Clinical trial NCT02860507
Conditions: Neuromuscular Blockade
Sponsor: University of South Florida
Start date: 2016-08-01; Completion date: 2018-02-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing deep neuromuscular blockaded (induced by rocuronium)

Detailed description:
Participants in the study group will receive a single bolus of Sugammadex (4.0mg/kg) prior to extubation. In the post-anesthesia care unit (PACU), a blinded safety-assessor will use the visual analog scale to clinically assess post-operative pain. Post-operative nausea and vomiting (PONV) will be assessed using a PONV rating scale every 30 minutes until PACU discharge. All patients will be monitored with continuous pulse-oximetry.

Arms: arm 1: Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv arm 2: Sugammadex 4mg/kg
Interventions: intervention 1: sugammadex intervention 2: Neostigmine intervention 3: Glycopyrrolate
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Prot_SAP_000.pdf: 
Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
Efficiency 
 
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A randomized, blinded-assessor, single center study to determine if administration of 
Sugammadex, when used to reverse deep neuromuscular blockade (NMB) after open 
or closed abdominal surgery, impacts hospital efficiency 
 
Study Site: 
Tampa General Hospital, Tampa, FL  
 
 
Principal Investigator: 
Name  
 
 
Enrico Camporesi, MD  
 
 
 
 
 
 
TeamHealth Anesthesia 
Address 
 
 
1 Tampa General Circle Suite A-327 
Address 
 
 
Tampa, FL 33606 
Telephone  
 
813-600-9094 
Fax 
 
 
        813-844-4467 
e-mail address        enrico_camporesi@teamhealth.com 
 
Co-Investigators 
Name:  
 
 
Devanand Mangar, MD 
 
e-mail:  
 
 
devanand_mangar@teamhealth.com 
 
 
Initial version: [01/23/15] 
Amended: 
[6/5/2015]  
Amended: 
[6/30/2015] 
Amended: 
[7/17/2015] 
Amended  
[10/5/2015] 
Amended  
[10/9/2015] 
Amended 
[12/18/15] 
Amended 
[02/22/16] 
Amended  
[6/01/16] 
Amended  
[08/02/16] 
Amended  
[9/12/16]


Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
Efficiency 
 
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Study Summary 
Title 
A, randomized, blinded-assessor, single center study to determine if 
administration of Sugammadex, when used to reverse deep 
neuromuscular blockade (NMB) after open or closed abdominal 
surgery, impacts hospital efficiency 
Short Title 
Deep NMB Reversal and Hospital Turnover Efficiency 
Protocol Number 
TGH015 
Phase 
Phase 4 
Methodology 
Randomized, blind-assessor, parallel, active control trial  
Study Duration 
12 months 
Study Center(s) 
Single-center (Tampa General Hospital, Tampa, FL) 
Objectives 
Primary Objective:  
To measure operating room (OR) turnover when using Sugammadex 
instead of combination of Neostigmine and Glycopyrrolate. 
 
Secondary Objectives:  
To evaluate the impact of reversal with 4.0 mg.kg-1 of Sugammadex 
after sustained deep neuromuscular blockade induced by rocuronium 
on patients reversal timing in comparison with standard reversal with 
Neostigmine 0.06 mg/kg and Glycopyrrolate 0.004mg/kg iv 
 
 To determine the incidence of side effects, including postoperative 
nausea and vomiting, post-operative pain, and post-operative 
complications  
Number of Subjects 
50 Patients (25/group) 
Diagnosis and Main 
Inclusion Criteria 
Open or Closed Ventral Hernia Repair or Open or Closed Colectomy 
Study Product, Dose, 
Route, Regimen 
Sugammadex 4.0 mg/kg iv, single bolus 
Neostigmine 0.06 mg/kg and Glycopyrolate 0.004mg/kg iv  
Duration of 
administration 
The bolus dose of Sugammadex will be administered within 1 minute 
into a fast running venous infusion. Sugammadex is dosed on the actual 
body weight of the subjects. 
Neostigmine plus Glycopyrrolate will also be injected over 1 minute. 
Reference therapy 
 
Statistical 
Methodology 
Analysis of Variance (ANOVA)  
Mixed Models 
Pearson Chi-squared/Fisher Exact Test 
 
 
 
 


Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
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A. Background/Rationale for Study 
 
In some patients, optimal clinical management requires continuing 
neuromuscular paralysis until conclusion of the surgical procedure. Reversal of residual 
neuromuscular paralysis at the end of a surgical procedure is an important step in 
reconstituting spontaneous muscle tone and re-establishing effective spontaneous 
ventilation and patient motility, cough effectiveness and natural muscular defenses. 
Slow reversal of muscle paralysis delays post-operative turnover time in the operating 
room (OR).   
The cholinesterase inhibitor neostigmine remains the most commonly used 
neuromuscular blocking agent antagonist, but neostigmine causes bradycardia, 
alteration of gastrointestinal motility and increased gastric secretions. Furthermore, 
neostigmine has a slow onset, and slow peak-effect, up to 10 to 15 min, and is thought 
to increase the risk of postoperative nausea and vomiting (PONV) [1,2], possibly by 
provoking gastric spasms. The frequent addition of atropine or glycopyrrolate to the 
neostigmine attenuates the onset of bradycardia, though the combination of 
neostigmine and atropine may be emetogenic [3]. Neostigmine alone in doses larger 
than 2.5 mg increases the incidence of PONV [4]. 
A newer reversal agent called Sugammadex is available in the United States and 
has previously been available in Europe and other countries. Sugammadex is a new 
selective relaxant-binding agent thathas a different mechanism of action from 
anticholinesterase neuromuscular antagonists, based on physico-chemical 
characteristics. Specifically, Sugammadex encapsulates in a rapid and selective way 
steroidal neuromuscular blocking agents, leading to ultra-rapid clearance of free 
neuromuscular agent from the tissues into plasma and rapid renal elimination, devoid of 
parasympathetic side-effects: nevertheless Sugammadex has been reported to cause 
other minor various side effects in less than 10% of patients, including mild headache, 
nausea, injection site irritation, dry mouth, fatigue, a cold sensation at the injection site, 
and oral discomfort [5-8]. Furthermore, the most common adverse effect of 
Sugammadex is also nausea [10]. A systematic review evaluating the use of 


Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
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Sugammadex instead of Neostigmine for reversal found Sugammadex to reduce all signs 
of residual postoperative paralysis. Furthermore, there were no differences observed in 
critical respiratory events, though this result was not statistically significant. 
Sugammadex was also noted to reduce drug-related side effects but no difference was 
noted in the rate of postoperative nausea or the rate of postoperative vomiting [10]. In 
summary, selective relaxant binding agent antagonism with Sugammadex speeds 
recovery of neuromuscular strength. Improvement to PONV compared with 
neostigmine and atropine might be small. There was also no benefit in terms of time to 
oral intake, recovery of gastrointestinal function, or ambulation [11]. Non-depolarizing 
neuromuscular blocking agents (ND-NMBAs) are used during general anesthesia to 
facilitate tracheal intubation and to optimize surgical conditions. However, due to the 
variability of their duration of action, residual effects of ND-NMBA can last longer than 
clinically necessary. 
Patients with large abdominal open wounds, such as patients requiring repair of 
large abdominal hernias or open colectomies, need profound neuromuscular relaxation 
during the crucial closure time, until the end of fascia closure, while the surgeon 
approximates the abdominal muscles or completes the fixation of fascial mesh insertion; 
conversely, the speed of recovery from neuromuscular blockade after the end of 
surgery is important to minimize delays to reach a steady spontaneous ventilation, 
extubation and a speedy recovery after the end of surgery. This group of patients is 
rapidly increase in number, both for the prevalence of obesity and of elderly patients, 
but also for the iatrogenic causes of multiple surgery with laparoscopy techniques 
operated in recent years, with exiting complications resulting in large abdominal 
hernias. 
There is a growing body of evidence  that postoperative residual neuromuscular 
blockade, defined as a train-of-four ratio (T4/T1) less than 0.9, places patients at higher 
perioperative risk for respiratory complications [12–14] and may increase hospital costs. 


Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
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In order to reduce or avoid postoperative residual paralysis, anesthesiologists typically 
monitor intraoperative neuromuscular transmission blockade and reverse residual 
neuromuscular blockade with acetylcholinesterase inhibitors.  
A recent publication (12) reported that the intraoperative use of ND-NMBA is 
associated with postoperative respiratory failure primarily due to pulmonary edema, 
pneumonia, and atelectasis. In addition, they observed that neostigmine reversal did 
not decrease the incidence of postoperative respiratory failure but was associated with 
a higher incidence of postoperative oxygen desaturation. However, in these patients 
who received neostigmine, qualitative neuromuscular transmission monitoring 
appeared to have a protective effect against hypoxia as the incidence of oxygen 
desaturation below 90% occurred less frequently when compared with those who 
received neostigmine without qualitative neuromuscular transmission monitoring. In 
this last study (12)  it was important to define efficiency of turn-over and recovery in 
PACU or in the OR.  PACU times were determined and documented by PACU nurses not 
involved with the study. PACU length of stay until discharge readiness was defined as 
time from PACU admission to the time the patient no longer required postoperative 
monitoring in the PACU. Actual PACU length of stay was defined as time from PACU 
admission until actual departure from the PACU. The occurrences of postoperative 
respiratory complications (i.e., atelectasis, pneumonia, and pulmonary edema) and 
mortality were retrieved from hospital billing data within 30 days after the index 
surgery. Reintubation was defined as the replacement of an endotracheal tube within 7 
days of the index procedure following initial extubation in the operating room. Any 
patient who required replacement of an endotracheal tube for a second surgical 
procedure was excluded. The secondary outcomes were postoperative hospital length 
of stay, incidence of postoperative atelectasis, and unplanned postoperative intensive 
care utilization including surgical intensive care unit, reintubation, and length of PACU 
admission until discharge and discharge readiness. Exploratory outcomes were related 
to signs and symptoms of postoperative respiratory failure including pneumonia, 
pulmonary edema, reintubation, and mortality. In this study, Neostigmine reversal did 


Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
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not affect oxygenation but was associated with increased atelectasis. Exploratory 
analysis revealed that high-dose neostigmine was associated with longer postoperative 
length of stay. Unwarranted use of neostigmine, and neostigmine administration 
without appropriate guidance from neuromuscular transmission monitoring, was 
associated with increased respiratory morbidity. Neostigmine is effective in reversing 
shallow and moderate nondepolarizing neuromuscular blockade [13] by inhibiting 
acetylcholinesterase [14] and increasing the amount of acetylcholine in the 
neuromuscular junction. [15] Neostigmine does not reverse deep neuromuscular 
blockade [16] and neostigmine should not be given to patients who present with deep 
neuromuscular blockade because it can result in incomplete reversal of neuromuscular 
blockade.  
We are advancing the hypothesis in this proposal,  that the administration of 
high-dose neostigmine could be associated with additional side effects in these patients 
who are reversed from deep levels of paralysis to awake, leading to greater utilization of 
hospital resources, and we believe that this association is due to the increased incidence 
of signs and symptoms of postoperative respiratory failure. We speculate that some of 
our anesthesia providers attempt to reverse deep neuromuscular blockade with a “full-
reversal” dose of neostigmine (heuristically 5 mg at our institution for a patient of 
average weight) and then transfer extubated and weak patients to the PACU. High-dose 
neostigmine was a strong predictor of atelectasis and was associated with longer 
postoperative hospital length of stay. Unwarranted use of neostigmine, and 
neostigmine administration without appropriate guidance from neuromuscular 
monitoring, was associated with increased respiratory morbidity. Our plan to administer 
Sugammadex to half of our study population to reverse neuromuscular blockade in 
these high-risk patients will allow us to determine if Sugammadex leads to better OR 
turnover, duration in PACU, and hospital utilization by inducing faster recovery and 
fewer side effects. 
 


Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
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Study Paradigm: we are planning to study the neuromuscular reversal process in 
patients who need open or closed abdominal wound closure of medium to large size: 
the surgical process benefits from and requires deep neuromuscular paralysis during 
abdominal muscle apposition and fascia closure, to result in a solid abdominal wall: we 
selected abdominal hernias and possibly open or closed abdomen colectomy, both 
groups of patients experiencing rather large wound closures. After completion of the 
muscular closure the superficial skin layers are completed quickly and anesthesia 
reversal, patient awakening and extubation will benefit from rapid reversal, restoration 
of spontaneous ventilation and reappearance of upper airway reflexes and strong cough 
responses. This will facilitate rapid transfer to PACU, turn-over in the OR and increase 
efficiency in this costly hospital area. The comparison will be between Sugammadex 
reversal vs. traditional Neostigmine/Glycopyrrolate reversal. 
 
B. Objectives 
Primary Objective: 
 
To measure operating room (OR) turnover when using Sugammadex instead of 
combination of Neostigmine and Glycopyrrolate. 
 
