain compared to patients treated with 
cholinesterase inhibitors [27, 28].  Amorim et al. showed that in an observational study of 101 
patients, those treated with sugammadex had improved psychological and nociceptive postoperative 
recovery and higher overall satisfaction compared to those treated with neostigmine [29].  As patient-
reported outcomes have become increasingly important for hospitals, treatments that have the 
potential to increase patient satisfaction are being studied closely [30].  The postoperative quality 
recovery scale (PQRS) is a tool that assesses recovery in terms of different domains over time and 
compares them to baseline values [31].  Some of the advantages of the PQRS are that it is validated, 
takes less than 5 minutes to administer, has a low patient refusal rate, and is acceptable to patients 
across a wide range of ages [34].  
 
This will be a prospective, randomized, double-blinded study of surgical patients with severe 
renal impairment that seeks to address the following: 
 
Specific Aim 1: 
To determine whether rocuronium-induced moderate neuromuscular blockade and reversal with 
sugammadex achieves recovery of neuromuscular function (TOF ≥ 0.9) faster than reversal of 


STU2018-0411, Moon, Form A3, Mod_7, 08-05-19 
 
 
 
Page 3 of 21 
cisatracurium-induced moderate neuromuscular blockade and reversal with neostigmine in patients 
with severe renal impairment. 
 
Primary Hypothesis:  
Patients with severe renal impairment who are reversed with sugammadex after rocuronium will 
achieve a TOF ≥0.9 within a time frame that is one-third of the time it takes for reversal with 
neostigmine after cisatracurium.   
 
Specific Aim 2:   
To determine if reversal with sugammadex versus neostigmine results in improved postoperative 
recovery, as measured by the postoperative quality recovery scale (PQRS) and QoR score. 
  
Secondary Hypothesis:   
Patients reversed with sugammadex (versus neostigmine) will have a higher quality of recovery in the 
postoperative period. 
 
Background: 
The incidence of residual postoperative neuromuscular blockade has been reported to be 30-60%, as 
defined by a train of four ratio (TOFR) <0.9 [1, 22-25].  Critical respiratory events (e.g., severe 
hypoxemia, upper airway obstruction, reintubation, aspiration) are significantly increased with TOFR 
<0.9 on admission to the PACU [1, 25].  Patients with severe renal impairment often have major 
comorbidities with little tolerance for postoperative residual neuromuscular blockade.  Neostigmine 
takes much longer to achieve full reversal from neuromuscular paralysis than sugammadex [7, 12-15].   
 
Sugammadex is a modified gamma cyclodextrin that forms a complex with the steroidal 
neuromuscular blocking agents rocuronium and vecuronium.  This complex is then renally excreted, 
which reduces the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic 
receptors in the neuromuscular junction. Therefore, the administration of sugammadex results in the 
rapid reversal of neuromuscular blockade induced by rocuronium and vecuronium.  Neostigmine has 
been the mainstay for reversal of neuromuscular blockade but is associated with adverse side effects 
such as nausea/vomiting, abdominal pain, and increased secretions.  Neostigmine also takes much 
longer to achieve full reversal from neuromuscular paralysis than sugammadex [7-11].  Furthermore, 
unwarranted administration of neostigmine can actually result in worsening of neuromuscular 
paralysis [24-29].   
 
Concise Summary of Project: 
This study is intended to be a single-site, prospective, randomized, double-blinded study that intends 
to enroll a total of 60 patients with severe renal impairment undergoing surgery with general 
endotracheal anesthesia at Parkland Hospital. Patients will be randomized to receive either 
neostigmine (for reversal of cisatracurium) or sugammadex (for reversal of rocuronium). A 
standardized anesthetic protocol that is usual and customary for the type of operation the patient is 
having will be provided to the anesthesia teams of enrolled subjects.  The remainder of the anesthetic 
care of the subject will not deviate from the standard of care.  All patients will be monitored with 
continuous pulse oximetry postoperatively for 24 hours. 
 
Study Procedures: 
Screening and Informed Consent 
A member of the research team will use a screening form to look for surgical patients that meet all of 
the inclusion and exclusion criteria. Patients will be informed that they will receive no compensation 
for participating in the study and there will be no adverse consequences if they choose not to 
participate. If the subjects agree to participate, informed written consent will be obtained prior to any 
study procedures and this document will be sent to pmhresearchparticipants@phhs.org, for inclusion 
in the patient’s medical record, per Parkland regulations. The study duration is approximately 30 days, 
from the start of anesthesia until POD 30. 


STU2018-0411, Moon, Form A3, Mod_7, 08-05-19 
 
 
 
Page 4 of 21 
 
Baseline Subjective Measures 
In the preoperative area, patients will be asked to complete the baseline assessment for the 
postoperative quality recovery scale (Appendix 1) and demographic information will be gathered. 
 
Anesthesia Protocol (Appendix 2) 
The anesthesia team that will be caring for the patient during surgery will be given the protocol for the 
study, which standardizes the general anesthetic technique.  Patients in the rocuronium/sugammadex 
group will receive 0.6 mg/kg of rocuronium for neuromuscular paralysis during induction.  Additional 
rocuronium will be given in 0.15 mg/kg increments to keep the patient at a neuromuscular depth of 1 
twitch throughout the surgery until the last 30 minutes, during which the patient will be kept at 2 
twitches.  Patients in the cisatracurium/neostigmine group will receive 0.2 mg/kg of cisatracurium for 
neuromuscular paralysis during induction.  Additional cisatracurium will be given in 0.03 mg/kg 
increments to keep the patient at a neuromuscular depth of 1 twitch throughout the surgery until the 
last 30 minutes, during which the patient will be kept at 2 twitches.  All patients will have the depth of 
neuromuscular block monitored at the adductor pollicis with a TwitchView electromyography-based 
device (Blink, Seattle, WA) that provides real time feedback of the strength of contraction and 
graphically displays the relevant ratios.  All assessments of depth of neuromuscular blockade will be 
recorded into the patient’s electronic medical record.  
 
Maintenance of anesthesia will be with sevoflurane in 50% oxygen, titrated to keep the bispectral 
index (BIS) between 40-60.  All patients will have a forced air warming device (e.g., Bair Hugger, 3M, 
Maplewood, MN) used to maintain normothermia throughout the surgery.  Subjects will be 
randomized to receive all blinded study drugs: either neostigmine for reversal of cisatracurium or 
sugammadex for reversal of rocuronium.  The reversal agent will be administered intravenously at the 
beginning of skin closure when the patient has moderate neuromuscular blockade (i.e., TOF = 2 
twitches).  The anesthesia team will be completely blinded and the postoperative assessments will 
also be completed by a separate blinded member of the research team.  The induction neuromuscular 
blocking agent syringe will be drawn up by pharmacy and contain either cisatracurium 0.2 mg/kg or 
rocuronium 0.6 mg/kg and filled with normal saline to make identical 10mL syringes. If the patient is ≥ 
100 kg, a 20mL syringe will be used (instead of 10mL).  The maintenance neuromuscular blocking 
agent syringe will be drawn up by pharmacy and contain 5 or 10mL of either rocuronium (10 mg/mL) 
or cisatracurium (2 mg/mL) [both in their original, undiluted concentrations].  The reversal agent will 
also be drawn up by pharmacy and will contain neostigmine 50 mcg/kg mixed (maximum 5mg) with 
glycopyrrolate 10 mcg/kg (maximum 1mg) or sugammadex 2 mg/kg.  The blinded study drug 
(“reversal agent”) will be prepared into a 10 mL syringe by a pharmacist in Investigational Drug 
Service (IDS) Pharmacy and labeled as “sugammadex or neostigmine/glycopyrrolate.”  Any volume of 
blinded study drug that is less than 10 mL will be supplemented with 0.9% normal saline solution so 
that all syringes contain a volume of 10 mL and appear identical in order to preserve blinding. The 
remaining aspects of the anesthetic will be standardized and not differ from the standard of care for all 
patients.   
 
Randomization & Dosing: 
Patients will be randomized to one of two groups for neuromuscular blockade and reversal of 
neuromuscular paralysis: 
1. Group 1- cisatracurium + neostigmine (NEO group) 
a. Induction neuromuscular blockade with 0.2 mg/kg cisatracurium 
b. Maintenance neuromuscular blockade with boluses of 0.03 mg/kg cisatracurium to 
keep TOF 1-2 twitches 
c. Reversal: neostigmine 50 mcg/kg, maximum 5 mg mixed with glycopyrrolate, 10 
mcg/kg, maximum 1 mg 
 
2. Group 2- rocuronium + sugammadex (SUG group) 
a. Induction neuromuscular blockade with 0.6 mg/kg rocuronium 
b. Maintenance neuromuscular blockade with boluses of 0.15 mg/kg rocuronium to keep 


STU2018-0411, Moon, Form A3, Mod_7, 08-05-19 
 
 
 
Page 5 of 21 
TOF 1-2 twitches 
c. Reversal: Sugammadex 2 mg/kg 
 
The statistician will make randomization envelopes by using a random number generator.  These 
envelopes will be provided to Investigational Drug Services (IDS) Pharmacy before any subjects are 
screened and later only as needed to replenish supply. The words ‘cisatracurium + 
neostigmine/glycopyrrolate’ or ‘rocuronium + sugammadex’ will be printed on a piece of paper and 
placed in an opaque manila envelope that bears a unique subject number.  Upon receiving the 
physician order for the subject, the IDS Pharmacist will randomize the subject to a treatment group by 
opening the randomization envelope bearing the subject number corresponding to the subject number 
written on the physician order.  
 
