Effectiveness of Sugammadex Versus Neostigmine on Neuromuscular Reversal in Pediatric Patients Undergoing Laparoscopic Appendectomy for Acute Appendicitis: A Randomized Controlled Trial
Phase: PHASE4
Conditions: Appendicitis, Surgery
Sponsor: Emory University

 
 
 
 
 
 
 
 
Effectiveness of Sugammadex versus Neostigmine on neuromuscular 
reversal in pediatric patients undergoing laparoscopic appendectomy 
for acute appendicitis: A Randomized Controlled Trial 
STUDY00003913 
 
Date: September 25, 2024 
NCT05256901 

Protocol Title: Effectiveness of Sugammadex vs. Neostigmine on neuromuscular reversal in pediatric 
patients undergoing laparoscopic appendectomy for acute appendicitis : A Randomized Controlled Trial
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PROTOCOL TITLE:   
Effectiveness of Sugammadex versus Neostigmine on neuromuscular reversal in pediatric 
patients undergoing laparoscopic appendectomy for acute appendicitis: A Randomized 
Controlled Trial
EXTERNAL (NON-EMORY) COLLABORATORS                                                                   
Children’s Healthcare of Atlanta
PRINCIPAL INVESTIGATOR:
Name 
, MD
Department Anesthesia
Telephone Number: 
Email Address 
VERSION: 3:25SEP2024
FUNDING SOURCE: MERCK SHARP & DOHME CORP. 

Protocol Title: Effectiveness of Sugammadex vs. Neostigmine on neuromuscular reversal in pediatric 
patients undergoing laparoscopic appendectomy for acute appendicitis : A Randomized Controlled Trial
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REVISION HISTORY
No need to review this section if this is the first version of the protocol you are submitting to the IRB
Revision #
Version 
Date
Summary of Changes

Protocol Title: Effectiveness of Sugammadex vs. Neostigmine on neuromuscular reversal in pediatric 
patients undergoing laparoscopic appendectomy for acute appendicitis : A Randomized Controlled Trial
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Table of Contents
1.
Study Summary....................................................................................................................4
2.
Objectives ............................................................................................................................5
3.
Background..........................................................................................................................5
4.
Study Endpoints...................................................................................................................6
5.
Study Intervention/Investigational Agent ...........................................................................7
6.
Procedures Involved ............................................................................................................7
7.
Statistical Analysis Plan........................................................................................................8
8.
Sharing of Results with Participants ....................................................................................8
9.
Study Timelines....................................................................................................................9
10.
Inclusion and Exclusion Criteria...........................................................................................9
11.
Vulnerable Populations .......................................................................................................9
12.
Local Number of Participants ..............................................................................................9
13.
Recruitment Methods..........................................................................................................9
14.
Withdrawal of Participants................................................................................................10
15.
Risk to Participants ............................................................................................................10
16.
Potential Benefits to Participants......................................................................................10
17.
Compensation to Participants ...........................................................................................11
18.
Data Management and Confidentiality .............................................................................11
19.
Data Montoring and Participants Safety ...........................................................................11
20.
Provisions to Protect the Privacy Interest of Participants .................................................13
21.
Economic Burden to Participants ......................................................................................13
22.
Informed Consent..............................................................................................................14
23.
Setting................................................................................................................................14
24.
Resources Available...........................................................................................................15
25.
References.........................................................................................................................16
26.      Protocol Checklist………………………………………………………………………………………………………….17

Protocol Title: Effectiveness of Sugammadex vs. Neostigmine on neuromuscular reversal in pediatric 
patients undergoing laparoscopic appendectomy for acute appendicitis : A Randomized Controlled Trial
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1. Study Summary
Project Title
Effectiveness of Sugammadex vs. Neostigmine on 
neuromuscular reversal in pediatric patients 
undergoing laparoscopic appendectomy for acute 
appendicitis: A randomized cotrolled trial
Project Design
This study is designed as a randomized controlled trial 
with patients assigned to neuromuscular reversal with 
either sugammadex or neostigmine/glycopyrrolate 
reversal. The study will not be blinded to the 
anesthesiologist to allow for appropriate decision 
making on timing and dosage of reversal. This is a 
single center study. They will be assigned by a 
computerized random number generator.
Primary Objective
To determine if the utilization of sugammadex versus 
neostigmine for neuromuscular reversal in pediatric 
patients affects efficiency as measured by time from 
surgery end to out of the operating room (OR)
Secondary Objective(s)
To determine the effects of sugammadex on:

