Conditions: Urinary Retention Postoperative Laparoscopic Cholecystectomy Neuromuscular Blockade Sugammadex Neostigmine Neuromuscular Blocking Agents Physiological Effects of Drugs
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 235
Healthy volunteers: yes

Brief summary:
This study is intended to be a single-site, prospective, randomized, controlled study that intends to enroll a total of 230 patients undergoing laparoscopic cholecystectomy at Parkland Hospital. Patients will be randomized to receive either neostigmine or sugammadex for reversal of rocuronium-induced neuromuscular blockade. 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. To account for protocol deviations and patient dropout, up to 250 randomization envelopes will be made and enrollment will continue until there are 230 completed enrollments.

Detailed description:
Objective:

To determine the incidence of postoperative urinary retention after reversal of rocuronium-induced neuromuscular blockade by neostigmine versus sugammadex in patients undergoing laparoscopic cholecystectomy.

Hypothesis:

Subjects who are reversed with sugammadex will have less postoperative urinary retention compared to subjects who are reversed with neostigmine.

Arms:
arm 1: One type of Neuromuscular Blockade Reversal Drug arm 2: One type of Neuromuscular Blockade Reversal Drug

Interventions: intervention 1: Neostigmine intervention 2: Sugammadex
Intervention descriptions: intervention 1: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine. intervention 2: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex

Protocol document:
Prot_SAP_001.pdf: 
 
STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
 
 
Official title: Postoperative Urinary Retention After Reversal of 
Neuromuscular Block by Neostigmine versus Sugammadex in Patients 
Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled 
Trial 
NCT number:  
NCT05794503 
IRB Approved Document date: 08-05-23 


Form A 
IRB # 
STU-2022-1201 
 
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PROTOCOL FORM / RESEARCH DESCRIPTION 
 
If an item does not apply to your research project, indicate that the question is "not applicable” – do not leave sections blank 
 
Click once on the highlighted entry in each box to provide your response.  Click the item number/letter or word, if hyperlinked, 
for detailed instructions for that question.  If your response requires inserting a table, picture, etc, you may need to first delete the 
box that surrounds the answer and then insert your table or other special document. 
 
 
1.  Purpose and objectives.           List the purpose and objectives: 
 
Objective 1: 
To determine the incidence of postoperative urinary retention after reversal of rocuronium-induced 
neuromuscular blockade by neostigmine versus sugammadex in patients undergoing laparoscopic 
cholecystectomy.  
  
Primary Hypothesis:  
Subjects who are reversed with sugammadex will have 70% less postoperative urinary retention 
compared to subjects who are reversed with neostigmine.  
 
 
2.  Background. 
• 
Describe past experimental and/or clinical findings leading to the formulation of your study.   
• 
For research involving investigational drugs, describe the previously conducted animal and human studies.   
• 
For research that involves FDA approved drugs or devices, describe the FDA approved uses of this drug/device in 
relation to your protocol.   
• 
Attach a copy of the approved labeling as a product package insert or from the Physician’s Desk Reference.   
You may reference sponsor’s full protocol or grant application (section number and/or title) or if none, ensure background 
includes references. 
 
Please respond to all components of this item, or clearly indicate which components are not applicable. 
 
a. 
Background 
The incidence of postoperative urinary retention (POUR) after surgery varies widely from 3-
50% and depends on various patient- and procedural-related factors [1, 2]. In an era of fast-
track surgery and enhanced recovery, urinary retention has emerged as one of the most 
common barriers to successful same-day discharge. Risk factors for POUR include male 
gender, age >50, prolonged surgery, excessive intraoperative fluids, and use of 
anticholinergics [3]. POUR can contribute to a prolonged PACU stay, patient discomfort, and 
unplanned hospital admission. Acute urinary retention can impair renal glomerular and tubular 
function [4]. POUR is usually treated with urethral catheterization, which is uncomfortable, and 
can increase the risk for infection and trauma to the urogenital tract [5]. It is estimated that 
POUR accounts for between 20-25% of unplanned inpatient admissions following planned 
outpatient surgery [6, 7]. 
 
Adequate muscle relaxation is necessary for laparoscopic procedures. Residual 
neuromuscular blockade is common and has been proven to lead to a multitude of adverse 
effects including increased postoperative pulmonary complications, longer length of hospital 
stay, and decreased quality of recovery [8, 9]. At present, it is recommended that all patients 


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who receive neuromuscular blocking agents be given reversal agents unless they have a 
documented TOF >90% prior to extubation [10]. 
 