The Investigator or Co-Investigator will write the patient’s weight on the order form so that the 
pharmacist can perform necessary dose calculations and draw up the appropriate intravenous dose of 
the blinded study drugs. After the blinded study drug syringes are prepared, a pharmacist or 
pharmacy technician will deliver the syringe to the operating room to the anesthesia provider, who will 
sign for receipt of study drug syringe. 
 
Blinding/Un-blinding: 
The patient, all medical providers (surgeons, anesthesia faculty, anesthesia residents, certified 
registered nurse anesthetists, nurses), and the postoperative evaluator will be blinded as to what 
neuromuscular blocking drug and reversal agent the patient receives.  A member of the research 
team that is not involved in the direct care or assessment of the patient will provide the randomization 
envelopes to IDS Pharmacy. IDS Pharmacy staff will be the only un-blinded personnel.  
 
In emergency scenarios when un-blinding becomes necessary (e.g., anaphylaxis), the principal 
investigator or co-investigators may call the IDS Pharmacy to ascertain which specific medication(s) 
was dispensed.  A detailed log of patient enrollments, randomization assignments and drug 
accountability will be kept in Investigational Drug Service (IDS) Pharmacy, which has controlled 
security access.  
 
Calculation of Key Times 
The time that the reversal agent (sugammadex versus neostigmine) is given will be marked as 
‘Reversal Time’, and times to last stitch, extubation, and out of OR will be ascertained from the 
electronic medical record (EMR) (i.e., Epic Systems, Verona, WI).  Once the patient arrives in the 
PACU, a trained research assistant will assess the degree of neuromuscular function the patient has 
using the TwitchView set to 30mA.  Adequate reversal will be defined as a train of four ratio (TOFR)  
0.9.  Anything less than 0.9 will be defined as residual paralysis or inadequate reversal.  
 
PACU Assessment 
A blinded, trained research assistant will observe and record all parameters from the time the patient 
arrives in the PACU until they are discharged from the PACU.  All episodes of hypoxia and any use of 
supplemental oxygen will be recorded.  All vital signs will be extracted from the EMR.  Any drugs 
given in the PACU will be recorded.  At 15 minutes (T15), 40 minutes (T40), and 80 minutes (T80) after 
arrival to the PACU, the patient will be assessed using the postoperative quality recovery scale 
(PQRS) in 3 domains (Appendix 1). 
 
Postoperative Day (POD) 1 Assessments 
All patients will be admitted to the hospital for continuous SpO2 monitoring for 24 hours.  Patients who 
are on dialysis will resume their normal dialysis schedule, which will be recorded.  On POD 1 the 
patient will be assessed using the postoperative quality of recovery scale (PQRS) in 5 domains 
(Appendix 3).  Patients who are still in the hospital on POD 2 will be assessed using the PQRS as 
well.  Patients who are discharged home will be called on the telephone and the PQRS will be 
assessed in 4 domains (no physiological assessments).  All patients will be followed for their total 
hospital length of stay and assessed for any major adverse events (reintubation, pneumonia, 


STU2018-0411, Moon, Form A3, Mod_7, 08-05-19 
 
 
 
Page 6 of 21 
myocardial infarction, stroke, unplanned hospital admission, or readmission within 30 days of hospital 
discharge).   
 
 
Data Sources 
Protected health information including name, medical record number, and date of birth will be 
recorded and stored securely in an IRB approved, secured REDCap database. 
  
Parameters: 
1. Protected health information (PHI):  name, medical record number, date of birth, phone number 
2. Demographic information (age, weight, height, BMI), medical and surgical history, ASA status  
3. Preoperative PQRS assessment 
4. Intraoperative parameters  
• 
Frequency and dose of all neuromuscular blocking and reversal agents 
• 
Intraoperative vitals (systolic, diastolic, and mean blood pressures, temperature, heart rate) at 
least every 3 minutes 
• 
ECG rhythm 
• 
Fluids administered 
• 
End-tidal concentration of anesthetic (e.g., sevoflurane) 
• 
Total intraoperative opioids 
• 
Length of surgery 
• 
The time from last neuromuscular blocking agent given to reversal agent (min) 
• 
The time from neuromuscular reversal to last stitch (min) 
• 
The time from neuromuscular reversal to extubation (min) 
• 
The time from neuromuscular reversal to discharge from the OR (min) 
• 
The time from surgery completed (bandage on) to discharge from the OR (min) 
• 
Depth of neuromuscular blockade throughout the surgery at 15-minute intervals 
• 
Presence of hemodynamic changes, rash, erythema, or flushing after reversal agent given 
5. PACU parameters 
• 
Evaluation of residual paralysis with train of four (TOF) stimulation using the TwitchView within 
5 minutes of PACU arrival and every 5 minutes until a TOF  0.9 is reached 
• 
Time it takes to achieve TOFR  0.9 
• 
Vitals during PACU stay (BP, temperature, HR, SpO2) every 10 minutes 
• 
Number of hypoxic episodes (SpO2<95%) 
• 
Lowest observed SpO2 during any episode of airway obstruction 
• 
Need for supplemental oxygen  
• 
Any episodes of airway obstruction and treatment (e.g., jaw thrust, insertion of 
nasopharyngeal, oropharyngeal or laryngeal mask airway or reintubation). 
• 
The time when PACU discharge criteria are met 
• 
Total PACU time (PACU arrival to actual discharge from PACU) 
• 
PQRS in 3 domains (Appendix 1) at 15 minutes, 40 minutes and 80 minutes 
6. Postoperative day 1-2 evaluation  
• 
PQRS in 4-5 domains (Appendix 3) 
8.  Adverse event monitoring (until POD 30) 
• 
Reintubation 
• 
Recurarization  
• 
Critical respiratory adverse event including bronchospasm, atelectasis, pulmonary edema 
• 
Cardiovascular adverse events such as tachycardia, bradycardia, cardiac arrhythmias, 
hypotension, and hypertension 
• 
Major adverse postoperative events (pneumonia, reintubation, myocardial infarction, stroke) 
• 
Unplanned hospital admission 
 
Criteria for Inclusion of Subjects: 


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Page 7 of 21 
• 
18-80 years old 
• 
Severe renal impairment (CrCl < 30 mL/min) 
• 
Undergoing non-emergent surgery that requires neuromuscular blockade 
• 
Planned extubation in the operating room immediately after surgery 
• 
ASA physical status classification 3 to 4 
• 
Willing and able to consent in English or Spanish 
• 
No personal history of neuromuscular disease 
 
Criteria for Exclusion of Subjects: 
• 
Age less than 18 or older than 80 
• 
Patient does not speak English or Spanish 
• 
Morbidly obese (BMI> 40-49.9 kg/m2) 
• 
Planned postoperative intubation/ventilation 
• 
Allergy to sugammadex, neostigmine, glycopyrrolate, cisatracurium, or rocuronium 
• 
Family or personal history of malignant hyperthermia 
• 
Patient refusal 
• 
“Stat” (emergent) cases 
• 
Patients undergoing thoracic operations (e.g., video assisted thoracoscopic surgery, 
thoracotomy) 
• 
Pre-existing muscle weakness of any etiology 
• 
Patients with moderate to severe COPD 
• 
Patients with sleep apnea  
• 
Patients on toremifene (a selective estrogen receptor modulator) 
• 
Women of childbearing age who: 
a. Have a positive pregnancy test 
b. Are on oral contraceptives and not willing to use a non-hormonal method of contraception 
for 7 days after surgery  
            c. Nursing women 
 
 
Sources of Research Material: 
• 
Identifying patient information including name, medical record number, and birth date 
• 
Medical history  
• 
Surgical history 
• 
Weight and height 
• 
Medication list 
• 
Laboratory studies 
• 
Vital signs 
• 
ECGs and radiologic studies 
• 
Intraoperative anesthetic record 
• 
Postoperative notes and discharge summary 
 
Recruitment Methods and Consenting Process: 
Subjects who meet all inclusion and exclusion criteria will be approached by a member of the 
research team either in the pre-anesthesia evaluation clinic or in the preoperative area of day surgery 
in a private room or in their private room on the floor if they are an inpatient.  All study procedures will 
be explained to the patient in layman’s terms.  If the subject agrees to participate, he or she (or their 
legal representative) will sign the consent form and HIPAA Authorization Form prior to any study 
procedures.  
 
Potential Risks: 
The additional risks posed by participation in this study are not different than the usual risks 
associated with surgery and general anesthesia.  There is a potential for a direct benefit to the patient 


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Page 8 of 21 
if they receive sugammadex, based on available literature, which reports that sugammadex is superior 
to neostigmine for reversal of neuromuscular blockade [7-17].  The anesthetic management of 
subjects will not differ from the standard care.  Patients will be randomized to receive either 
neostigmine or sugammadex for reversal of neuromuscular paralysis.  
 
Risk of Sugammadex: 
The most common adverse reactions after administration of sugammadex are nausea/vomiting, pain, 
hypotension, dizziness, itching, and headache. There is a 0.3% chance of an allergic reaction to 
sugammadex.  
 
Neuromuscular blockade recurrence could theoretically occur after the administration of sugammadex 
due to displacement of rocuronium from sugammadex by other drugs.This has not been reported in 
the literature.  The association rate of rocuronium with sugammadex is very high and the dissociation 
rate is very low, due to the intermolecular (van Der Waals’) forces and hydrophobic interactions.  It is 
estimated that for every 25 million sugammadex-rocuronium compounds, only 1 dissociates (Nag 
2013).    
 