Return to bowel functon

Time to tolerance of an oral diet

The association of using Sugammadex on 
exposure to inhalational anesthesia

Length of hospital stay

Post-Anesthsia Care Unit (PACU) length-of-stay
Research 
Intervention(s)/Interactions
Suggamadex or Neostigmine for reversal of 
neuromuscular blockade
Study Population
Patients of Children’s Healthcare of Atlanta
Sample Size
120
Study Duration for 
individual participants
  1.25 years
Study Specific 
Abbreviations/ Definitions 
TO4 – Train of Four 
RSI- Rapid Sequence Induction
PACU- Post Anesthesia Care Unit
Funding Source (if any)
Merck Sharpe & Dohme Corp.

Protocol Title: Effectiveness of Sugammadex vs. Neostigmine on neuromuscular reversal in pediatric 
patients undergoing laparoscopic appendectomy for acute appendicitis : A Randomized Controlled Trial
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2. Objectives
Primary: 
To determine which of the two neuromuscular reversal agents: Sugammadex or Neostigmine 
among pediatric patients undergoing laparscopic appendectomy-- affects efficiency as 
measured by end-time of surgery until exit of operating room (OR). 
Secondary: 
To determine effect of Sugammadex: on return of bowel function, time to tolerance of an oral 
diet. 
To determine if the utilization of Sugammadex affects: hospital length of stay, post-anesthesia 
care unit (PACU) length of stay. 
To determine the association of using Sugammadex on exposure to inhalational anesthesia. 
Hypothesis: We hypothesize that utilizing sugammadex in comparison to neostigmine for 
neuromuscular reversal in pediatric patients undergoing laparoscopic appendectomy will result 
in improved efficiency demonstrated by decreased time from surgery end to out of the OR. 
Furthermore, we predict utilizing sugammadex in comparison to neostigmine for 
neuromuscular reversal will result in a quicker return to first bowel movement. 
We hypothesize that utilizing sugammadex in comparison to neostigmine for neuromuscular 
reversal in pediatric patients undergoing laparoscopic appendectomy for acute appendicitis will 
result in a faster time to tolerance of an oral diet. 
 We also anticipate that the use of Sugammadex over Neostigmine, will be correlated with a 
decreased exposure to volatile anesthesia as measured by the average inspired sevoflurane 
concentration from surgery start to finish.
3. Background
Patients presenting to the operating room for laparoscopic appendectomy with a diagnosis of 
acute appendicitis require rapid sequence induction (RSI) due to significant vomiting and 
concern for increased gastric content. For this reason succinylcholine—accompanied by 
neostigmine—is predominately used in adults for RSI to prevent potential aspiration. 
Unfortunately, in pediatric patients there are many concerns about the use of succinylcholine, 
including complications such as bradycardia, hyperkalemia, dysrhythmias and cardiac arrest 
from undiagnosed skeletal muscle myopathy. For many anesthesiologists, these concerns 
prompt the decision to use a non-depolarizing muscle relaxant such as rocuronium for 
induction. However, if the standard RSI dose is used, it often results in residual paralysis at the 
end of short procedures such as laparoscopic appendectomies. It has recently been 
demonstrated that prolonged paralysis is prevalent even at low doses of rocuronium in 
pediatric patients. For these reasons, it is imperative to find a way to provide adequate and safe 