Primary Objective Endpoint:  
Time from injection of neuromuscular block reversal medication to start of next case 
(OR Turnover) 
 
 Primary Data Points: 
1. Time of operating room (OR) admission (physical placement of subject in 
the OR); 
2. Time of initial rocuronium dose and time of maintenance dose, if any; 
3. Time of sugammadex or neostigmine/glycopyrrolate administration; 
4. Time from sugammadex or neostigmine plus glycopyrolate 
administration to TOF of 0.9  
5. Time of extubation; 
6. Time of patient first eye opening, measured after question from provider 
7. Time of headlift, also measured from questions from provider 
8. Time of the end of surgery (end of skin suturing); 
9. Time of OR-discharge ready; 
10. Time of actual OR discharge; 
11. Time of post anesthesia care unit (PACU) admit; 


Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
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12. Time of PACU discharge ready 
13. Length of hospital stay 
 
   Secondary Objectives           
 
To evaluate the impact of reversal with 4.0 mg.kg-1 of Sugammadex after sustained 
deep neuromuscular blockade induced by rocuronium on patients reversal timing in 
comparison with standard reversal with Neostigmine 0.06 mg/kg and Glycopyrrolate 
0.004mg/kg iv 
 
To determine the Incidence of side effects, including postoperative nausea and 
vomiting, post-operative pain, and post-operative complications  
 
Secondary Endpoint: Time from PACU discharge to Discharge from hospital 
 
Secondary Data Points: 
1. 
Post-operative pain measured on the Visual Analog Scale (VAS) 0 – 10 
centimeter line.  
2. 
Total amount of required supplemental analgesia during the 
postoperative period for both treatment groups 
3. 
Post-operative complications 
 
Exploratory Objectives  
 To determine the Incidence of postoperative nausea and vomiting in both 
groups, to verify the superiority of Sugammadex reversal by adding  Apfel’s 
postoperative nausea and vomiting (PONV) risk factors assessment 
 
 
 
C. Methods 
 
Study Design 
This is a parallel, blinded-safety assessor, randomized, active control study.  
 
 
Inclusion/Exclusion Criteria 
Inclusion Criteria 
 
Patients scheduled for open or closed ventral hernia repair or open or 
closed colectomy 
 
ASA class I-III 
 
18 years and older 
 
Subjects with a Body Mass Index (BMI) of < 45 kg/m2 and weight less than 
150 kg 
 
Subjects who have given written informed consent 
 


Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
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Consent Process 
 
 
All patients that are scheduled to have an open or closed colectomy or ventral 
hernia repair will be evaluated for study eligibility in the preoperative assessment center 
at Tampa General Hospital during their visit with the anesthesiologist. The pre-operative 
assessment takes place 3-7 days prior to the scheduled surgery. Standard pre-operative 
orders include CBC, CMP, and PT/PTT.   Patients who qualify for the study and give 
informed consent will be entered into the study during their pre-operative visit or the 
patient may take the consent form home to review and sign on the day of surgery. All 
study discussions will take place in a private exam room in the preoperative clinic. All 
subjects will be given the opportunity to ask questions. If the investigator feels that the 
subject understands the research parameters and the subject is willing to sign the 
consent form, the patient will be enrolled in the study.  On the day of the surgical 
procedure, the study subject will present to the surgical prep unit.  It is here that the 
Exclusion criteria 
 
Subjects with medical conditions and/or undergoing surgical procedures 
that are not compatible with the use of the TOF-Watch® SX (e.g., injuries to 
the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with 
cardiac pacemaker 
 
Subjects known or suspected to have neuromuscular disorders impairing 
neuromuscular blockade (e.g., subjects with myasthenia gravis) 
 
Subjects known or suspected to have significant renal dysfunction (e.g. 
creatinine clearance < 30 mL.min-1 
 
Subjects known or suspected to have significant hepatic dysfunction 
 
Subjects known or suspected to have a (family)history of malignant 
hyperthermia; 
 
Subjects known or suspected to have an allergy to opiates/opioids, muscle 
relaxants or other medications used during general anesthesia; 
 
Subjects known or suspected to be hypersensitive to Sugammadex or other 
cyclodextrins or Rocuronium or any of its excipients 
 
Subjects who have a contraindication to, Rocuronium or Sugammadex 
 
Female subjects who are pregnant 
 
Morbidly obese subjects with a BMI > 45 kg/m2 or weight more than 150 
kg 


Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
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subject will be re-evaluated for willingness to participate.  Any additional questions will 
be answered prior to surgery.   
 
 
Screening & Baseline Visit: 
After the patient signs the consent form, patient demographics and medical 
history will be collected from the medical record.  A clinical examination, including vital 
signs (blood pressure, heart rate, and respiratory rate); physical measurements (body 
weight and body height) and a physical examination will be completed.  Patients will be 
assessed for postoperative nausea and vomiting (PONV) risk factors using the Apfel’s 
assessment.  All laboratory results will be reviewed to ensure that the patient meets the 
study criteria.  
 
After confirming that the patient meets the study criteria, the pharmacy will be 
notified by a member of the research team to start the randomization and drug 
preparation process.   
 
Stratification: 
The randomization procedure will minimize the imbalance between treatment arms 
within each of the following stratification factors: Age; <60 years and ≥60 years 
 
 
Randomization/ Blinding/ Unblinding 
 
A 1:1 computer-generated randomization schedule will be provided by the biostatistician 
and delivered to the research pharmacist. The research pharmacist will assign the patient 
to the next available treatment on the randomization list and prepare the study drug.  
Patients will be randomized to receive Sugammadex or neostigmine plus glycopyrrolate 
using a two-block design in which patients will be assigned to one of two groups. One 
group of 25 patients will receive Sugammadex and the second group of 25 patients will 
receive a combination of Neostigmine and Glycopyrrolate. Study personnel will provide 
the pharmacy with a copy of the signed informed consent and signed physician orders as 


Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
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well the patient’s actual body weight (ABW). In return, the pharmacist will prepare the 
study drug and provide the study staff with a red travel box that contains the study drug.  
The travel box is designed to maintain the blind.   The study medications will be 
delivered to the operating room by the study staff and will be administered to the 
patient by the anesthesiologist or CRNA assigned to the case.   
The operating room team, including the surgeon, nurses, anesthesiologist, nurse 
anesthetists and research coordinator will be blinded to the study drug. The research 
coordinator will be the post-operative assessor.    Each study drug will be administered 
intraoperatively as standard of care. Intraoperative notes in the electronic medical 
record (Epic) will be listed as ‘neostigmine plus glycopyrrolate/Sugammadex given so 
that the blinded assessor cannot view the study drug in the patient’s record. If 
necessary for the clinical management of the patient, the clinical team treating the 
patient can request un-blinding from the pharmacist. 
Table 2 Study Groups 
 