The sugmmadex label has a warning for the use of the drug in patients with severe renal impairment. 
Sugammadex is “not recommended” for use in patients with severe renal impairment, including those 
requiring dialysis. The label states that sugammadex is known to be substantially excreted by the 
kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal 
function and the elderly because elderly patients are more likely to have decreased renal function. 
The half-life of sugammadex in patients with mild, moderate and severe renal impairment is 4, 6, and 
19 hours, respectively. 
 
Marked bradycardia can be seen, some of which have resulted in cardiac arrest, have been observed 
within minutes after the administration of sugammadex. This is not different for patients with vs 
without renal impairment. 
 
The sugammadex label states that it may bind to progesterone thereby decreasing exposure. 
Therefore, the administration of a bolus dose of sugammadex is considered to be equivalent to 
missing dose(s) of oral contraceptives containing an estrogen or progesterone. If an oral 
contraceptive is taken on the same day that sugammadex is administered, the patient must use an 
additional, non-hormonal contraceptive method or back-up method of contraception (such as 
condoms and spermicides) for the next 7 days.  Female subjects who are using oral contraceptives 
will be informed during the consenting process that they will need to use a non-hormonal method of 
contraception for 7 days if they participate in the study.  Women who do not wish to do this will not be 
enrolled in the study.  Women who do choose to participate will be provided a letter (in English or 
Spanish) with this information and phone number of the PI if they have any additional questions.   
 
Risks of Rocuronium  
The most common adverse reactions after administration of rocuronium are nausea, vomiting, light 
headedness, and minor changes in blood pressure. 
 
Risks of Cisatracurium  
The most common adverse reactions after administration of cisatracurium are nausea, vomiting, light 
headedness, and minor changes in blood pressure. 
 
Risks of Neostigmine 
The most common adverse reactions after administration of neostigmine are nausea, vomiting, and 
low heart rate, but another drug called glycopyrrolate is always given along with neostigmine to 
counteract the potential drop in heart rate. 
 
Risks of Glycopyrrolate 


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The most common adverse reactions after administration of glycopyrrolate are tachycardia, dry 
mouth, nausea/vomiting, and headache. A rare but serious complication of glycopyrrolate is a severe 
rise in body temperature and abnormal heart rhythm. 
 
Psychological Stress 
There is minimal risk for psychological stress to the patient as a result of participation in this study.  
Subjects may refuse to answer any of the questions or take a break or stop participation in the study 
at any time. 
 
Subject Safety and Data Monitoring: 
Study oversight will include a Data Safety and Monitoring Board (DSMB).  The DSMB will be chaired 
by a faculty member that is not the PI and will include specialists from different specialties including 
anesthesiology, critical care medicine, and nephrology.  The DSMB will meet quarterly as needed to 
review all patient enrollments.  If necessary, the DSMB will meet more often to review specific study 
subjects, unanticipated events, protocol violations, and adverse events.  All study subjects will be 
reviewed by the DSMB for any study-related adverse outcomes.  A written record of all meetings will 
be kept.  The IRB will be notified in writing of any adverse study-related outcomes. The PI will provide 
to the Parkland Office of Research Administration (ORA) safety progress reports after the first 3 
patients, then again at 10 patients and then with the annual continuing review.   
 
 
Procedures to Maintain Confidentiality: 
A non-identifiable code will be assigned to the data collection sheet so that there is not a direct link to 
specific names.  Patient IDs will be standardized in chronological order as subject 1, subject 2, etc. A 
key to the coding system will be maintained in a locked storage cabinet with limited access until all the 
data is collected and analyzed. Access to study data will be restricted to authorized study personnel 
only. Following the completion of the analysis and the project, the key to the coding system or subject 
identifiers themselves will be destroyed by shredding the documents so that there is no direct or 
indirect link to subject identifiers and information. 
 
All data from the study will be kept on encrypted computers belonging to the University, which are 
stored in secured areas. All electronic study data will be password protected and passwords will be 
changed on a regular basis. 
 
All data will be de-identified when exported from the REDCap database.  Patient data will be analyzed 
without patient identifiers by assigning study ID subject numbers that are de-linked from patient 
identifiers.  Signed consent forms, HIPAA forms, and study questionnaires will remain in a locked 
cabinet in the PI’s office. 
 
 
Potential Benefits: 
This study is not designed to directly benefit the study subjects who participate in this study, but there 
may be potential for a direct benefit to the patient if they receive sugammadex, based on available 
literature, which reports that sugammadex is superior to neostigmine for reversal of neuromuscular 
blockade [7-17].  This study is intended to evaluate if sugammadex provides superior reversal of 
neuromuscular blockade compared to neostigmine with regard to decreased hypoxia, increased 
operating room efficiency, and improved postoperative recovery quality.  
 
Statistics: 
The principal investigator will be responsible for analyzing the study data with a biostatistician.  For 
the final analysis, the database will not be unblinded until enrollment, medical review, protocol 
violations, and data have been collected. 
 
Specific Aim 1: 


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To determine whether rocuronium-induced moderate neuromuscular blockade and reversal with 
sugammadex achieves recovery of neuromuscular function (TOF ≥ 0.9) faster than reversal of 
cisatracurium-induced moderate neuromuscular blockade and reversal with neostigmine in patients 
with severe renal impairment. 
 
Primary Hypothesis:  
Patients with severe renal impairment who are reversed with sugammadex after rocuronium will 
achieve a TOF ≥0.9 within a time frame that is one-third of the time it takes for reversal with 
neostigmine after cisatracurium.   
 
Sample Size Justification: 
The sample size calculation is based on the assumption that the treatment group (SUG) will have a 10 
min faster time to mean recovery to TOF ≥0.9 compared to the control group (NEO) (assuming 5 
minutes reversal time for SUG group and 15 minutes for NEO group).  With 24 subjects in each 
group, this gives the study a power > 99% to detect a difference of at least 10 min in the mean time to 
recovery, assuming a SD of 1.5 min in the SUG group and a SD of 5.5 min in the NEO group. 
Accounting for dropouts, protocol deviations, or unexpected postoperative ventilation, etc. a maximum 
of 60 patients will be enrolled. 
 
Analysis Plan: 
In the primary analysis, we will compare the mean time to recovery to TOF≥0.9 by the two-sample t 
test, using a Satterthwaite correction to the degrees of freedom to account for an anticipated 
difference in the variances between the treatment arms.  Two key secondary outcomes are the 
numbers of hypoxic episodes in the recovery room and in the first 24 hours postoperatively. We will 
also analyze these data using two-sample t tests with the Satterthwaite correction.  For each type of 
adverse event, we will create a two-way table cross-classifying subjects by treatment arm and 
whether they experienced the adverse event.  We will conduct a Fisher exact test on each such table 
to determine whether there is a significant association between treatment arm and the event.  As 
these are safety analyses, we will not adjust for multiplicity. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


STU2018-0411, Moon, Form A3, Mod_7, 08-05-19 
 
 
 