Protocol Title: Effectiveness of Sugammadex vs. Neostigmine on neuromuscular reversal in pediatric 
patients undergoing laparoscopic appendectomy for acute appendicitis : A Randomized Controlled Trial
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RSI conditions for intubation, appropriate muscle relaxation for laparoscopic procedures and 
the ability to quickly reverse neuromuscular blockade in this pediatric population. Sugammadex 
has the potential to allow for the utilization of an appropriate RSI dose of rocuronium for 
intubation, as it provides the ability to reverse neuromuscular blockade earlier than the 
neostigmine reversal, which is currently the standard of care. Retrospective reviews have 
shown the use of Sugammadex in pediatric patients to be safe and effective. However, there 
has not been prospective data about the effect on operating room efficiency on brief pediatric 
procedures such as laparoscopic appendectomies—one of the most common urgent pediatric 
surgeries performed. There are numerous other potential benefits of using sugammadex over 
typical reversal including quicker return of bowel function, faster time to tolerance of an oral 
diet and decreased exposure to volatile anesthesia. The return of bowel function is particularly 
important in pediatric patients undergoing laparoscopic procedures. We hypothesize that the 
utilization of sugammadex in pediatrics results in a quicker return to bowel function. This has 
previously been demonstrated in adults, but data is lacking in the pediatric population. We also 
hypothesize that patients receiving sugammadex versus neostigmine reversal will have an 
improved time to tolerance of an oral diet, which may impact wound healing and nutrition. As 
anesthesiologists often under dose rocuronium in these short procedures, due to lack of quick 
reversal options, high levels of volatile anesthesia are utilized to compensate for inadequate 
muscle relaxation. With the use of sugammadex allowing for proper muscle relaxation 
throughout the entire case, we hypothesize that patients will have a lower total volatile 
anesthetic exposure during the procedure. This is exceedingly important in pediatric 
anesthesia, where the detrimental effects of volatile anesthetics on the developing brain have 
been demonstrated in numerous animal studies.
4. Study Endpoints
Improved efficiency demonstrated by decrease time from suregery end to to out-of the 
operating room: use of rocuronium with anticholinesterase reversal is associated with a 5-
minute increase in surgery end to out of OR time relative to Neostigmine/Succinylcholine (18 
minutes vs 13 minutes, respectively). We expect the Sugammadex cohort to mirror the 
Neostigmine/Succinylcholine group. In order to show a mean difference of 5 minutes between 
the two groups with standard deviation of 7.5 minutes, an alpha error of 5% and a beta error of 
5%, 60 patients will be needed in each cohort to power the study appropriately.
Lower total volatile anesthetic exposure: as sevoflurane is the only volatile anesthetic 
administered during this procedure, a calculation of average sevoflurane at 5 minute 
increments multiplied by the time of exposure will be used. The total time of exposure will be 
determined by the presence of end tidal sevoflurane in the anesthetic record.
The primary variable of time from surgery end to out of the OR will be evaluated via the 
Epic computer chart after discharge from the hospital. The secondary variables, including time 
to first bowel movement, time to tolerance of an oral diet, total inhalational anesthesia 

Protocol Title: Effectiveness of Sugammadex vs. Neostigmine on neuromuscular reversal in pediatric 
patients undergoing laparoscopic appendectomy for acute appendicitis : A Randomized Controlled Trial
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exposure, PACU length of stay and hospital length of stay will be evaluated via the Epic 
computer record after discharge from the hospital.
5. Study Intervention/Investigational Agent 
Study drug provided by the sponsor will be kept and stored at the Children’s Healthcare of 
Atlanta pharmacy. Eligible participants that have been consented will be randomized by a 
member of the study team. The unblinded anesthesiologist will obtain the randomized drug 
from the pharmacy and administer the reversal agent. 
The research pharmacy at Children’s Healthcare of Atlanta will be responsible for dispensing 
the study medication, Sugammadex. Approximately 60 patients will be randomized to receive 
Sugammadex. The research pharmacy will require 51 2mL vials and 9 5mL vials of sugammadex. 
There will be no blinding of the medication by pharmacy.
The dose administered by the anesthesiologist is determined by patient weight: 2mg/kg is 
recommended if spontaneous recovery has reached the reappearance of the second twitch in 
response to TOF stimulation; 4mg/kg is the maximum dose allowable. 
We will be using Sugammadex for it’s FDA approved indication, and FDA indicated age 
range. However, our standard of care reversal agent is Neostigmine/Glycopyrrolate. Due to the 
cost differential between Sugammadex and Neostigmine, our pharmacy keeps Sugammadex 
stored away, which requires a member of the anesthesia team to go to the pharmacy to obtain 
medication. Since Neostigmine is readily available in the OR, Sugammadex is used if we are 
concerned about the reversability of our patient. There are other large pediatric hospitals 
throughout the country who have changed to use Sugammadex as their standard of care for 
children 2-17 years of age.
6. Procedures Involved

Participants meeting the inclusion criteria will be identified via Epic on the surgery 
status board. 