Preoperative Management The preoperative course will follow our standard of care 
practices  
Intraoperative Management:  The intraoperative course will follow our standard of care 
practices.  Doses/concentration of medications/agents used for the anesthetic 
management of the subjects enrolled in this trial may be adjusted when necessary to 
provide optimal subject care.  Anesthesia will be induced with propofol, intravenous 
opioids, and other medication(s)/agent(s) at a concentration range/dose(s) based on the 
clinical need of the subject. 
After induction of anesthesia but before administration of the intubation dose of 
Group Drug 
S 
Sugammadex 4mg/kg 
 
NG 
Neostigmine 0.06 mg/kg and Glycopyrrolate 0.004mg/kg iv 


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Rocuronium, continuous neuromuscular transmission monitoring will be performed 
using the TOF-Watch® SX until the end of anesthesia, at least until recovery of the T4/T1 
ratio to 0.9 and full recovery of neuromuscular function has occurred as determined by 
the anesthesiologist. The TOFWatch® SX will be affixed to the forearm/hand. 
Stabilization and calibration of the TOFWatch® SX will be done in the operating room.  
Rocuronium 0.6 mg/kg will be given intravenously to facilitate tracheal 
intubation; additional boluses of rocuronium, 0.15 mg/kg will be given to maintain 1-2 
twitches in response to supramaximal electrical stimulation of the ulnar nerve as 
determined by a TOF-Watch SX (Schering-Plough Ireland, Dublin, Ireland). In addition to 
the TOF-Watch-SX, depth of anesthesia will be measured with BIS-monitoring of all 
patients and a standard approaching 50% suppression will be maintained throughout 
the main duration of surgery. Reversal agent will be administered at a post-tetanic 
count of 1 or 2 (PTC 1,2 defined as deep block). 
Anesthesia will be maintained in both groups with intravenous opioids, propofol 
and/or medication(s)/agent(s), including inhalation anesthetic agents, at a 
concentration range/dose(s) based on the clinical need of the subject. 
Tracheal extubation will be performed at the end of anesthesia after 
administration of Sugammadex or neostigmine/glycopyrrolate and a T4/T1 ratio of 0.9 
has been measured by means of the TOF-Watch® SX.  After extubation, the investigator 
will determine when the subject is OR discharge ready (subject is extubated, wound 
dressing is in place, and vital signs are stable).   The actual time the subject was 
physically transferred from the OR to the PACU will also be recorded.  
 
Postoperative Management: Upon arrival in the PACU, the (sub)investigator (blinded 
safety-assessor), using the visual analog scale, will clinically assess post-operative pain.  
Assessment of patient pain levels involve a series of VAS testing postoperatively 
(upon arrival and every 30 minutes postoperatively until discharge from the PACU) using 
a 10 cm line.  Patients that complain of pain intensity >5 cm/10 cm, will be given a 
standardized rescue intravenous dilaudid regimen, IV dilaudid at 0.4mg  up to a max 


Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
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dose of 2mg prn q 2 hours or until a VAS of <5 is obtained. If a VAS score of <5 cannot be 
obtained, the PI may withdraw the patient from the study and administer another pain 
medication. Post-operative PACU narcotic consumption will be recorded and quantified.   
Post-operative nausea and vomiting (PONV) will be assessed using a PONV rating 
scale every 30 minutes until PACU discharge.  PONV will be rated as 0, no nausea; 1, 
mild nausea ≤ 15 minutes; 2, nausea ≥ 5 minutes and 3, vomiting.  PONV will be treated 
with ondanestron 4 mg intravenously and, if persistent, with metoclopramide 10 mg 
intravenously.    
All patients will be monitored with continuous pulse-oximetry. All post-operative 
complications will be captured.   
 
Follow-up Period: All patients will have a planned hospital admission from the PACU.  
Pain and PONV will be assessed every 2 hours for the first 24 hours followed by every 4 
hours until hospital discharge using the VAS scale.   All post-operative complications will 
be captured.  Post-PACU narcotic consumption will be recorded and quantified.  
 
CLINICAL MEASUREMENTS 
 
1. Hospital Efficiency: Time delay between injection of reversal drug (Sugammadex 
or Neostigmine and Glycopyrrolate) and time of extubation. 
 
 
2.  Analgesia quality and management:  Analysis of patient outcome will involve a 
series of Visual analog scale pain assessed both preoperatively and 
postoperatively. The participant’s pain level will then be assessed every 
30minutes in the post-anesthesia care unit (PACU) until the time of discharge 
using the Visual Analog Pain Scale. If a delay in transfer is observed, the reason 
for the delay will be noted.  
 
3. Supplemental Analgesics: Data involving the time to first intravenous dilaudid 
rescue and total dilaudid requirements will be obtained and recorded.  This data 
will be reviewed upon study completion. 
 
4. Post-operative adverse events: Analysis of adverse events will be measured to 
include: postoperative nausea and vomiting, constipation, respiratory 
depression, and sedation.  All side effects will be assessed based upon physical 
symptoms and clinical assessment.  This data will be reviewed upon study 


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completion. 
 
Duration of study participation 
The entire length of surgical procedure and length of hospital stay for each patient. The 
total study duration will be approximately 6 months from the start, in order to enroll the 
planned patients. 
 
 
 
Statistical Plan 
 
Sample Size 
As reported in a study by Della Rocca et al. (2013) **time from reversal administration 
to TOFr to 0.9 is significantly faster in the Sugammadex group than in the neostigmine 
group (deep block: 2.7 vs. 16.2 min, respectively; P < 0.0001). [17]. Based on data from 
this study published in Acta Scandinavica, the standard deviation for the primary 
outcome measure is assumed to be 18 min and in order to be able to detect a difference 
of 16 min between the treatment arm and control arm using t-test with alpha of 0.05 
and power of 80%, 21 patients are needed per study arm. To account for the possibility 
of not meeting the assumptions of t-test and the need of using non-parametric tests, 
this sample size is further adjusted to 25 per arm or 50 total according to the Pitman 
Asymptotic Relative Efficiency (ARE) method.  
 