Page 11 of 21 
References: 
1. 
Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS: Residual 
neuromuscular blockade and critical respiratory events in the postanesthesia care unit. 
Anesth Analg 2008, 107(1):130-137. 
2. 
Brull SJ, Murphy GS: Residual neuromuscular block: lessons unlearned. Part II: methods 
to reduce the risk of residual weakness. Anesth Analg 2010, 111(1):129-140. 
3. 
Plaud B, Debaene B, Donati F, Marty J: Residual paralysis after emergence from 
anesthesia. Anesthesiology 2010, 112(4):1013-1022. 
4. 
Thilen SR, Hansen BE, Ramaiah R, Kent CD, Treggiari MM, Bhananker SM: Intraoperative 
neuromuscular monitoring site and residual paralysis. Anesthesiology 2012, 117(5):964-
972. 
5. 
Kumar GV, Nair AP, Murthy HS, Jalaja KR, Ramachandra K, Parameshwara G: Residual 
neuromuscular blockade affects postoperative pulmonary function. Anesthesiology 
2012, 117(6):1234-1244. 
6. 
Pani N, Dongare PA, Mishra RK: Reversal agents in anaesthesia and critical care. Indian J 
Anaesth 2015, 59(10):664-669. 
7. 
Carron M, Zarantonello F, Tellaroli P, Ori C: Efficacy and safety of sugammadex compared 
to neostigmine for reversal of neuromuscular blockade: a meta-analysis of randomized 
controlled trials. J Clin Anesth 2016, 35:1-12. 
8. 
Staals LM, Snoeck MM, Driessen JJ, Flockton EA, Heeringa M, Hunter JM: Multicentre, 
parallel-group, comparative trial evaluating the efficacy and safety of sugammadex in 
patients with end-stage renal failure or normal renal function. Br J Anaesth 2008, 
101(4):492-497. 
9. 
Staals LM, Snoeck MM, Driessen JJ, van Hamersvelt HW,   EA, van den Heuvel MW, Hunter 
JM: Reduced clearance of rocuronium and sugammadex in patients with severe to end-
stage renal failure: a pharmacokinetic study. Br J Anaesth 2010, 104(1):31-39. 
10. 
de Souza CM, Tardelli MA, Tedesco H, Garcia NN, Caparros MP, Alvarez-Gomez JA, de 
Oliveira Junior IS: Efficacy and safety of sugammadex in the reversal of deep 
neuromuscular blockade induced by rocuronium in patients with end-stage renal 
disease: A comparative prospective clinical trial. Eur J Anaesthesiol 2015, 32(10):681-
686. 
11. 
Panhuizen IF, Gold SJ, Buerkle C, Snoeck MM, Harper NJ, Kaspers MJ, van den Heuvel MW, 
Hollmann MW: Efficacy, safety and pharmacokinetics of sugammadex 4 mg kg-1 for 
reversal of deep neuromuscular blockade in patients with severe renal impairment. Br J 
Anaesth 2015, 114(5):777-784. 
12. 
Jones RK, Caldwell JE, Brull SJ, Soto RG: Reversal of profound rocuronium-induced 
blockade with sugammadex: a randomized comparison with neostigmine. 
Anesthesiology 2008, 109(5):816-824. 
13. 
Geldner G, Niskanen M, Laurila P, Mizikov V, Hubler M, Beck G, Rietbergen H, Nicolayenko 
E: A randomised controlled trial comparing sugammadex and neostigmine at different 
depths of neuromuscular blockade in patients undergoing laparoscopic surgery. 
Anaesthesia 2012, 67(9):991-998. 
14. 
Blobner M, Eriksson LI, Scholz J, Motsch J, Della Rocca G, Prins ME: Reversal of 
rocuronium-induced neuromuscular blockade with sugammadex compared with 
neostigmine during sevoflurane anaesthesia: results of a randomised, controlled trial. 
Eur J Anaesthesiol 2010, 27(10):874-881. 
15. 
Schaller SJ, Fink H: Sugammadex as a reversal agent for neuromuscular block: an 
evidence-based review. Core Evid 2013, 8:57-67. 
16. 
Illman HL, Laurila P, Antila H, Meretoja OA, Alahuhta S, Olkkola KT: The duration of residual 
neuromuscular block after administration of neostigmine or sugammadex at two visible 
twitches during train-of-four monitoring. Anesth Analg 2011, 112(1):63-68. 
17. 
Khuenl-Brady KS, Wattwil M, Vanacker BF, Lora-Tamayo JI, Rietbergen H, Alvarez-Gomez 
JA: Sugammadex provides faster reversal of vecuronium-induced neuromuscular 
blockade compared with neostigmine: a multicenter, randomized, controlled trial. 
Anesth Analg 2010, 110(1):64-73. 


STU2018-0411, Moon, Form A3, Mod_7, 08-05-19 
 
 
 
Page 12 of 21 
18. 
Lemmens HJ, El-Orbany MI, Berry J, Morte JB, Jr., Martin G: Reversal of profound 
vecuronium-induced neuromuscular block under sevoflurane anesthesia: sugammadex 
versus neostigmine. BMC Anesthesiol 2010, 10:15. 
19. 
Della Rocca G, Pompei L, Pagan DEPC, Tesoro S, Mendola C, Boninsegni P, Tempia A, 
Manstretta S, Zamidei L, Gratarola A et al: Reversal of rocuronium induced neuromuscular 
block with sugammadex or neostigmine: a large observational study. Acta Anaesthesiol 
Scand 2013, 57(9):1138-1145. 
20. 
Woo T, Kim KS, Shim YH, Kim MK, Yoon SM, Lim YJ, Yang HS, Phiri P, Chon JY: 
Sugammadex versus neostigmine reversal of moderate rocuronium-induced 
neuromuscular blockade in Korean patients. Korean J Anesthesiol 2013, 65(6):501-507. 
21. 
Wu X, Oerding H, Liu J, Vanacker B, Yao S, Dahl V, Xiong L, Claudius C, Yue Y, Huang Y et 
al: Rocuronium blockade reversal with sugammadex vs. neostigmine: randomized 
study in Chinese and Caucasian subjects. BMC Anesthesiol 2014, 14:53. 
22. 
Murphy GS, Brull SJ: Residual neuromuscular block: lessons unlearned. Part I: 
definitions, incidence, and adverse physiologic effects of residual neuromuscular 
block. Anesth Analg 2010, 111(1):120-128. 
23. 
Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Vender JS, Parikh KN, Patel 
SS, Patel A: Residual Neuromuscular Block in the Elderly: Incidence and Clinical 
Implications. Anesthesiology 2015, 123(6):1322-1336. 
24. 
Baillard C, Clec'h C, Catineau J, Salhi F, Gehan G, Cupa M, Samama CM: Postoperative 
residual neuromuscular block: a survey of management. Br J Anaesth 2005, 95(5):622-
626. 
25. 
Martinez-Ubieto J, Ortega-Lucea S, Pascual-Bellosta A, Arazo-Iglesias I, Gil-Bona J, Jimenez-
Bernardo T, Munoz-Rodriguez L: Prospective study of residual neuromuscular block and 
postoperative respiratory complications in patients reversed with neostigmine versus 
sugammadex. Minerva Anestesiol 2016, 82(7):735-742. 
26. 
Cammu G, Van Vlem B, van den Heuvel M, Stet L, el Galta R, Eloot S, Demeyer I: 
Dialysability of sugammadex and its complex with rocuronium in intensive care 
patients with severe renal impairment. Br J Anaesth 2012, 109(3):382-390. 
27. 
Lee OH, Choi GJ, Kang H, Baek CW, Jung YH, Woo YC, Oh J, Park YH: Effects of 
sugammadex vs. pyridostigmine-glycopyrrolate on post-operative nausea and 
vomiting: propensity score matching. Acta Anaesthesiol Scand 2017, 61(1):39-45. 
28. 
Castro DS, Jr., Leao P, Borges S, Gomes L, Pacheco M, Figueiredo P: Sugammadex 
reduces postoperative pain after laparoscopic bariatric surgery: a randomized trial. 
Surg Laparosc Endosc Percutan Tech 2014, 24(5):420-423. 
29. 
Amorim P, Lagarto F, Gomes B, Esteves S, Bismarck J, Rodrigues N, Nogueira M: 
Neostigmine vs. sugammadex: observational cohort study comparing the quality of 
recovery using the Postoperative Quality Recovery Scale. Acta Anaesthesiol Scand 2014, 
58(9):1101-1110. 
30. 
Bluemel S, Menne D, Milos G, Goetze O, Fried M, Schwizer W, Fox M, Steingoetter A: 
Relationship of body weight with gastrointestinal motor and sensory function: studies 
in anorexia nervosa and obesity. BMC Gastroenterol 2017, 17(1):4. 
31. 
Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, 
Hannallah R, Yu B et al: Development and feasibility of a scale to assess postoperative 
recovery: the post-operative quality recovery scale. Anesthesiology 2010, 113(4):892-905. 
32. 
Fong TG, Fearing MA, Jones RN, Shi P, Marcantonio ER, Rudolph JL, Yang FM, Kiely DK, 
Inouye SK: Telephone interview for cognitive status: Creating a crosswalk with the Mini-
Mental State Examination. Alzheimers Dement 2009, 5(6):492-497. 
33. 
Gursoy C, Ok G, Aydin D, Eser E, Erbuyun K, Tekin I, Baytur Y, Uyar Y: Effect of 
Anaesthesia Methods for Regaining Daily Life Activities in Cesarean Patients. Turk J 
Anaesthesiol Reanim 2014, 42(2):71-79. 
34. 
Apfel CC, Philip BK, Cakmakkaya OS, Shilling A, Shi YY, Leslie JB, Allard M, Turan A, Windle 
P, Odom-Forren J et al: Who is at risk for postdischarge nausea and vomiting after 
ambulatory surgery? Anesthesiology 2012, 117(3):475-486. 


STU2018-0411, Moon, Form A3, Mod_7, 08-05-19 
 
 
 
Page 13 of 21 
35. 
Niraj G, Kelkar A, Kaushik V, Tang Y, Fleet D, Tait F, McMillan T, Rathinam S: Audit of 
postoperative pain management after open thoracotomy and the incidence of chronic 
postthoracotomy pain in more than 500 patients at a tertiary center. J Clin Anesth 2017, 
36:174-177. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


STU2018-0411, Moon, Form A3, Mod_7, 08-05-19 
 
 
 
Page 14 of 21 
Appendix 1: Postoperative Quality Recovery Scale evaluation at baseline, T15, T40, T80 
 
Demographic and Preoperative Dataa 
Age  
yrs 
Gender 
Male or Female 
ASA Status 
1     2     3     4 
Weight 
kg 
Height 
in 
BMI 
kg/m2 
Education 
Highest level finished: 
Alcohol consumption 
units/wk 
Smoking status 
Never, used to but quit, current smoker 
Employment 
Unemployed  
Employed and plan to return 
Employed but plan not to return 
Occupation:  
Approximate hrs/wk: 
Inpatient 
Yes or No 
Surgical procedure 
 
Physiological Factorsa,d 
P1 Blood Pressure 
Please record the patient’s blood 
pressure 
 
 
3= SBP 90-140; 2= SBP 70-89 or 141-180;  
1= SBP <70 or >180 
P2 Heart Rate 
Please record the patient’s heart rate 
 
 
3= 45-100; 2= 35-44 or 101-139; 1= <35 or 
>140 
P3 Temperature 
Please record the patient’s 
temperature 
Method 1. Sublingual 2. Tympanic 3. 
Esophageal 
 
3= 36-37.6; 2= 35-35.9 or 37.7-38.9; 1= <35 
or >39 
P4 Respiration 
Please record the patient’s respiratory 
rate 
                        