A member of the study team will approach a potential participant to obtain consent.

Once consented, a study team member will randomize the patient usong the 
computerized RedCap database prior to their scheduled surgery. 

The patient will be randomized to 1 of 2 arms: Sugammadex (Arm 1), or Neostigmine 
(Arm 2).

The research pharmacy at Children’s will dispense the drug to the unblinded 
anesthesiologist.

Induction of anesthesia will include the administration of Rocuronium, as the standard 
dosing by anesthesiologists at our institution (0.6-1.2 mg/kg), so as not to influence the 
normal practice. 

Neuromuscular relaxation will be checked and documented after intubation and at 15-
minute intervals during the procedure utilizing qualitative TOF monitoring.

At surgery closing, the anesthesiologist will again evaluate the qualitative TO4 
measurement. 

Protocol Title: Effectiveness of Sugammadex vs. Neostigmine on neuromuscular reversal in pediatric 
patients undergoing laparoscopic appendectomy for acute appendicitis : A Randomized Controlled Trial
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
The reversal agent, Sugammadex or Neostigmine, will be administered at the start of 
closure.

If sugammadex is the randomized reversal drug, the dose will be 4mg/kg for a TOF 0-
1and a post-tetanic count greater than or equal to 1, and 2mg/kg for a TOF 2 or greater.

If Neostigmine/Glycopyrrolate is the randomized reversal drug, 0.07mg/kg of 
Neostigmine and 0.01mg/kg of will be administered once at least two twitches are 
present.

A final qualitative TOF will be documented immediately prior to extubation.

A Case Report Form will be used to fill out data pertinent to the study from the 
Anesthesia Report.

Data from nursing documentation will be evaluated to determine return of bowel 
function and time to tolerance of an oral diet.

The anesthetic record will be used to determine medications administered, evaluate 
hemodynamic changes and calculate volatile anesthetic exposure.

The hospital record will  be used to obtain: time from surgery end to out-of the OR, 
PACU length of stay and hospital length of stay.

Study data will be evaluated by the primary investigator(s). The information will not be 
blinded to investigators.

Once patient is discharged from hospital, there will be no follow-up by the study team.
7. Statistical Analysis Plan
All statistical analyses will be performed using R statistical software (version 4.1.1). Univariate 
associations between the outcomes and the primary exposure will be determined statistically 
with either Fisher’s exact test or Wilcoxon rank sum test, as determined by the distributions. If 
differences occur in demographic, preoperative, and/or intraoperative variables between the 
two cohorts, multivariable regressions with those variables will be included as explanatory 
variables (in addition to the exposure) in order to limit confounding. A two-sided p-value of 
<0.05 will be considered statistically significant throughout.
Although the randomization should limit any bias from the effects of external factors, there 
is still a small chance of confounding that can occur randomly. In order to minimize bias, these 
external factors (e.g. preoperative midazolam administration, intraoperative propofol dose, 
intraoperative dexmedetomidine dose, and trainee vs anesthetist staff) will be collected for 
each patient and compared between the two cohorts. Any differences in these external factors 
will be controlled out using linear regression.
8. Sharing of Results with Participants
Participants of this study will be blinded to the neuromuscular reversal agent they are 
randomized to at the time of their procedure. Once patient is billed for anesthesia services, 
they will be unblinded to which neuromuscular blockade they were given. We will not be 
sharing study results with patients. 

Protocol Title: Effectiveness of Sugammadex vs. Neostigmine on neuromuscular reversal in pediatric 
patients undergoing laparoscopic appendectomy for acute appendicitis : A Randomized Controlled Trial
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9. Study Timelines

The study subject will participate for one day.

Patient will be approached for consent after their surgery for laparoscopic 
appendectomy has been posted on the status board. 

During surgery, pertinent study data, including dosage of randomized drug and any 
adverse events, if applicable, will be notated. 