 
Statistical Methods 
All data will be analyzed using Stata 11.0 (StataCorp LP, College Station, TX). Patients will 
be randomized to receive Sugammadex or Neostigmine/Glycopyrrolate for muscle 
paralysis reversal at a 1:1 ratio (25 patients will be in each arm). Before the start of the 
study, a sample of 50 sealed envelopes will be prepared by the biostatistician: 25 for the 
Sugammadex group and 25 for the Neostigmine/Glycopyrrolate group. Patients who 
meet the criteria for inclusion will be assigned to the next available subject number and 


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corresponding treatment as defined in the randomization envelope, in ascending 
sequence of subject numbers. Each subject number was only assigned once during the 
study. Only unblinded research staff will have access to the randomization process. 
Analysis of Variance (ANOVA) or mixed effects model will be used to analysis multiple 
VAS scores from the same patient. Categorical variables will be analyzed using either 
Chi-square or Fisher Exact tests.  Results will be expressed as mean ± SD (medians for 
nonparametric) for continuous variables and as frequencies and percentages for 
categorical variables.  A p value of <0.05 will be considered statistically significant. For 
secondary data points, post-operative pain, total amount of required supplemental 
analgesia during the postoperative period for both treatment groups, and post-
operative outcomes will be analyzed for covariance where the assigned treatment group 
will be the main predictor in the model. All statistical analyses and tests will be 
performed using SAS (v 9.1.1, Cary, NC). A two-sided P-value of <0.05 was considered 
statistically significant.  
 
Data Analysis 
We will perform a cost analysis to determine how changes in OR turnover time affect 
hospital costs and efficiency.  
 
Ethical Obligations 
Investigator Responsibilities 
 
 
The investigator is responsible for ensuring that the study is performed according to 
the IRB approved protocol, the Good Clinical Practice (GCP) guidelines, as well as any 
additional regulatory requirements.  The requirement of pre-study informed consent 
and following of guidelines will provide assurance that the patients’ rights and safety are 
protected. 
 
  
 
Informed Consent Process 
 
Each subject must provide written consent with full knowledge of the procedures 
involved with our research.  The informed consent, approved by the IRB and in 


Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
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accordance with regulatory guidelines, must be fully explained by the investigator or 
member of the study staff including the study aims, methods, benefits, and risks and 
signed by the subject before entry into the study.  The subjects will be informed that the 
study is voluntary and that they may withdraw at any time.  The subjects will be told 
that choosing against participation will not affect the care received for treatment.  The 
subjects will be informed that they will be authorizing access of investigational staff to 
confidential medical records.  The subject will be given sufficient time to read the 
consent and ask any questions.  Once the informed consent is signed, the subject will be 
given a copy of the document.  The subject will be given a second time to ask questions 
about the study on the day of their surgery while they are in the surgical prep unit and 
pre-operative area.   
 
 
Privacy of Records and Data 
 
All patients will be identified with a study number on clinical report forms provided 
by the pharmacy. Personal data of subjects used in the study will be limited to the 
necessary information needed. The collection of this data will be done in attempts to 
provide confidentiality and compliance with privacy protection regulations.  Consent will 
be obtained from the subject before the collection of data.  The data and subject 
identity will be kept confidential.  
 
 
 
 
Risk/Benefit: 
Risk to Participants 
There may be side effects to taking part in this study. 
Major side effects of sugammadex are: minor various side effects, including mild 
headache, nausea, the injection site irritation, dry mouth, fatigue, a cold sensation at 
the injection site, and oral discomfort 
 
Major side effects of neostigmine are: bradycardia, salivation, muscle twitching, bowel 
cramps, or diarrhea. 
 


Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
Efficiency 
 
17
17
Major side effect of glycopyrrolate are: dry mouth, vomiting; mild constipation; stuffy 
nose, sinus pain; or flushing (warmth, redness, or tingly feeling). 
 
 
Data safety monitoring plan 
All data will be monitored by the PI on a daily basis.  
 
Stopping Guidelines / Stopping Rules: Safety  
Termination may be recommended for any perceived safety concern based on clinical 
judgment, including but not limited to a higher than anticipated rate (≥1%) for any 
component resulting in an unexpected SAEs. 
 
Benefits to Participants 
 
The benefits of participating in this study may be faster recovery, less postoperative 
pain and less nausea and vomiting.  
 
Regulatory Documentation 
Documentation that must be available prior to the start of the study is as follows: 
 Copy of the IRB approval of the written protocol 
 Copy of approved protocol and amendments 
 Copy of the IRB approved informed consent 
 Regulatory correspondence and FDA IND documentation  
 Local regulatory documentation 
 Financial disclosure of investigators 
 Study and financial agreement  
 Curriculum vitae for each investigator 
 Verification of laboratory facility conducting experimental tests 
 
Data Monitoring and Records 
 
The primary investigator will monitor each individual CRF for completion and 
accuracy, as demonstrated by a provided signature following the review of each 
completed CRF. The investigator will maintain confidential individual records 
documented on CRFs for each subject.   
 
 
Case Report Form Completion 
 
CRFs must be completed for each subject.  All data collected must be collected and 
entered in a timely manner to reflect the most recent observations at any point.  
Subjective evaluations of each subject should be performed and entered by the same 
investigator when possible.   
 
 
 
 


Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
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18
18
Study Personnel and Responsibilities 
Enrico Camporesi, MD 
PI 
Responsible for all study 
related issues 
Devanand Mangar, MD, FFCP  
Co-PI 
Data collection and analysis 
Than Tran, MMS 
Biostatistician  
Data Analysis and 
Interpretation 
Prachiti Dalvi, MS    
Research 
Coordinator 
Data collection, Addresses IRB 
issues, communicates with IRB 
 
Conflict of Interest 
None 
 
D. References 
 
 [1] Turner DA, Smith G. Evaluation of the combined effects of atropine and neostigmine 
on the lower oesophageal sphincter. Br J Anaesth 1985;57: 956-9. 
[2] Proakis AG, Harris GB. Comparative penetration of glycopyrrolate and atropine 
across the blood-brain and placental barriers in anesthetized dogs. 
Anesthesiology 1978;48: 339-44. 
[3] Chhibber AK, Lustik SJ, Thakur R, FranciscoDR, Fickling KB. Effects of anticholinergics 
on postoperative vomiting, recovery, and hospital stay in children undergoing 
tonsillectomy with or without adenoidectomy. Anesthesiology 1999;90:697-700. 
[4] Tramer MR, Fuchs-Buder T. Omitting antagonism of neuromuscular block: effect on 
postoperative nausea and vomiting and risk of residual paralysis: a systematic 
review. Br J Anaesth 1999;82:379-86. 
[5] Cheng CR, Sessler DI, Apfel CC. Does neostigmine administration produce a clinically 
important increase in postoperative nausea and vomiting? Anesth Analg 
2005;101(5):1349-55. 


Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
Efficiency 
 
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19
[6] Naguib M, Brull SJ. Update on neuromuscular pharmacology. Curr Opin Anaesthesiol 
2009;22:483-90. 
[7] Puhringer F, Rex C, Sielenkamper A, Claudius C, Larsen P, Prins M, Eikermann M, 
Khuenl-Brady K, Chhibber AK, Lustik SJ, Thakur R, Francisco DR, Fickling KB. 
Reversal of profound, high-dose rocuronium-induced neuromuscular blockade 
by sugammadex at twodifferent time points. Anesthesiology 2008;109:188-97. 
[8] Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JHM, Hermens Y, 
Mirakhur RK. Reversal of rocuronium induced neuromuscular blockade with 
sugammadex in pediatric and adult surgical patients. Anesthesiology 
2009;110:284-94. 
[9] Hemmerling TM, Zaouter C, Geldner G, Nauheimer D. Sugammadex —a short review 
and clinical recommendations for the cardiac anesthesiologist. Ann Card Anaesth 
2010;13(3):206-16. 
[10]  Abad-Gurumeta AA, Ripolles-Melchor J, Casans-Frances R, Espinosa A, Martinex-
Hurtado E, Fernandex-Perex C, Ramirez JM, Lopez-Timoneda F, Calvo-Vecino JM. 
A systematic review of sugammadex vs neostigmine for reversal of 
neuromuscular blockade. Anaesthesia 2015; 70: 1441-1452.  
[11] Koyuncu O, Turhanoglu S, Ozbakis Akkurt C, Karcıoglu M, Ozkan M, Ozer C, Sessler 
DI, Turan A. Comparison of sugammadex and conventional reversal on 
postoperative nausea and vomiting: a randomized, blinded trial.  J Clin Anesth. 
2014 Dec 24.  


Clinical Research Protocol #TGH015: Deep NMB Reversal and Hospital Turnover 
Efficiency 
 
20
20
[12] Sasaki N et al Effects of neostigmine reversal of nondepolarizing neuromuscular 
blocking agents on postoperative respiratory outcomes: a prospective study.. 
Anesthesiology. (2014)  959-968 
[13] 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; 107:130–7 
[14] Herbstreit F, Peters J, Eikermann M: Impaired upper airway integrity by residual 
neuromuscular 
blockade: 
Increased 
airway 
collapsibility 
and 
blunted 
genioglossus muscle activity in response to negative pharyngeal pressure. Anes 
thesio log y 2009; 110:1253–60 
[15] Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Nisman 
M: Intraoperative acceleromyographic monitoring reduces the risk of residual 
neuromuscular blockade and adverse respiratory events in the postanesthesia 
care unit. Anes thesio log y 2008; 109:389–98 
[16] Butterly A, Bittner EA, George E, Sandberg WS, Eikermann M, Schmidt U: 
Postoperative residual curarization from intermediate-acting neuromuscular 
blocking agents delays recovery room discharge. Br J Anaesth 2010; 105:304–9 
[17]  Della Rocca G, Pompei L, Pagan DE Paganis C, Tesoro S, Mendola C, Boninsegni 
P, Tempia A, Manstretta S, Zamidei L, Gratarola A, Murabito P, Fuggiano L, DI 
Marco P. Reversal of rocuronium induced neuromuscular block with 
sugammadex or neostigmine: a large observational study. Acta Anaesthesiol 
Scand. 2013 Oct;57(9):1138-45. 

ICF_001.pdf: 
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CONSENT TO BE IN A RESEARCH STUDY 
 
TITLE:  
A phase IV randomized, blinded-assessor, single center study to 
determine if administration of Sugammadex, when used to reverse 
deep neuromuscular blockade after open abdominal surgery, impacts 
hospital efficiency 
  
 
 
 
PROTOCOL #:  
 
TGH015 
 
NCT #:  
 
 
NCT02860507  
 
 
 
SPONSOR: 
 
 
TeamHealth 
 
 
 
 
265 Brookview Centre Way 
 
 
 
 
Suite 400 
 
 
 
 
Knoxville, TN 37919 
 
 
 
 
  
SITE(S):  
 
 
Tampa General Hospital 
 
1 Tampa General Circle 
 
Tampa, Florida 33606 
 
United States 
 
 
 
 
FUNDED IN PART BY: 
Merck  
 
Global Center for Scientific Affairs/Merck Research Laboratories 
UG2CD-30, 351 N Sumneytown Pike 
North Wales, Pennsylvania 19454 
 
 
 
 
INVESTIGATOR: 
Enrico Camporesi, MD 
 
A327 
 
1 Tampa General Circle 
 
Tampa, Florida 33606 
 
United States 
 
 
STUDY-RELATED  
PHONE NUMBER(S): 
 
PI - Enrico Camporesi, MD: (813) 600-9094 (24 hours) 
 
 
 
 
 
 


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INTRODUCTION  
 
The anesthesia group at Tampa General Hospital (TGH) is a part of TeamHealth Anesthesia, a nationwide 
clinical group. We are conducting a clinical study (a type of research study). This consent form provides 
information on the procedures and risks involved in this clinical study. Please read this form carefully so 
that you can decide if you want to take part in the study. If you join this study, you can still stop at any 
time.  
 
You may want to talk to your family, friends, or primary care doctor before making your decision.  
 
Please ask the study doctor about any questions that you may have about this study. If you do not take 
part in this study it will not affect your continued medical treatment.  
 
You can find information about this research study at http://www.ClinicalTrials.gov , as required by U.S. 
law. This website will not show any information that can identify you. At most, the website will 
summarize the results of the study. You can search this website at any time.  
 
PURPOSE OF THE STUDY 
 
For your operation, you will be given a drug called rocuronium to make sure you do not move during 
surgery. At the end of your surgery, doctors give you a combination of  two drugs (Neostigmine and 
Glycopyrrolate) to allow you to move again. More recently, a new drug (Sugammadex) was approved by 
the United States Food and Drug Administration to restore muscle movement at the end of surgery. 
Sugammadex has been on the European market for several years. 
 
In this study, we would like to find out which drug (Neostigmine and Glycopyrrolate versus 
Sugammadex) restores muscle function faster.  
 
You are being asked to be a part of the study because you will be having a particular type of surgery. You 
will be given all required medicines and treatment regardless of whether you decide to participate in the 
study or not.  
 