 /breaths per minute 
P5 Oxygen use to maintain SpO2 
Please record oxygen requirement 
3= Oxygen administered by protocol or not 
required 
2= Any SpO2 <95% requiring oxygen as an 
intervention 
1= Any SpO2 <90% requiring oxygen as an 
intervention 
P6 Airway 
Please record the number 
corresponding to the assessment 
3= Self-maintenance of airway 
2= Maintenance of airway with support 
(describe) 
1= Device in situ 
P7 Agitation 
Please record the number 
corresponding to the assessment 
3= Shows no signs of agitation 
2= Patient shows occasional agitation 
1= Patient shows severe agitation 
 
 
P8 Alertness 
Please record the number 
corresponding to the actual 
 
 
5= Awake, following commands 
4= Responds to name spoken in normal tone 
3= Responds only after name is spoken 
/


STU2018-0411, Moon, Form A3, Mod_7, 08-05-19 
 
 
 
Page 15 of 21 
assessment 
loudly and repeatedly or both 
2= Responds only after mild prodding or 
shaking 
1= Does not respond to mild prodding or 
shaking 
P9 What is the level of your strength now? 
Please record the number 
corresponding to the actual 
assessment 
 
3= No weakness 
2= A little weak 
1= Very weak 
Nociceptive Factorsa,b,c 
N1 I am going to show you a series of faces 
and I would like you to indicate which face, 
number or description most accurately 
describes your level of pain at the moment.  
 
N2 I am going to show you a series of faces 
and I would like you to indicate which face, 
number, or description most accurately 
describes your level of feeling nauseous or 
vomiting at the moment.  
 
Emotional Factorsa,b 
E1 I am going to show you a series of faces 
and I would like you to indicate which face, 
number, or description accurately describes 
to what extent you feel sad, low, or 
depressed at the moment.  
 
E2 I am going to show you a series of faces 
and I would like you to indicate which face, 
number, or description accurately describes 
to what extent you feel anxious or nervous at 
the moment.  
 
a. Patient questionnaire adapted from Royse et al. 2010 and Amorim et al. 2014 
b. Pain, depression, and anxiety scales are modified from Wong and Baker 1988 
c. Nausea scale is modified from Baxter et al. 2011 
d. Alertness scale adapted from Doufas et al. 2001 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


STU2018-0411, Moon, Form A3, Mod_7, 08-05-19 
 
 
 
Page 16 of 21 
 
 
Appendix 2: Anesthesia Protocol for Reversal of Neuromuscular Blockade in Patients with 
Severe Renal Impairment 
 
 
1. Monitoring 
a. Standard ASA monitors + BIS monitor 
b. All patients will be monitored with a TwitchView accelerometer device at 15-minute 
intervals.  This device records real time feedback of the strength of contraction and 
graphically displays the relevant ratios. 
2. Induction 
a. Propofol 1.5 – 2.0 mg/kg 
b. Fentanyl 1 – 1.5 mcg/kg 
c. Lidocaine 0.5 – 1.0 mg/kg 
d. NMBD Syringe (will contain either cisatracurium 0.2 mg/kg OR rocuronium 0.6 mg/kg)-  
3. Maintenance Anesthesia:   
a. FiO2 50% (No Nitrous Oxide) 
b. Fentanyl ~ 0.5-1 mcg/kg/hr in divided doses as appropriate  
c. Sevoflurane inhalational anesthesia to maintain BIS 40-60 
d. Maintenance NMBD at 0.015 mL/kg (equal to rocuronium in 0.15 mg/kg increments or 
Cisatracurium in 0.03 mg/kg increments) 
e. Keep TOF at 1 until 30 minutes prior to anticipated conclusion of surgery (allow TOF to 
reach 2 twitches before reversal!) 
f. 
Bair Hugger to maintain normothermia 
g. Ventilatory parameters to maintain normocapnia 
4. Prophylaxis  
a. Ondansetron 4 mg 
b. Dexamethasone 4 mg 
5. Reversal 
a. The patient will be randomized to receive sugammadex vs. neostigmine/glycopyrrolate.  
A research assistant will bring a 10mL syringe labeled ‘reversal agent’ to the OR.  You 
will not be told what reversal agent the patient has been randomized to receive, as this 
is a double-blinded study.  The syringe will contain either sugammadex 2mg/kg or 
neostigmine 50 mcg/kg mixed with glycopyrrolate 10 mcg/kg. 
b. Please administer the reversal agent at the START of skin closure and mark this time 
in EPIC with a Quick Note.  
6. Extubation 
a. Patients will be extubated when all extubation criteria are met  
b. Patients will be transported to the PACU with 8L/min O2 by face mask 
7. Post-anesthesia Care Unit (PACU) 
a. T0 will be the time the patient arrives to the PACU. 
b. All vital signs will be recorded every 10 minutes while the patient is in the PACU. 
c. The first postoperative PQRS assessment will occur 15 minutes after arrival to the 
PACU (T15), the second PQRS assessment will occur 40 minutes after arrival to the 
PACU (T40), and the third PQRS assessment will occur 80 minutes after arrival to the 
PACU (T80). 
d. Patients will be weaned from supplemental oxygen to keep SpO2 ≥ 94%.   
e. The time at which the patient meets all criteria for discharge from the PACU will be 
recorded, as well as the actual PACU duration. 
 
 
 


STU2018-0411, Moon, Form A3, Mod_7, 08-05-19 
 
 
 
Page 17 of 21 
Appendix 3: Postoperative Quality Recovery Scale evaluation at POD1 and POD2** 
 
Physiological Factorsa,d 
P1 Blood Pressure 
Please record the patient’s blood 
pressure 
 
 
3= SBP 90-140; 2= SBP 70-89 or 141-180;  
1= SBP <70 or >180 
P2 Heart Rate 
Please record the patient’s heart rate 
 
 
3= 45-100; 2= 35-44 or 101-139;  
1= <35 or >140 
P3 Temperature 
Please record the patient’s 
temperature 
Method 1. Sublingual 2. Tympanic 3. 
Esophageal 
 
3= 36-37.6; 2= 35-35.9 or 37.7-38.9; 1= <35 
or >39 
P4 Respiration 
Please record the patient’s respiratory 
rate 
                       
  /breaths per minute 
P5 Oxygen use to maintain SpO2 
Please record oxygen requirement 
3= Oxygen administered by protocol or not 
required 
2= Any SpO2 <95% requiring oxygen as an 
intervention 
1= Any SpO2 <90% requiring oxygen as an 
intervention 
P6 Airway 
Please record the number 
corresponding to the assessment 
3= Self-maintenance of airway 
2= Maintenance of airway with support 
(describe) 
1= Device in situ 
P7 Agitation 
Please record the number 
corresponding to the assessment 
3= Shows no signs of agitation 
2= Patient shows occasional agitation 
1= Patient shows severe agitation 
P8 Alertness 
Please record the number 
corresponding to the actual 
assessment 
5= Awake, following commands 
4= Responds to name spoken in normal 
tone 
3= Responds only after name is spoken 
loudly and repeatedly or both 
2= Responds only after mild prodding or 
shaking 
1= Does not respond to mild prodding or 
shaking 
P9 What is the level of your strength now? 
Please record the number 
corresponding to the actual 
assessment 
 
3= No weakness 
2= A little weak 
1= Very weak 
 
 
 
 
 
 
 
 
 
/


STU2018-0411, Moon, Form A3, Mod_7, 08-05-19 
 
 
 
Page 18 of 21 
 
 
Nociceptive Factorsa,b,c 
N1 I am going to show you a series of faces 
and I would like you to indicate which face, 
number or description most accurately 
describes your level of pain at the moment.  
 
N2 I am going to show you a series of faces 
and I would like you to indicate which face, 
number, or description most accurately 
describes your level of feeling nauseous or 
vomiting at the moment.  
 
Emotional Factorsa,b 
E1 I am going to show you a series of faces 
and I would like you to indicate which face, 
number, or description accurately describes 
to what extent you feel sad, low, or 
depressed at the moment.  
 
E2 I am going to show you a series of faces 
and I would like you to indicate which face, 
number, or description accurately describes 
to what extent you feel anxious or nervous at 
the moment.  
 
Activities of Daily Livinga  
A1 Able to breathe easily  
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
A2 Been able to enjoy food 
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
A3 Feeling rested 
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
A4 Have had a good sleep  
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
A5 Able to look after personal toilet and hygiene   
      unaided  
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
A6 Able to communicate with family or friends 
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
A7 Getting support from hospital doctors and 
nurses 
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
A8 Able to return to work or usual home 
activities 
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
A9 Feeling comfortable and in control  
Please record the number corresponding to the 
0 to 10,  
where 0=none of the time [poor] and 10=all 


STU2018-0411, Moon, Form A3, Mod_7, 08-05-19 
 
 
 
Page 19 of 21 
actual assessment 
of the time [excellent] 
A10 Having a feeling of general well-being  
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
Overall Patient Satisfactiona 
O1 Patient Satisfaction 
Please record the number corresponding 
to the actual assessment 
5= Very satisfied 
4= Satisfied 
3= Moderately satisfied 
2= Unsatisfied 
1= Very Unsatisfied 
Nociceptive Factorsa,b,c 
N1 I am going to show you a series of faces 
and I would like you to indicate which face, 
number or description most accurately 
describes your level of pain at the moment.  
 