There will be no follow-up with patient from study team after the patient is discharged.

The estimated date of study completion is: 01/01/2026. 
10. Inclusion and Exclusion Criteria
              Inclusion Criteria

Patients 2-17 years of age. 

Diagnosis of acute appendicitis

Patient undergoing laparoscopic appendectomy at Children’s Healthcare of Atlanta.

Parent or Legal Authorized Representative willing to participate, able to understand and 
sign informed consent 
 Exclusion Criteria

Patient with an allergy to Sugammadex or Neostigmine

History of renal dysfunction

Parent or legal guardian unwilling or unable to understand the informed consent

Females that are pregnant or nursing
11. Vulnerable Populations
Patients that are cognitively impaired will be approached to participate in the study, so long as 
the child’s legal guardian displays knowledge and agrees to study consent and procedures.  
12. Local Number of Participants
We predict a total of 150 patients will be screened; we will recruit 120 participants at Children’s 
Health campus for this study. Because there is no predominance of laparascopic appendectomy 
among male or female, we anticipate the number of male/female subjects should be fairly 
equal. 
13. Recruitment Methods

Both the Principal Investigator and study staff will take initiative to search for potential 
study candidates on Epic. 

Potential patients will be identified on Epic via surgery status board. Patients diagnosed 
with acute appendicitis, who are undergoing a laparascopic appendectomy will be 
approached by study staff prior to their procedure.

Protocol Title: Effectiveness of Sugammadex vs. Neostigmine on neuromuscular reversal in pediatric 
patients undergoing laparoscopic appendectomy for acute appendicitis : A Randomized Controlled Trial
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
No flyers, advertisements or social media/online recruitment mechanisms will be used 
to recruit patients. 
14. Withdrawal of Participants
Parents or Legal Authorized Representative may withdrawal participant from study without 
penalty at any given time.  
A participant may be withdrawn from study if their surgery is scheduled after hours, or if they 
do not receive paralytic. 
Principal Investigator may withdrawal subject at her discretion as deemed fit for patient safety.
15. Risk to Participants
Sugammadex

Hypersensitivity: The most common hypersensitivity adverse reactions are nausea, 
pruritus and urticaria. More severe hypersensitivity reactions such as anaphylaxis are 
rare and in clinical studies, occurred in 0.3% of patients.

Decreased effectiveness of hormonal contraceptives. If a hormonal contraceptive is 
used an additional, non-hormonal contraceptive method or back-op method of 
contraception for the next 7 days is recommended. (Sugammdex educational handout 
created by CHOA will be provided to patients taking hormonal contraceptives). 

Bradycardia. Rare instances of significant bradycardia requiring treatment with 
medication

Anaphylaxis
Neostigmine/Glycopyrrolate:

Gastrointestinal distress. The most common reactions are nausea, vomiting, 
diarrhea and abdominal cramps.

Increased secretions. Neostigmine commonly increases salivation and mucus 
membrane production. It can also increase lacrimation.

Bradycardia. Significant bradycardia is commonly seen following neostigmine 
administration, so it is regularly administered with glycopyrrolate to prevent this 
reaction.

Anaphylaxis
16. Potential Benefits to Participants
If patient is randomized to Neostigmine/Glycopyrrolate, the participant will receive the 
standard of care; thus, no potentential benefits  are anticipated. 
However, if the participant is randomized to Sugammadex, we anticipate the patient will:

Have quicker return to bowel function

Have faster time to tolerance of an oral diet

Have decreased exposure to volatile anesthesia 

Protocol Title: Effectiveness of Sugammadex vs. Neostigmine on neuromuscular reversal in pediatric 
patients undergoing laparoscopic appendectomy for acute appendicitis : A Randomized Controlled Trial
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
Have a shorter PACU length-of-stay