DESCRIPTION OF THE STUDY 
 
In this study, you will be randomly assigned to receive one of the two medications that are given as a 
part of your medical treatment  to allow you to regain muscle movement after surgery (Neostigmine 
and Glycopyrrolate OR Sugammadex). After your operation, you will be given one of the drug 
treatments intravenously. We will collect data on the amount of time needed for your muscles to begin 
working again  and keep track of any side effects you experience. This data will be analyzed to compare 
the two drugs. 
 
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY? 
 
A total of 50 people at Tampa General Hospital will participate in this study.HOW LONG WILL I BE 
IN THIS STUDY? 


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If you meet the conditions to be a part of this study, you will be a part of the study for the entire length 
of your surgical procedure and for the length of your stay at the hospital. You can leave the study at any 
time you want to without losing any of your rights to current or future medical care at the hospital. If 
you decide to leave the study, we hope you will talk to the study staff to learn about any possible health 
or safety consequences.     
 
WHAT WILL HAPPEN TO ME? 
 
If you decide to participate in this study, you begin by signing this form which is your consent to take 
part in the research. This form is also your agreement to allow us to use your personal health 
information as needed in the research study. Until you have agreed to take part in the study and have 
signed this form, no research or measures will take place.  
 
In order to perform surgery on you, you will be given rocuronium to paralyze your muscles for the 
duration of the surgery; this is a standard practice. At the end of the procedure, you will be given either 
a drug combination (Neostigmine and Glycopyrrolate) or the study drug (Sugammadex) to reverse 
muscle paralysis. Regardless of which treatment group you are assigned to, you will be regularly 
monitored. Your doctor and the research coordinator will be aware of whether you received the drug 
combination or the study drug; however, the individual who is assessing your side effects will not be 
aware of what drug treatment you received. This process is called blinding and helps us ensure that we 
collect and evaluate the data without any favoring one drug treatment over the other.  
 
CAN ANYTHING HAPPEN TO ME? WHAT ARE THE RISKS? 
 
As with any drugs, Neostigmine, Glycopyrrolate, and Sugammadex have side effects.  
 
Major side effects of Sugammadex are mild headaches, nausea, irritation at the injection site, dry 
mouth, fatigue, cold sensation at the injection site, and oral discomfort.  
 
Major side effects of Neostigmine are bradycardia (slower heart rate), salivation, muscle twitching, 
bowel cramps, or diarrhea.  
 
Major side effects of Glycopyrrolate are dry mouth, vomiting, mild constipation, stuffy nose, sinus pain, 
or flushing (warmth, redness, or a tingly feeling).  
 
WILL I BENEFIT FROM THIS RESEARCH? 
 
If you agree to participate in this study, you may or may not receive any medical benefit. We do not 
know which drug treatment (Neostigmine and Glycopyrrolate OR Sugammadex) is better to reverse 
muscle paralysis. That is why we are doing this study.  
 
Although you may not receive any benefit from participating in this study, medical science and future 
patients may benefit from your participation. 
 
WILL I GET PAID? 
 


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We will not pay you for the time you volunteer while being in this study. 
 
WILL IT COST ANYTHING TO BE IN THE STUDY? 
 
It will not cost you anything to be part of the study. The costs of the study drug Sugammadex or 
standard medication of Neostigmine and Glycopyrrolate will be covered by research funds. All other 
charges will be the responsibility of you or your insurance company because you would receive these as 
part of your regular medical care. These are costs that are considered medically reasonable and 
necessary and would be part of the care you would receive if you did not take part in this study. 
However, you may want to check with your insurer to see if they will cover these costs.   
 
WHAT OTHER TREATMENT CHOICES ARE THERE? 
 
Muscle paralysis reversal is a necessary part of surgery. If you choose not to participate in the study, you 
will be given the drug combination of Neostigmine and Glycopyrrolate since this is a standard practice in 
surgery.  
 
If you choose not to take part in this study, your care will not change in any way. Your doctor will still do 
his/her best to make sure that you get all of the normal care that he/she gives to surgical patients. Your 
choice not to be a part of the study will not be written in your medical records. 
 
WHAT ARE MY RIGHTS AS A RESEARCH STUDY PARTICIPANT? 
 
Taking part in this study is voluntary. You may decide not to take part or you may leave the study at any 
time. Not taking part or leaving the study will not lead to any penalty or loss of the benefits that you 
should normally have. If you decide to stop being a part of the study, we hope you will talk to your study 
doctor or study staff first to learn about any possible health or safety consequences.  
 
However, your study doctor, your local institution and the sponsor of this study, have the right to stop 
you from being a part of the study, or cancel the study, without your consent at any time for any of the 
following reasons: 
 
if it is in your best interest; 
 
you do not consent to continue the study after being told of changes in the research that may 
affect you; 
 
or for any other reason 
 
NEW FINDINGS 
 
You will be given any new information we learn about that might change your choice to keep being a 
part of the study. 
 
WHAT HAPPENS IF I GET HURT IN THE STUDY? 
 
If you need emergency care: 


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 
Go to your nearest hospital or emergency room right away. Call 911 for help. It is important that 
you tell the doctors at the hospital or emergency room that you are participating in a research 
study. If possible, take a copy of this consent form with you when you go.  
 
Call the study doctors as soon as you can. They will need to know that you are hurt or ill. Call Dr. 
Enrico M. Camporesi at 813-600-9094 or Prachiti Dalvi at 863-513-9885.  
If you do NOT need emergency care: 
 
Go to your regular doctor. It is important that you tell your regular doctor that you are 
participating in a research study. If possible, take a copy of this consent form with you when you 
go.  
 
If you believe you have been hurt or if you get sick because of something that is done during the study, 
you should call Dr. Enrico M. Camporesi at 813-600-9094 immediately.  
 
Processes and procedures regarding human research are in place to help prevent any injuries during the 
course of studies. Should you believe, however, that you have been hurt or if you get sick because of 
something that is done during the study, you should call Dr. Enrico M. Camporesi at 813-600-9094.   
 
ADULT TAMPA GENERAL HOSPITAL INJURY STATEMENT 
 
In the event you suffer an injury or illness as a result of participating in this research study, please be 
aware that immediate, short-term medical treatment for the injuries or illness will be available to you 
from Tampa General Hospital.  The cost of the medical treatment will be billed to you to the extent not 
covered by your insurance company or government program or the study sponsor.  No other 
compensation will be offered.  You are not giving up any legal rights by signing this form.  If you believe 
you have experienced a reaction to the study drug/device or have been injured as a result of research 
procedures performed at Tampa General Hospital, please contact the Department of Risk Management 
at (813) 844-7666. 
 