N2 I am going to show you a series of faces 
and I would like you to indicate which face, 
number, or description most accurately 
describes your level of feeling nauseous or 
vomiting at the moment.  
 
Emotional Factorsa,b 
E1 I am going to show you a series of faces 
and I would like you to indicate which face, 
number, or description accurately describes 
to what extent you feel sad, low, or 
depressed at the moment.  
 
E2 I am going to show you a series of faces 
and I would like you to indicate which face, 
number, or description accurately describes 
to what extent you feel anxious or nervous at 
the moment.  
 
Activities of Daily Livinga  
A1 Able to breathe easily  
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
A2 Been able to enjoy food 
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
A3 Feeling rested 
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
A4 Have had a good sleep  
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
A5 Able to look after personal toilet and hygiene   
      unaided  
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
A6 Able to communicate with family or friends 
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
A7 Getting support from hospital doctors and 
nurses 
0 to 10,  
where 0=none of the time [poor] and 10=all 


STU2018-0411, Moon, Form A3, Mod_7, 08-05-19 
 
 
 
Page 20 of 21 
Please record the number corresponding to the 
actual assessment 
of the time [excellent] 
A8 Able to return to work or usual home 
activities 
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
A9 Feeling comfortable and in control  
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
A10 Having a feeling of general well-being  
Please record the number corresponding to the 
actual assessment 
0 to 10,  
where 0=none of the time [poor] and 10=all 
of the time [excellent] 
Overall Patient Satisfactiona 
O1 Patient Satisfaction 
Please record the number corresponding 
to the actual assessment 
5= Very satisfied 
4= Satisfied 
3= Moderately satisfied 
2= Unsatisfied 
1= Very Unsatisfied 
** Patients who are discharged home by POD 2 will not be assessed in the physiological domain 
a. Patient questionnaire adapted from Royse et al. 2010 and Amorim et al. 2014 
b. Pain, depression, and anxiety scales are modified from Wong and Baker 1988 
c. Nausea scale is modified from Baxter et al. 2011 
d. Alertness scale adapted from Doufas et al. 2001 
 
 
 
 
 
 
 
 
 
 


STU2018-0411, Moon, Form A3, Mod_7, 08-05-19 
 
 
 
Page 21 of 21 
Appendix 4: Study Flowchart 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study cohort of patients 
Randomization 
CIS/NEO 
ROC/SUG 
PACU 
T15 
PACU 
ParametersP
T40 
POD 1 
POD 2-30 
PQRS 
PQRS & adverse 
event monitoring 
Pre-operative 
PQRS 
PQRS 
Pre-
Operative
Intra-
Operative
Post-
Operative
PQRS 
Intraoperative 
ParametersP
arameters
T80 
PQRS 

ICF_001.pdf: 
Title of Study: Reversal of Neuromuscular Blockade in Patients with Severe Renal 
Impairment; STU-2018-0411 
 
STU2018-0411, Moon, Form E, Mod_5, 07-10-19 
 
 
Page 1 of 11 
                           
UTSW Research Consent and Authorization Documents (v June 2018) 
 
DO NOT DISCLOSE 
 
CONSENT TO BE PART OF A RESEARCH STUDY 
TO BE CONDUCTED AT  
 
Parkland Health & Hospital System 
 
Key Information about this Study  
This study is being done to see if one drug that is used to reverse neuromuscular blockade (temporary paralysis 
of your muscle during surgery so that you don’t move) is better than an older drug.  Up until 2016, the drug used 
to reverse neuromuscular blockade in the USA was neostigmine.  On December 15, 2015, the FDA approved a 
new medication for this same purpose called sugammadex, which became available at Parkland in 2016.  The 
newer drug has a higher acquisition cost than the older drug but has been shown in numerous studies to be faster 
and better (i.e., more complete recovery) than the old drug.   
 
This study is being done to see if paralysis with rocuronium and reversal with sugammadex is superior (better) 
than paralysis with cisatracurium and reversal with neostigmine.  The latter is the current standard of care and 
what you would likely receive if you chose not to participate in the study.  If you chose to participate in the study, 
there is a 50% chance you will get randomized (like picking straws) to the older drug and 50% chance you will get 
randomized to the newer drug.   
 
The research team will follow you while you are in the operating room and for 30 days following surgery to make 
sure you don’t get discharged from the hospital and have to come back or that you don’t have any other 
unexpected events.  You will have continuous pulse oximetry (a sticker on your finger) for 24 hours after surgery.  
If you are on dialysis, you will resume your normal dialysis schedule once you are out of surgery.  This study is 
not intended to directly benefit the participants, although it is possible and we hypothesize that patients who get 
the newer drugs will recovery faster and have less complications, but this is not guaranteed, and we cannot 
assign which group you will be in.  The additional risks beyond what you would already have with the anesthesia 
and surgery are that you might be allergic to one of the drugs we give you.  Otherwise, the rest of your anesthetic 
care and surgery would be exactly the same as if you were not participating in the study. 
 
  
Information About This Form 
You may be eligible to take part in a research study.  This form provides important information about the 
study.   
 
Please take the time to review this information carefully. You should talk to the researchers about the 
study and ask them any questions that you may have. You may also want to talk to others (for example, 
your friends, family, or a doctor) about your participation in this study. If you decide to take part in the 
study, you will be asked to sign this form. Before you sign this form, be sure you understand what the 
study is about, including the risks and possible benefits to you. 
 
Please tell the researchers or study staff if you are taking part in another research study. 
 
Your doctor is a research investigator in this study. S/he is interested in both your medical care and the 
conduct of this research study. At any time, you may discuss your care with another doctor who is not 
part of this research study. You do not have to take part in any research study offered by your doctor. 
 
Voluntary Participation  
You do not have to participate if you don't want to.  You may also leave the study at any time. If you 
decide to stop taking part in this research study, it will not affect your relationship with the UT 
Southwestern staff or doctors. Whether you participate or not will have no effect on your legal rights or 
the quality of your health care. 


Title of Study: Reversal of Neuromuscular Blockade in Patients with Severe Renal 
Impairment; STU-2018-0411 
 
STU2018-0411, Moon, Form E, Mod_5, 07-10-19 
 
 
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DO NOT DISCLOSE 
 
If you are a medical student, fellow, faculty, or staff at the Medical Center, your status will not be affected 
in any way. 
 
General Information – “Who is conducting this research?” 
 
Principal Investigator 
The Principal Investigator (PI) is the researcher directing this study; the PI is responsible for protecting 
your rights, safety and welfare as a participant in the research. The PI for this study is Tiffany Moon MD., 
Department of Anesthesiology and Pain Management at UT Southwestern Medical Center and Parkland 
Health Hospital System. 
 
Conflict of Interest  
Merck, a for-profit company, is funding this study.  The Principal investigator designed the study and 
drafted the study plan. Merck is providing money to UT Southwestern Medical Center, so that the 
researchers can conduct the study. The PI received grant funding and honoraria from Merck in 
2018.  Honoraria will not continue in 2019, but grant funding will.   
 
 
Purpose – “Why is this study being done?” 
 
Prior studies show that recovery from neuromuscular blockade (medicine that relaxes your muscles so 
the surgeon can do the surgery) with rocuronium is significantly faster with sugammadex (a new drug 
that just recently became available in the USA in 2015) versus cisatracurium and neostigmine (old drugs 
that are currently being used). Use of sugammadex has been shown to be safe in patients with a history 
of end stage renal disease. This study is being done to determine whether muscle paralysis with 
rocuronium can be more quickly and better reversed with sugammadex when compared to reversal of 
cisatracurium-induced neuromuscular blockade with neostigmine in patients with severe renal 
impairment.  
 
• 
Researcher means the study doctor or research personnel at the University of Texas 
Southwestern Medical Center at Dallas and its affiliated hospitals such as Parkland Heath 
Hospital System. 
• 
Standard medical care is the regular care you would receive from your doctor if you choose not 
to participate in this research. 
• 
Neuromuscular blockade is paralyzing skeletal muscles with muscle blockers such as 
rocuronium or cisatracurium during surgery. 
• 
Reversal agents are medicines such as sugammadex and neostigmine that recover paralyzed 
skeletal muscle at the end of the surgery. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This website will not include information that can identify you. At most, the website will include a 
summary of the results. You can search this website at any time.  
  
Information about Study Participants – “Who is participating in this research?” 
 
You are being asked to be a participant in this study because your kidneys are not working well, and you 
are scheduled to undergo surgery that requires us to paralyze your muscles. 
 
How many people are expected to take part in this study?  


Title of Study: Reversal of Neuromuscular Blockade in Patients with Severe Renal 
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This study will enroll a total of about 60 study participants. 
 
Information about Study Procedures – “What will be done if you decide to be in the 
research?” 
 
Screening – After you sign this consent to participate, exams, tests, and/or procedures may be done as 
described below to find out if you can continue in the study; this is called screening. We may be able to 
use the results of exams, tests, and/or procedures you completed before enrolling in this study.  These 
procedures are described below as “standard care” and would be done even if you do not take part in 
this research study. 
 
Screening Procedures 
- The results of the physical examination done as part of your standard care will be used. 
- If you are capable of becoming pregnant, a pregnancy test will also be done before you receive study 
treatment. 
- Your eligibility will be determined by reviewing your medical record. 
- Your heart rhythm (ECG) or radiological results will be also reviewed. 
 
The results of the screening exams, tests, and/or procedures will be reviewed to determine whether you 
will be allowed to continue in the study.  If you are not allowed to continue in the study, the researcher 
will discuss the reasons with you. 
 