Have a decreased hospital length-of-stay
17. Compensation to Participants
Participants will not be reimbursed for their involvement in the study.
18. Data Management and Confidentiality
Data regarding the administration of neuromuscular blocking agents, reversal method, time 
spent in PACU will be collected. Demographic and procedural data will also be collected for 
each study participant including: age, weight, sex. All data will be entered into a secure RedCAP 
database. Data will be stored on a secure server that is password protected with access to 
study personnel only.
If a participant declines to participate in the study, the participant will not be assigned a 
study ID number and the study coordinators will not collect any data on the participant. If the 
participant agrees to participate in the study, the participant will be assigned a study ID number 
and the study coordinators will collect data points pertinent to the study. These procedures will 
help prevent unauthorized inclusion of the patient’s data in the RedCap database.
19. Data Monitoring and Participants Safety
Monitoring of Adverse Events (AEs) and Serious Adverse Events (SAEs) will be performed on a 
case-by-case basis. Standard operating procedures and safety measures will apply in the 
operating room during procedure and administration of neuromuscular reversal  agent. 
Following procedure, the principal investigator or research coordinator will review medical 
record and communicate with PACU post-operatively to follow-up with patient care and 
recovery status of the patient. A Case Report Form will be completed by a study member to 
assess post-operative recovery parameters and data points. The principal investigator will 
determine the seriousness of adverse events and whether the event was related to the study. 
Serious adverse events (life-threatening, requiring intervention) will be reported to the sponsor 
and IRB according to sponsor/IRB standards.
   Emory’s self-monitoring tool will be used to ensure all requirements are met throughout the 
duration of the study.
DSMP Requirement
How this Requirement is Met 
Frequency
Responsible Party(ies)
Real-time review of 
participant data during 
initial data collection.
Completion of Case Report Form
Expectation is that 
this happens every 
time you obtain 
information.
Principal Investigator; 
Research Coordinator
Site Monitoring at pre-
determined intervals: 
The Principal Investigator 
has a responsibility to 
Sponsor will perform 
Monitoring visits at their 
discretion
at least every six 
months while 
participants are 
Research Coordinator 
will use Self-
Monitoring Tool to 
ensure study is 

Protocol Title: Effectiveness of Sugammadex vs. Neostigmine on neuromuscular reversal in pediatric 
patients undergoing laparoscopic appendectomy for acute appendicitis : A Randomized Controlled Trial
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ensure that the study is 
following all aspects of 
the protocol. 
Monitoring visits will be 
reported to IRB
receiving 
intervention 
annually while 
participants are in 
follow-up
compliant with IRB 
standards.
Principal Investigator 
will review and sign.
100% review of 
regulatory files
ensuring regulatory 
documentation requirements 
are met by the IRB at study 
start-up and close-out
Initial and close-
out visits
Research coordinator
100% review of consent 
forms
Documentation of ICF in Epic via 
research note
Each time consent 
is obtained
Principal Investigator; 
Research Coordinator
Review of credentials, 
training records, the 
delegation of 
responsibility logs (if 
applicable)
All training certificates, 
delegation logs, etc. will be filed 
and kept up to date in 
regulatory binder.
Periodically, as 
needed
Research Coordinator
Comparison of case 
report forms (CRF) to 
source documentation 
for accuracy and 
completion
Review medical record and 
compare to Case Report Form, 
communicate with PACU to 
obtain additional necessary data 
points
Following 
participant 
procedure
Principal Investigator; 
Research Coordinator
Review of 
documentation of all 
adverse events
Identification of adverse events 
via medical record and CRF. 
A Note to File will 
be created and 
signed by PI after 
an adverse event is 
identified. 
Required 
IRB/sponsor 
reporting will 
apply. 
Principal Investigator,
Research coordinator
Monitoring of critical 
data points (eligibility, 
study endpoints, etc.)
Collection of data points will be 
logged on Case Report Form, 
eligibility will be assessed by PI 
after a patient has met inclusion 
criteria. 
CRF to be 
completed after 
each procedure; 
eligibility status will 
be marked on 
Enrollment Log
Principal Investigator;
Research Coordinator
Laboratory review of 
processing and storage 
of specimens
No labs will be collected,
 N/A
N/A
N/A