Be aware that your health care payer might not cover the costs of study-related injuries or illnesses 
when an investigational treatment is being used. 
 
 
WILL THE HOSPITAL, STUDY DOCTOR, OR MERCK BENEFIT FROM THIS STUDY? 
 
Your doctor’s practice will be compensated for their efforts to conduct this study by Merck. However, 
the researchers do not hold a direct financial interest in the sponsor or the product being studied. The 
sponsor is compensating Tampa General Hospital for storing and dispensing both drug treatments. 
 
AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH INFORMATION 
(HIPAA LANGUAGE) 
 
The federal privacy regulations of the Health Insurance Portability & Accountability Act (HIPAA) protect 
your identifiable health information. By signing this form, you are permitting FGTBA of TeamHealth to 
use your health information for research purposes. You are also allowing us to share your health 
information with individuals and organizations other than FGTBA of TeamHealth who are also involved 
in the research and listed below. 
 


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In addition, the following groups of people may also be able to see your health information and may use 
that information to conduct this research: 
 
The medical staff that takes care of you and those who are part of this research study; 
 
The research site for this study, Tampa General Hospital; 
 
Any laboratories, pharmacies, or others who are part of the approved plan for this study; 
 
All designated review committees such as Data and Safety Monitoring Board, Tampa General 
Hospital Feasibility Committee/Office of Clinical Research  
 
Data Safety Monitoring Boards or others who monitor the data and safety of the study 
 
There may be other people and/or organizations who may be given access to your personal 
health information, including Tampa General Hospital; 
 
Federal offices such as the Food and Drug Administration (FDA) and Health Canada that protect 
research subjects like you 
 
Individuals at the Western Institutional Review Board 
 
The study doctor and the team of researchers 
 
Merck, who is paying for this research study. 
 
Anyone listed above may use consultants in this research study, and may share your information with 
them. If you have questions about who they are, you should ask the study team. Individuals who receive 
your health information for this research study may not be required by the HIPAA Privacy Rule to 
protect it and may share your information with others without your permission. They can only do so if 
permitted by law. If your information is shared, it may no longer be protected by the HIPAA Privacy Rule. 
 
By signing this form, you are giving your permission to use and/or share your health information as 
described in this document. As part of this research, FGTBA of TeamHealth and Tampa General Hospital 
may collect, use, and share the following information: 
 
Your research record 
 
All of your past, current or future medical and other health records held by FGBTA of 
TeamHealth, Tampa General Hospital, other healthcare providers or any other site affiliated 
with this study as they relate to this research project. This may include, but is not limited to 
records related to HIV/AIDS, mental health, substance abuse, and/or genetic information. 
 
By signing this form, you are permitting FGBTA of TeamHealth and Tampa General Hospital to receive, 
use, and share personal health information collected about you for research purposes within Tampa 
General Hospital health care system.  You are also allowing Tampa General Hospital to share your 
personal health information with other individuals or organizations who are also involved in this 
research. 
 
This authorization will never expire unless and until you revoke it. 
 
VOLUNTARY PARTICIPATION/RIGHT TO WITHDRAW FROM THE STUDY 
 
When you sign this consent and authorization form, you authorize or give permission for the use of your 
health information as described in the consent form. You can revoke or take away your authorization to 
use and disclose your health information at any time. You do this by sending a written notice to the 
investigator in charge of the study at the following address: 
 
Principal Investigator: Dr. Enrico M. Camporesi  


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For IRB Study # 
1 Tampa General Circle, Suite A-327 
Tampa, FL 33606 
 
If you withdraw your authorization, you will not be able to be in this study. If you withdraw your 
authorization, no new health information that identifies you will be gathered after that date. Your 
health information that has already been gathered may still be used and disclosed to others. This would 
be done if it were necessary for the research to be reliable. You will not have access to your health 
information that is included in the research study records until the end of the study.  
 
EMERGENCY AND IRB CONTACT 
 
You have the right to ask questions about the known and unknown risks of this study at any time.  
 
The study doctor will be available and on-call during the whole study. Please call the study doctor (Dr. 
Enrico M. Camporesi) at 813-600-9094 if: 
 
You have any questions about the study 
 
You experience a study-related injury 
 
You have a medical emergency 
 
Contact information for Tampa General Hospital, the site of this research is as follows: 
Tampa General Hospital 
P.O. Box 1289 
Tampa, FL 33601 
813-844-7000 
 
This study has been reviewed by an IRB and the FDA, meaning that the study was deemed ethically 
sound to conduct.  
 
If you have any questions about your rights or related concerns as a research subject, or if you have 
questions, concerns, or complaints about the research, you may contact  
 
IRB Name: 
 
Western Institutional Review Board (WIRB) 
Address: 
 
1019 39th Avenue SE, Suite 120 
City, State, Zip:  
Puyallup, WA 98374-2115 
Phone:  
 
1-800-562-4789 or 360-252-2500 
E-mail:   
 
Help@wirb.com  
 
Western Institutional Review Board (WIRB) is a group of people who perform independent review of 
research.  
 
Western Institutional Review Board will not be able to answer some study-specific questions, such as 
questions about appointment times. However, you may contact Western Institutional Review Board if 
the research staff cannot be reached or if you wish to talk to someone other than the research staff. 
 
Review and approval of this study by the Western Institutional Review Board is not an endorsement of 
the study or is outcome.  


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Do not sign this consent form unless you have had a chance to ask questions and have received 
satisfactory answers to all of your questions.  
 
If you agree to be in this study, you will be given a copy of this signed and dated consent form.  
 
SIGNATURES 
 
I agree to take part in this study. I authorize the use and disclosure of my health information as 
described in this consent and authorization form. I have had the chance to ask questions about being in 
this study and have those questions answered. By signing this consent and authorization form, I am not 
releasing or agreeing to release the investigator, the sponsor, the institution, or its agents from liability 
for negligence.  
 
_____________________________________________________________________________________ 
Printed Name of Subject   
 
________________________________________________________        _________________________ 
Signature of Subject   
 
 
 
 
 
 
   Date 
 
STATEMENT OF PERSON CONDUCTING INFORMED CONSENT DISCUSSION 
 
I have fully explained the procedures involved in this study, identifying those that are investigational, 
and have explained their purpose. I have asked whether or not any questions have arisen regarding the 
investigational procedure and have answered those questions to the best of my ability.  
 
_____________________________________________________________________________________ 
Printed Name of Person Conducting Informed Consent Discussion    
 
________________________________________________________        _________________________ 
Signature of Person Conducting Informed Consent Discussion 
 
   Date