Neostigmine (an acetylcholinesterase inhibitor) is frequently used for reversal of 
neuromuscular blockade. However, it is associated with significant muscarinic side effects 
(i.e., bradycardia) and must be co-administered with an anticholinergic such as glycopyrrolate. 
Contraction of the detrusor and internal urethral sphincter are controlled by parasympathetic 
stimulation via muscarinic receptors so blockade of these receptors by glycopyrrolate can 
induce urinary retention [11]. Numerous studies have found that administration of 
glycopyrrolate intraoperatively increase the risk of POUR [11, 12]. 
 
Sugammadex is a selective relaxant binding agent which does not have any cholinergic 
effects and thus does not contribute to POUR. Previous studies have found that the use of 
sugammadex was associated with a lower incidence of POUR in patients undergoing total 
knee arthroplasty, inguinal hernia repair, and laparoscopic cholecystectomy [13-15]. 
 
 
b. 
Current practice 
Current practice at Parkland shows that about half of patients undergoing laparoscopic 
cholecystectomy are reversed with sugammadex and half are reversed with neostigmine. The 
incidence of POUR in these patients is unknown because there have not been any formal 
studies to evaluate this outcome. There are no prospective, randomized studies evaluating the 
incidence of POUR from reversal of neuromuscular blockade with neostigmine versus 
sugammadex in patients undergoing laparoscopic cholecystectomy.  Most previous studies 
have been retrospective or did not examine POUR as the primary outcome.  
 
 
3.  Study Design.  
Describe the study design (e.g., single/double blind, parallel, crossover, etc.)  Consider inserting a scheme to visually present the 
study design. 
 
This study is intended to be a single-site, prospective, randomized, controlled study that intends 
to enroll a total of 230 patients undergoing laparoscopic cholecystectomy at Parkland Hospital. 
Patients will be randomized to receive either neostigmine or sugammadex for reversal of 
rocuronium-induced neuromuscular blockade. 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.  To account for protocol deviations and patient dropout, up to 250 randomization 
envelopes will be made and enrollment will continue until there are 230 completed enrollments. 
 
Criteria for Inclusion of Subjects: 
• 18-80 years old 
• Undergoing laparoscopic cholecystectomy  
• Anticipated surgical duration <2 hours  
• ASA physical status classification 1-3 
• Willing and able to consent in English or Spanish 
• No personal history of neuromuscular disease 


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Criteria for Exclusion of Subjects: 
• Preoperative urinary catheter 
• History of problems with urination  
• Current use of anticholinergic medications (e.g., antihistamines, phenothiazines, 
antidepressants, antipsychotics) 
• Current UTI or urogenital problem (incontinence, known bladder retention, prostate 
hypertrophy) 
• Planned intraoperative insertion of a urinary catheter 
• ESRD (eGFR <30 mL/min) 
• ESLD (AST or ALT > 3x reference range) 
• Planned postoperative intubation/ventilation or admission to ICU 
• Allergy to sugammadex, neostigmine, glycopyrrolate, or rocuronium 
• Pregnant or nursing women 
• “Stat” (emergent) cases 
• Known or suspected neurological condition (e.g., Alzheimer’s, h/o of stroke, multiple 
sclerosis, Parkinson’s) 
• Patients on toremifene (a selective estrogen receptor modulator) 
• Women on oral contraceptives who do not wish to use a non-hormonal method of 
contraception for 7 days following surgery 
 
 
 
 
4.  Research Plan / Description of the Research Methods:   
4.a.  Provide a comprehensive narrative describing the research methods.   
     1) Provide the order in which tests/procedures will be performed,  
     2) Provide the setting for these events and a description of the methods used to protect privacy during the study.   
     3) Provide the plan for data analysis (include as applicable the sample size calculation) 
 
Please respond to all components of this item, or clearly indicate which components are not applicable. 
 
1) 
Order in which tests/procedures will be performed  
 
Screening and Informed Consent: 
A member of the research team will use a screening form to look for surgical patients that meet all 
the inclusion and exclusion criteria. He/she will approach potential subjects in the preoperative 
area and the study will be explained in detail in a private room. Enrolled patients will be randomly 
assigned to the neostigmine or sugammadex groups in a 1:1 ratio using a web-based 
randomization code. These assignments will be written and put into an envelope which will be 
given to the anesthesia provider to open once a patient is consented. 
 
Baseline Subjective Measures: 
In the preoperative area, and demographic information will be gathered from Epic. 
 