Assignment to Study Groups  
When it is determined that you are eligible for the study, you will be assigned by chance (like flipping a 
coin) to) to receive either rocuronium and sugammadex or cisatracurium and neostigmine+glycopyrrolate 
in the operating room 
  
1) Cisatracurium / neostigmine + glycopyrrolate. Your muscles will be paralyzed with cisatracurium 
during surgery and then neostigmine + glycopyrrolate will be used to recover your muscles at 
the end of the surgery.  
2) Rocuronium / sugammadex. Your muscles will be paralyzed with rocuronium during surgery and 
then sugammadex will be used to recover your muscles function at the end of the surgery.  
 
Neither you nor the researchers will know which muscle blockers and reversal agents you receive during 
surgery.  In the event of an emergency, there is a way for the researcher to find out which medication 
you received. 
Study Procedures - as a participant, you will undergo the following procedures: 
• 
You will be randomly assigned to one of the two study groups. 
• 
In the operating room, your muscles will be paralyzed with muscle blockers cisatracurium or 
rocuronium.  This is standard of care.  
• 
You will be randomized to receive either neostigmine or sugammadex for reversal of neuromuscular 
paralysis. Sugammadex or neostigmine are approved by FDA to recover muscles paralysis. 
Neostigmine is commonly used reversal agent in the standard practice. Sugammadex is a new drug. 
Both reversal agents are standard of care. 
• 
You will complete a questionnaire before the surgery and again after surgery. This questionnaire will 
be filled out 3 times: at 15 minutes, 40 minutes, and 80 minutes after surgery. (research only). It will 
take approximately 1-2 minutes. 
• 
You will fill out a brief questionnaire on postoperative days 1 and day 2, either in your hospital room 
or over the phone from home. It will take approximately 3-5 minutes. (Research only). 
 


Title of Study: Reversal of Neuromuscular Blockade in Patients with Severe Renal 
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You will be in this study approximately 30 days from the start of anesthesia until 30 days after surgery.  
 
Could your participation end early? There are several reasons why the researchers may need to end 
your participation in the study (early withdrawal).  Some reasons are: 
• 
The researcher believes that it is not in your best interest to stay in the study. 
• 
You become ineligible to participate. 
• 
Your condition changes and you need treatment that is not allowed while you are taking part in the 
study. 
• 
You do not follow instructions from the researchers. 
 
Risks – “What are the risks of participation in the research?” 
 
The investigators have designed this study to learn how well the new treatment(s) compare to commonly 
accepted treatment(s).  
 
There is not much additional risk by participating in this study, above the standard risks associated with 
surgery and general anesthesia.  There is a 0.3% chance that you may be allergic to sugammadex.  The 
anesthetic management of subjects will not differ from the standard care.   
 
Everyone taking part in the study will be watched carefully for any side effects.  However, the study 
doctors don’t know all the side effects that may happen.  Be sure to tell your study doctor immediately 
about any side effect that you have while taking part in the study. 
 
The following section will describe the risks related to your participation in this research study.  You 
should talk to your study doctor about any side effects or other problems that you have while taking part 
in the study.    
Risks from the specific research procedures (drug(s) 
Side effects can range from mild to serious.  Serious side effects are those that may require 
hospitalization, are life threatening or fatal (could cause death).  The frequency that people experience a 
certain side effect can range from many (likely), few (less likely) or only one or two (rarely).   
 
Risks of Rocuronium  
The most common adverse reactions after administration of rocuronium are nausea, vomiting, light 
headedness, and minor changes in blood pressure. 
 
Frequent 
Occasional 
Rare 
Serious 
 
Residual 
neuromuscular 
blockade 
Severe allergic reaction 
Less Serious 
 
 
 
Minor 
Nausea, 
Vomiting, 
Light 
Headedness, 
Minor 
changes 
in 
blood pressure 
Injection 
site 
pain, 
Itching 
 
 
Risks of Cisatracurium  
The most common adverse reactions after administration of cisatracurium are nausea, vomiting, light 
headedness, and minor changes in blood pressure. 
 
Frequent 
Occasional 
Rare 


Title of Study: Reversal of Neuromuscular Blockade in Patients with Severe Renal 
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Serious 
 
Residual 
neuromuscular 
blockade 
Severe allergic reaction 
Less Serious 
 
 
 
Minor 
Nausea, 
Vomiting, 
Light 
Headedness, 
Minor 
Changes 
in 
blood pressure 
Injection 
site 
pain, 
Itching/rash 
 
 
Risks of Neostigmine 
The most common adverse reactions after administration of neostigmine are nausea, vomiting, and low 
heart rate, but another drug called glycopyrrolate is always given along with neostigmine to counteract 
the potential drop in heart rate. 
 
Frequent 
Occasional 
Rare 
Serious 
 
 
Severe allergic reaction 
Less Serious 
Low heart rate 
Low blood pressure, low 
oxygen level 
 
Minor 
Nausea, Vomiting, Dry 
mouth 
Injection 
site 
pain, 
Itching 
 
 
Risks of Glycopyrrolate 
The most common adverse reactions after administration of glycopyrrolate are dry mouth, 
nausea/vomiting, and headache.  
 
 
Frequent 
Occasional 
Rare 
Serious 
 
 
Severe rise in body 
temperature 
Abnormal heart rhythm 
Less Serious 
 
High heart rate, Trouble 
urinating, blurred vision, 
light sensitivity 
High 
or 
low 
blood 
pressure 
Minor 
Nausea, Vomiting, Dry 
mouth 
Itching, 
Dry 
skin, 
diarrhea, constipation 
 
Risks of Sugammadex: 
The most common adverse reactions after administration of sugammadex are allergy, nausea/vomiting, 
pain, hypotension, and headache.  
 
Sugammadex is mainly expelled from the body through the kidney (i.e., via urine). It is an FDA 
approved drug but not recommended if there is severe renal impairment, meaning that your kidneys 
don’t work very well. The reason for this is because there have not been very many studies done on 
this patient population.  Sugammadex may take longer to clear from your body since it comes out 
through urination, and patients with severe renal impairment (meaning your kidneys don’t work very 
well) may not make much urine. Think of sugammadex like a donut and rocuronium like a donut hole.  
Since sugammadex wakes your muscles back up by attaching to rocuronium (the drug that puts your 
muscles to sleep) to form a sugammadex-rocuronium complex, people sometimes fear that 
sugammadex and rocuronium will become separated and there is a very theoretical concern that 
patients could become weak again.  This has never been reported to happen. In the previous studies 
that have been done, it has been shown that sugammadex attaches to rocuronium very strongly, 
meaning that once the donut attaches to the donut hole, you cannot separate the two.  One 


Title of Study: Reversal of Neuromuscular Blockade in Patients with Severe Renal 
Impairment; STU-2018-0411 
 
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study published in 2013 stated that for every 25 million sugammadex-rocuronium complexes formed, 
only 1 becomes separated, demonstrating that the risk is very low. 
 
 
Hormonal birth control pills may be less effective when sugammadex is used as a reversal agent and 
increases the risk of the pregnancy for 7 days after surgery.   
• 
Female participants who are using hormone (birth control pills) have to use a barrier method 
(hormone-free birth control methods) such as condoms and spermicide for 7 days.  
• 
If you chose to participate, research team will give you a letter in your language with the 
information regarding birth control after surgery and phone number of the PI if they have any 
additional questions. 
 
 
Frequent 
Occasional 
Rare 
Serious 
 
 
Severe Allergic Reaction 
Low heart rate 
Less Serious 
 
High 
or 
low 
blood 
pressure 
 
Minor 
Nausea, 
Vomiting, 
Pain, Headache 
Itching, Dizziness 
 
 
Psychological Stress 
There is minimal risk for psychological stress to the patient as a result of participating in this study. You 
may refuse to answer any of the questions, take a break, or stop your participation in this study at any 
time. 
 
Loss of Confidentiality 
Any time information is collected there is a potential risk for loss of confidentiality.  Every effort will be 
made to keep your information confidential; however, this cannot be guaranteed.  
 
Other Risks 
There may possibly be other side effects that are unknown at this time. If you are concerned about other, 
unknown side effects, please discuss this with the researchers. 
 
For more information about risks and side effects, ask one of the researchers or study staff. 
 
Reproductive Risks 
If you are a woman who is pregnant or could be pregnant, you cannot take part in this study because we 
do not know how the muscle relaxant and their reversal agents might affect a developing fetus.  We will 
do a pregnancy test before your study enrolment to make sure you are not pregnant.  If you participate 
in the study, you must use one of the barrier methods or back up method of birth control for a period of 7 
days after the surgery. If you do not wish to do so, you will not eligible for the study.  
 
Are there Risks related to withdrawing from the study?  
If you decide to withdraw from this study early, please discuss your decision with the principal investigator.  
The researcher may ask you to complete a study withdrawal form. There is no risk to you if you do not 
complete the final withdrawal procedures and you can choose not to participate in them. 
 
Are there risks if you also participate in other research studies? 


Title of Study: Reversal of Neuromuscular Blockade in Patients with Severe Renal 
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Being in more than one research study at the same time, may increase the risk to you.  It may also affect 
the results of the studies.  You should not take part in more than one study without approval from the 
researchers.   
 