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patients undergoing laparoscopic appendectomy for acute appendicitis : A Randomized Controlled Trial
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Assessment of laboratory 
specimens stored locally
N/A
N/A
N/A
Test article 
accountability review
The sponsor/manufacturer of 
Sugammadex (Merck) will 
provide the study drug. The 
study drug will be stored 
properly and dispensed by 
CHOA IDS. 
Lot numbers will be 
recorded in CRF 
after drug is 
dispensed
Merck,
CHOA research 
pharmacy
Accountability logs, 
dispensing records, and 
other participant records 
 Dispensing records/ Lot# of 
study drug will be kept in 
Subject/Enrollment binder
Study drug/ lot 
numbers will be 
filed after each 
procedure for 
enrolled patient.
Research Coordinator
For FDA regulated 
studies, the following 
requirements apply:
Timing, frequency, 
and intensity of 
monitoring
Monitoring methods 
(may include centralized, 
on-site, and self-
assessment)
On-Site monitoring visits will be 
performed by sponsor.
Self-Monitoring Assessment will 
be performed annually
Sponsor on-site 
visits (at their 
discretion)
Annual (Self-
Monitoring)
Sponsor (On-Site) 
PI/ Research 
Coordinator (Self-
Assessment)
*For international studies, you are required to engage a CRO that is working in the site country and/or to 
consult with Emory’s legal counsel regarding compliance with the country’s clinical research regulations.
20. Provisions to Protect the Privacy Interest of Participants
Potential participants will be approached for consent in a private area/room to discuss 
study procedures. Participants will have ample time to ask any questions during consent 
process; they will be reminded that their participation in the study is voluntary, and they will 
not be penalized if they choose not to participate in the study. Participant discussion and data 
will be limited to study personnel only.
   Emory’s self-monitoring tool will be used to ensure all regulatory requirements are met 
throughout the duration of the study.
21. Economic Burden to Participants
Participants will not incur any additional charges related to the study. If a patient is randomized 
to Arm 1: Sugammadex, the study drug, will be provided by the sponsor. For patients 
randomized to Arm 2, the standard of care will apply and Neostigmine will be billed to the 
patient’s insurance. 

Protocol Title: Effectiveness of Sugammadex vs. Neostigmine on neuromuscular reversal in pediatric 
patients undergoing laparoscopic appendectomy for acute appendicitis : A Randomized Controlled Trial
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22. Informed Consent 

Prospective participants will be approached once their surgery for laparascopic 
appendectomy is posted on surgery status board.

Assent will be obtained from participants 6-17 years of age. 

If a participant has a cognitive disability, assent will not be required; the participants’ 
parent or legal guardian will consent on behalf of the child. 

Consent will be obtained in a private area, with only patient, legal guardian and 
member(s) of study staff present.  

For this study, informed consent will be obtained one time on the day of-- or within 24 
hours of surgery. 

Informed consent will be obtained by a parent or legal aurthorized representative after           
discussion with a study member. 

We will allow ample time time discuss informed consent and answer any questions the 
partiipant/legal guardian may have. 

Legal guardian and patients of age to assent, will be informed that their decision to 
participate is completely voluntary.

Informed consent will be obtained by both parents if present. 

If only one parent is present, consent will be obtained-- even if the other parent is alive, 
known, competent, reasonably available, and shares legal responsibility for the care and 
custody of the child.
Non-English-Speaking Participants  

Spanish-speaking patients and their legal guardian will be approached for this study, 
either by a Spanish-speaking member of the study team or an interpreter. 

A short-form consent will be used to obtain Informed Consent. 

Informed consent will be obtained by both parents if present. 

If only one parent is present, consent will be obtained-- even if the other parent is alive, 
known, competent, reasonably available, and shares legal responsibility for the care and 
custody of the child.
23. Setting

The research team will identify patients at Children’s Healthcare of Atlanta, that 
meet the inclusion criteria via Epic by viewing surgery status board. 

The CHOA pharmacy will prepare study drug provided by the sponsor after patient is 
ramdomized.

The study drug will be administered in the operating room, the patient will be 
followed in the PACU for collection of study data points.

Once the patient has been discharged from the hospital, there will be no follow-up 
by the study team and no additional data will be collected. 