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Anesthesia Protocol:  
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. A study member will provide the 
anesthesia team with an envelope containing which group the patient has been randomized into 
(neostigmine versus sugammadex). If the patient has been randomized to the neostigmine group, 
the drug will be drawn from the Pyxis per usual practice. If the patient has been randomized to the 
sugammadex group, an order will be sent to investigational drug services pharmacy (IDS) to draw 
up the sugammadex (see attachment, IDS order form). IDS Pharmacy will only be providing 
sugammadex if the patient has been randomized to that group. 
 
Subjects will receive 0.6 mg/kg of rocuronium for neuromuscular paralysis for induction.  Additional 
rocuronium will be given in 0.15 mg/kg increments to facilitate neuromuscular relaxation. All 
patients will have the depth of neuromuscular block monitored quantitatively 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.  Assessments 
of depth of neuromuscular blockade will be recorded into the patient’s electronic medical record 
every 15 minutes following intubation.  Maintenance of anesthesia will be with sevoflurane in 50% 
oxygen. All patients will have a forced air warming device (e.g., Bair Hugger, 3M, Maplewood, MN) 
used to maintain normothermia throughout the surgery.   
 
At the end of surgery, reversal of neuromuscular blockade will be achieved with either 
neostigmine or sugammadex and the patient will be extubated when the TOF ≥0.9. If the patient 
has been randomized into the sugammadex group, it will be prepared into a syringe by a 
pharmacist in Investigational Drug Service (IDS) Pharmacy. Sugammadex will be provided to 
IDS Pharmacy from the study sponsor, Merck. IDS Pharmacy will only be responsible for 
providing sugammadex, and only if the patient has been randomized to that group. The 
remaining aspects of the anesthetic will be standardized and not differ from the standard of care 
for all patients. 
 
Patients will then be taken to the PACU and monitored according to established guidelines.  
 
Randomization & Dosing: 
Patients will be randomized to one of two groups for neuromuscular blockade and reversal of 
neuromuscular paralysis: 
1. Group 1- rocuronium + neostigmine (NEO group) 
a. Induction: 0.6 mg/kg rocuronium 
b. Maintenance: additional boluses of 0.15 mg/kg rocuronium 
c. Reversal:  
i. TOF 0-1 twitch- delay reversal 
ii. TOF <0.4- 50-70 mcg/kg neostigmine (max 5 mg) + 10 mcg/kg 
glycopyrrolate (max 1 mg) 
iii. TOF 0.4-0.9- 20-40 mcg/kg neostigmine + 5 mcg/kg glycopyrrolate  
 
2. Group 2- rocuronium + sugammadex (SUG group) 
a. Induction: 0.6 mg/kg rocuronium 
b. Maintenance: additional boluses of 0.15 mg/kg rocuronium 


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c. Reversal: 
i. TOF < 2 twitches- 4 mg/kg sugammadex 
ii. TOF ≥ 2 twitches- 2 mg/kg sugammadex 
 
The statistician will make randomization envelopes by using a random number generator.  These 
envelopes will be provided to the anesthesia team after subjects are consented. The anesthesia 
team will be responsible for opening the envelope to discover which group the patient has been 
randomized to. The words ‘neostigmine’ or ‘sugammadex’ will be printed on a piece of paper and 
placed in an opaque manila envelope that bears a unique subject number. If the patient has been 
randomized into the neostigmine group, the anesthesia provider will draw up the drug from the 
Pyxis. If the patient has been randomized into the sugammadex group, the study team will contact 
the IDS Pharmacy and they will provide sugammadex. It is solely the responsibility of the research 
team to contact IDS Pharmacy in order to retrieve sugammadex.  
 
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. Any drugs given in the PACU 
will be recorded. The patient will be asked to void 45 minutes after PACU arrival. Post void residual 
will be obtained with an ultrasound. The bladder scan will be administered 60 min after arrival to 
the PACU.  
 
POUR will be defined as: 
1. Inability to spontaneously urinate and a bladder volume ≥ 300 mL [16-17] 
2. Postvoid residual > 150 mL [18-19] 
3. Need for insertion of Foley catheter or straight catheter [20] 
 
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. 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) 
• Depth of neuromuscular blockade throughout the surgery at 15-minute intervals 
• Presence of hemodynamic changes, rash, erythema, or flushing after reversal agent given 
4. PACU parameters 


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• Vitals during PACU stay (BP, temperature, HR, SpO2) every 15 minutes 
• The time when PACU discharge criteria are met 
• Total PACU time (PACU arrival to actual discharge from PACU) 
• Amount of urine voided 
• Bladder volume at T60 
5.  Adverse event monitoring 
• 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 
• Readmission after discharge 
• Inability to void prior to discharge 
• Need for insertion of a bladder catheter 
• Development of urinary tract infection (UTI) 
 
2) Setting and Methods used to Protect Privacy  
Setting 
The study will take place in the pre-operative rooms, the operating rooms, and the PACU at 
Parkland Hospital. 
 