What if a research-related injury occurs?  
The researchers have taken steps to minimize the known or expected risks.  However, you may still 
experience problems or side effects, even though the researchers are careful to avoid them.  In the event 
of a research-related injury or if you experience an adverse reaction, please immediately contact your study 
doctor.  See the section “Contact Information” for phone numbers and additional information.  You may 
also need to tell your regular doctors. 
 
If you are injured from taking part in this research study, medical care will be provided. This care may be 
billed to you or your insurance. Depending on the circumstances, this care may be provided at no cost to 
you. We have no plans to give you money if you are injured. The investigator can provide you with more 
information. 
 
If you sign this form, you do not give up your right to seek additional compensation if you are harmed as 
a result of being in this study. 
 
Benefits – “How could you or others benefit from your taking part in this study?” 
 
You may not receive any personal benefits from being in this study. However, there may be potential for 
a direct benefit to you if you are assigned sugammadex group. Investigators intend to evaluate if 
sugammadex is superior to neostigmine for reversal of muscle function at the end of the surgery. 
 
We hope the information learned from this study will benefit other people with similar conditions in the 
future. 
 
Alternative procedures or course of treatment – “What other options are there to participation 
in this study?” 
 
If you chose not to participate in the study, you will undergo general anesthesia with standard of care 
medications. 
 
 
. 
 
Costs – Will taking part in this study cost anything? 
 
You or your health insurance company will be responsible for the cost of treatments and procedures that 
would be done whether or not you took part in this study, such as the surgery, general anesthesia, and 
postoperative care.  You will not be charged for any muscle blockers or reversal agents if you decide to 
participate in this study. 
 
It is important to understand that some insurance companies do not cover some costs. If your insurance 
company does not cover these treatments or procedures, you will be required to pay for them. Ask the 
researchers if you have any questions about what it will cost you to take part in this study (for example 
bills, fees, or other costs related to the research). 
 
Confidentiality – How will your records be kept confidential? 
 


Title of Study: Reversal of Neuromuscular Blockade in Patients with Severe Renal 
Impairment; STU-2018-0411 
 
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DO NOT DISCLOSE 
Information we learn about you in this study will be handled in a confidential manner, within the limits of 
the law.  If we publish the results of the study in a scientific journal or book, we will not identify you.  The 
Institutional Review Board and other groups that have the responsibility of monitoring research may want 
to see study records which identify you as a subject in this study.    
 
HIPAA Section:  
Research policies require that private information about you be protected and this is especially true for 
your health information. However, the law sometimes allows or requires others to see your information.  
The information given below describes how your privacy and the confidentiality of your research records 
will be protected in this study. Medical information collected during this study and the results of any test 
or procedure that may affect your medical care may be included in your medical record. The information 
included in your medical record will be available to health care providers and authorized persons including 
your insurance company. 
 
What is Protected Health Information (PHI)?   
Protected Health Information is information about a person’s health that includes information that would 
make it possible to figure out whose it is.  According to the law, you have the right to decide who can see 
your protected health information. If you choose to take part in this study, you will be giving your 
permission to the investigators and the research study staff (individuals carrying out the study) to see 
and use your health information for this research study.  In carrying out this research, the health 
information we will see and use about you will include:  
 
Your medical history and blood work, information that we get from your medical record, information 
contained in your underlying medical records related to your medical history and treatments prior to the 
study, information that is created or collected during your participation in the study including medical, 
surgical and treatment history, your physical status, weight, height, body mass index, blood pressure, 
heart rate, respiration, continuous heart rhythm, blood oxygen level, any adverse event during surgery, 
anesthetic agents, muscle blocker, and reversal of muscle function for general anesthesia, temperature, 
depth of the anesthesia,  information you give us during your participation in the study such as 
demographic information like your age, questionnaires including your pain, emotion, and satisfaction. 
protected heath information including your name, date of birth, medical record number, and phone 
number.  
 
We will get this information by asking you, your doctor, and looking at your chart at Parkland Hospital. 
 
How will your PHI be shared?   
Because this is a research study, we will be unable to keep your PHI completely confidential.  We may 
share your health information with people and groups involved in overseeing this research study 
including: 
• 
The following collaborators at other institutions that are involved with the study:  Parkland Health & 
Hospital System  
• 
The committee that checks the study data on an ongoing basis, to determine if the study should be 
stopped for any reason 
• 
The members of the local research team. 
• 
The Institutional Review Board, Human Research Protection Program Office and the Compliance 
Office of the University of Texas Southwestern Medical Center, and other groups that oversee how 
research studies are carried out.  
• 
The Research offices at: The University of Texas Southwestern Medical Center, Parkland Health 
and Hospital System.  


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• 
The Food and Drug Administration (FDA) and other U.S. and international governmental regulatory 
agencies involved in overseeing drug or device research. 
• 
Representatives of domestic and foreign governmental and regulatory agencies may be granted 
direct access to your health information for oversight, compliance activities, and determination of 
approval for new medicines, devices, or procedures.   
 
If you decide to participate in this study, you will be giving your permission for the groups named above, 
to collect, use and share your health information.  If you choose not to let these groups collect, use and 
share your health information as explained above, you will not be able to participate in the research study. 
 
Parts of your PHI may be photocopied and sent to a central location or it may be transmitted electronically, 
such as by e-mail or fax. The groups receiving your health information may not be obligated to keep it 
private.  They may pass information on to other groups or individuals not named here.   
 
How will your PHI be protected?   
In an effort to protect your privacy, the study staff will use code numbers instead of your name, to identify 
your health information.  Initials and numbers will be used on any photocopies of your study records, and 
other study materials containing health information for review.  If the results of this study are reported in 
medical journals or at meetings, you will not be identified. 
 
Do you have to allow the use of your health information? 
You do not have to allow (authorize) the researchers and other groups to see and share your health 
information.  If you choose not to let the researchers and other groups use your health information, there 
will be no penalties, but you will not be allowed to participate in the study.   
 
After you enroll in this study, you may ask the researchers to stop using your health information at any 
time.  However, you need to say this in writing and send your letter to Tiffany Moon MD. Department of 
Anesthesiology and Pain Management at UT Southwestern Medical Center, 5323 harry Hines Blvd, 
Dallas, TX, 75390-9068.  If you tell the researchers to stop using your health information, your 
participation in the study will end and the study staff will stop collecting new health information from you 
and about you for this study.  However, the study staff will continue to use the health information collected 
up to the time they receive your letter asking them to stop. 
 
Can you ask to see the PHI that is collected about you for this study?   
The federal rules say that you can see the health information that we collect about you and use in this 
study.  Contact the study staff if you have a need to review your PHI collected for this study. 
  
Because of the type of research, you can only access your PHI when the study is done.  At that time, you 
have the right to see and copy the medical information we collect about you during the study, for as long 
as that information is kept by the study staff and other groups involved.   
 
 
 
How long will your PHI be used?   
By signing this form, you agree to let us use and disclose your health information for purposes of the 
study until the end of the study.  This permission to use your personal health information expires when 
the research ends, and all required study monitoring is over. 
 
Contact Information –  
Who can you contact if you have questions, concerns, comments or complaints? 


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If you have questions now, feel free to ask us.  If you have additional questions, concerns, comments or 
complaints later or you wish to report a problem which may be related to this study please contact: Tiffany 
Moon, MD at (469) 419-5790 during regular business hours and by pager at (214) 768-2038 after hours 
and on weekends and holidays. 
 
To use the pager, you need to have a touch tone (push button) telephone.  Dial the pager number as you 
would any phone number.  When you hear 3 short high-pitched beeps, dial in the number where you 
want the doctor to call you back.  Push the # button, hang up and wait for the doctor to return your call. 
 
Primary Contact: 
Tiffany Moon, MD. can be reached at (469) 419-5790 during regular business hours and by pager at 
(214)768-2038 after hours and on weekends and holidays.  
 
The University of Texas Southwestern Medical Center Human Research Protection Program (HRPP) 
oversees research on human subjects.  HRPP and Institutional Review Board (IRB) representatives will 
answer any questions about your rights as a research subject, and take any concerns, comments or 
complaints you may wish to offer.  You can contact the HRPP by calling the office at (214) 648-3060. 
 
Research Consent & Authorization Signature Section 
 
If you agree to participate in this research and agree to the use of your protected health information in 
this research, sign this section.  You will be given a copy of this form to keep.  You do not waive any of 
your legal rights by signing this form. 
 
SIGN THIS FORM ONLY IF THE FOLLOWING STATEMENTS ARE TRUE: 
• 
You have read (or been read) the information provided above. 
• 
Your questions have been answered to your satisfaction about the research and about the 
collection, use and sharing of your protected health information. 
• 
You have freely decided to participate in this research, or you are voluntarily giving your consent 
for another person to participate in this study because you believe this person would want to take 
part if able to make the decision and you believe it is in this person’s best interest.   
• 
You understand that a copy of this signed consent document, information about this study, and 
the results of any test or procedure that may affect your medical care, may be included in your 
medical record. Information in your medical record will be available to health care providers and 
authorized persons including your insurance company. 
• 
You authorize the collection, use and sharing of your protected health information (another 
person’s protected health information) as described in this form. 
 
Adult Signature Section  
 
 
 
 
 
 
 
AM 
PM 
Printed Name of 
Participant 
 
 
 
Signature of Participant 
 
 
 
Date 
 
Time 
 
 
 
 
 
 
 
AM 
PM 
Printed Name of Person 
Obtaining Consent 
 
Signature of Person Obtaining 
Consent  
 
Date 
 
Time 


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