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, and HIPAA forms, will remain in a locked cabinet in the 
PI’s office. 
 
3) Plan for Data Analysis  
Statistics: 


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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. 
 
Sample Size Justification: 
 
Sample size was calculated assuming the POUR incidence rates of 3% and 13% for the 
sugammadex and neostigmine groups, respectively.  To detect a difference of 10% with 80% 
power and 5% Type I error rate (one-sided), the estimated sample size is 115 for each group. 
 
The primary outcome is the incidence rates of postoperative urinary retention (POUR) of 
sugammadex and neostigmine groups. The difference of the incidence rates between groups will 
be analyzed using the z test with a significance level of 5%.  
 
Based upon a sample size of n=115 patients per group, this study has 80% power and 5% Type I 
error rate (one-sided) to detect a 10% difference between groups in the incidence of POUR. This 
calculation is based on prior published research estimating the incidence of POUR to be 3% and 
13% for the sugammadex and neostigmine groups, respectively.  
 
 
 
 
4.b.  List of the study intervention(s) being tested or evaluated under this protocol 
 
N/A -  this study does not test or evaluate an intervention.    Skip to item 4.d. 
# 
Study intervention(s) being tested or evaluated under the protocol 
 
 
 
Add or delete rows as needed 
 
Affiliate 
 
Place a check next to 
institution(s) where 
the  
intervention will be 
performed 
Local Standard 
Practice?  
Indicate whether the 
intervention is 
considered 
acceptable practice 
locally for applicable 
institutions 
1 
Rocuronium + neostigmine 
☐ UTSW 
☐ Yes 
☒ PHHS 
☒ Yes 
☐CMC 
☐ Yes 
☐THR 
☐ Yes 
☐TSRH 
☐ Yes 
☐ Other: _____ 
☐ Yes 
2 
Rocuronium + sugammadex 
☐ UTSW 
☐ Yes 
☒ PHHS 
☒ Yes 
☐CMC 
☐ Yes 
☐THR 
☐ Yes 
☐TSRH 
☐ Yes 
☐ Other: _____ 
☐ Yes 
 


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4.c.  Risk:Benefit Analysis of study interventions being tested or evaluated under this protocol 
For each study intervention identified in section 6b above, complete a risk:benefit analysis table. 
 
(Two tables are provided, copy & paste additional tables as needed or delete both tables if this study does not test an 
intervention) 
 
 
4.c. 
Study Intervention #1 
Rocuronium + neostigmine 
List each group exposed to this 
intervention on a separate line. 
(e.g., experimental, control, Arm A, Arm B, 
etc) 
Or state All Groups/Subjects 
For each group, list the benefits of this intervention.  (Benefits can be directly from 
the intervention or from a monitoring procedure likely to contribute to the subject’s 
well being).  If there are no benefits, state “none”. 
Group 1 (NEO) 
None 
 
 
If you are requesting a Waiver of Informed Consent, complete the table below. 
 
If you have a consent form, list the reasonably foreseeable risks in the consent form (and do not complete this section).   
 
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious). 
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms) 
Do not delete frequency.  Frequency must be estimated because it will assist you with determining which adverse events will require 
prompt reporting.   
 
Not serious 
Serious  
Likely 
These risks are expected to occur in 
more than 20 out of 100 subjects. 
• 
 
• 
 
 
Not serious 
Serious 
Less likely  
These risks are expected to occur in 5-
20 subjects or less out of 100 subjects. 
• 
 
• 
 
 
 
Serious 
Rare  
These risks are expected to occur in 
less than 5 subjects out of 100  
 
• 
 
 


Form A 
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4.c. 
Study Intervention #1 
Rocuronium + neostigmine 
List each group exposed to this 
intervention on a separate line. 
(e.g., experimental, control, Arm A, Arm B, 
etc) 
Or state All Groups/Subjects 
For each group, list the benefits of this intervention.  (Benefits can be directly from 
the intervention or from a monitoring procedure likely to contribute to the subject’s 
well being).  If there are no benefits, state “none”. 
Group 2 (SUG) 
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 more beneficial in reducing post operative urinary retention.  
 
 
If you are requesting a Waiver of Informed Consent, complete the table below. 
 
If you have a consent form, list the reasonably foreseeable risks in the consent form (and do not complete this section).   
 
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious). 
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms) 
Do not delete frequency.  Frequency must be estimated because it will assist you with determining which adverse events will require 
prompt reporting.   
 
Not serious 
Serious  
Likely 
These risks are expected to occur in 
more than 20 out of 100 subjects. 
• 
 
• 
 
 
Not serious 
Serious 
Less likely  
These risks are expected to occur in 5-
20 subjects or less out of 100 subjects. 
• 
 
• 
 
 
 
Serious 
Rare  
These risks are expected to occur in 
less than 5 subjects out of 100  
 
• 
 
 
 
 


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4.d. List ALL other research procedures or components not listed in table 4.b. 
        The combination of Tables 4b and 4d should account for all of the research 
procedures that will take place during this study. 
 
Consider grouping similar procedures under a single component (e.g., blood work, CT = safety 
assessments) 
 
 
 
# 
Research component 
• 
individual 
procedures 
 
example: 
Eligibility Assessments 
• 
History and 
physical 
• 
Laboratory tests 
Add or delete rows as needed 
Column A 
Local Standard 
Practice Indicate the 
number of times each 
procedure will be 
performed as stipulated 
in the research plan that 
would be performed if 
the participant were not 
participating in the 
study. 
Column B 
Research Only  
Indicate the number of times 
each procedure will be 
performed solely for research 
purposes (meaning that the 
participant would not undergo 
the same number of 
procedures or would not 
undergo the procedure(s) at 
the same frequency if they 
were not participating in the 
study) 
Column D 
Risks 
If you are requesting a Waiver of Informed 
Consent, complete the table below. 
 
List the reasonably expected risks for each procedure 
or group of procedures under the following categories 
as appropriate: 
• Serious and likely; 
• Serious and less likely; 
• Serious and rare; 
• Not serious and likely; 
• Not serious and less likely 
1 
Research Component 
 
 
 
 
Intraoperative vitals 
Every 3 minutes 
 
Not serious and less likely 
 
PACU Bladder ultrasound 
 
1 
Not serious and less likely 
2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5.  Safety Precautions.  (Describe safeguards to address the serious risks listed above.) 
a.  Describe the procedures for protecting against or minimizing any potential risks for each of the more than minimal risk 
research procedures listed above. 
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 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, and 
headache. There is a 0.3% chance of an allergic reaction to sugammadex. 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 are randomized to sugammadex.  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.   


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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. 
 
b.  Where appropriate, discuss provisions for ensuring necessary medical or professional intervention in the event of adverse 
events, or unanticipated problems involving subjects. 
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 surgery.  
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. 
 
Blinding/Un-blinding: 
The patient and the postoperative evaluator will be blinded as to which reversal agent the patient receives. The anesthesia 
team taking care of the patient in the operating room will not be blinded, meaning they will know which reversal agent the patient 
receives. A member of the research team will provide the randomization envelopes to the anesthesia provider to open to 
determine which study group the patient has been assigned to. They will then contact IDS Pharmacy for the reversal drug, if 
necessary.  
 
c.  Will the safeguards be different between/among groups?   
 
Yes 
a 
No 
If yes, describe here 
 
 All literature references. 
 
1. 
Huang, L., et al., Risk factors for postoperative urinary retention in patients undergoing colorectal 
surgery: a systematic review and meta-analysis. Int J Colorectal Dis, 2022. 37(12): p. 2409-2420. 
2. 
Sivasankaran, M.V., T. Pham, and C.M. Divino, Incidence and risk factors for urinary retention 
following laparoscopic inguinal hernia repair. Am J Surg, 2014. 207(2): p. 288-92. 
3. 
Ziemba-Davis, M., et al., Identifiable Risk Factors to Minimize Postoperative Urinary Retention in 
Modern Outpatient Rapid Recovery Total Joint Arthroplasty. J Arthroplasty, 2019. 34(7S): p. S343-
S347. 
4. 
Mustonen, S., I. Ala-Houhala, and T.L. Tammela, Proteinuria and renal function during and after 
acute urinary retention. J Urol, 1999. 161(6): p. 1781-4; discussion 1784-5. 
5. 
Igawa, Y., J.J. Wyndaele, and O. Nishizawa, Catheterization: possible complications and their 
prevention and treatment. Int J Urol, 2008. 15(6): p. 481-5. 
6. 
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