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24. Resources Available
Laparascopic appendectomies are posted almost daily on the surgery status board. The 
inclusion criteria is fairly broad, which will present more opportunities for patient recruitment. 
Since laparascopic appendectomies are one of the most common urgent pediatric procedures, 
we plan to recruit 120 patients by the anticipated study end date.
All study staff have completed the required CITI training and understand their duties and 
role in the study. Knowledge of the protocol and study procedures will be reviewed with study 
members prior to patient recruitment; this will ensure patients are screened, consented, and 
monitored appropriately.

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25. References
1. Tran, D.T.T., et al., Rocuronium vs. succinylcholine for rapid sequence intubation: a 
Cochrane systematic review. Anaesthesia, 2017. 72(6): p. 765-777.  
2. Rawicz, M., B.W. Brandom, and A. Wolf, The place of suxamethonium in pediatric 
anesthesia. Paediatr Anaesth, 2009. 19(6): p. 561-70. 
3. Magorian, T., K.B. Flannery, and R.D. Miller, Comparison of rocuronium, succinylcholine, 
and vecuronium for rapid-sequence induction of anesthesia in adult patients. 
Anesthesiology, 1993. 79(5): p. 913-8.  
4. Gilbertson LE, Fiedorek MC, Fiedorek CS, Trinh TA, Lam H, Austin TM. Prolonged 
neuromuscular block after rocuronium administration in laparoscopic pyloromyotomy 
patients: A retrospective bayesian regression analysis. Paediatr Anaesth. 2021 
Mar;31(3):290-297.
5. Tobias JD. Current evidence for the use of sugammadex in children. Paediatr Anaesth. 
2017 Feb;27(2):118-125. doi: 10.1111/pan.13050. Epub 2016 Nov 17. Erratum in: 
Paediatr Anaesth. 2017 Jul;27(7):781.
6. JM. Effects on Postoperative Gastrointestinal Motility After Neuromuscular Blockade 
Reversal With Sugammadex Versus Neostigmine/Glycopyrrolate in Colorectal Surgery 
Patients. Ann Pharmacother. 2020 Dec;54(12):1165-1174.
7. Loepke AW, Istaphanous GK, McAuliffe JJ 3rd, et al. The effects of neonatal isoflurane 
exposure in mice on brain cell viability, adult behavior, learning, and memory. Anesth 
Analg 2009;108:90-104.
8. Head BP, Patel HH, Niesman IR, Drummond JC, Roth DM, Patel PM. Inhibition of p75 
neurotrophin receptor attenuates isoflurane-mediated neuronal apoptosis in the 
neonatal central nervous system. Anesthesiology. 2009;110:813–825.
9. Ghazal E, Amin A, Wu A, Felema B, Applegate RL. Impact of rocuronium vs 
succinylcholine neuromuscular blocking drug choice for laparoscopic pyloromyotomy: is 
there a difference in time to transport to recovery?. Pediatric Anesthesia. 2013 
Apr;23(4):316-21.

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26. Protocol Checklist
Please note that protocol sections with an asterisk (*) should always be included in the protocol; if the section does not 
have an asterisk, and you have not included the section in the protocol, the IRB will consider it your attestation that 
the section does not apply to your study.
Protocol Section
Added to 
the 
protocol?
External Collaborators- if applicable, add each external collaborator information and 
indicate whether that institution’s IRB will review (or has already reviewed) that individual’s 
engagement in human participants research activities)  
☐ Yes
   n/a
Funding Source*: Include the information for the funding entity for this study.  Please 
explain if this study is covered by a sub-award or other pertinent information. Say 
“department” if you do not have any other funding.
☒ Yes
Objectives*: Describe the purpose, specific aims, or objectives and state the hypotheses to 
be tested
☒ Yes
Background*: Describe the relevant prior experience and gaps in current knowledge. 
Describe any relevant preliminary data. Provide the scientific or scholarly background for, 
the rationale for, and significance of the research based on the existing literature and how 
will it add to existing knowledge
☒ Yes
Study Endpoints*: Describe the primary and secondary study endpoints. Describe any 
primary or secondary safety endpoints. 
☒ Yes
Study Intervention/Investigational Agent*: Describe the study intervention and/or 
investigational agent (e.g., drug, device) that is being evaluated.  
☒ Yes
Drug/Device Handling: If the research involves drugs or devices, describe your plans to store,
handle, and administer those drugs or devices so that they will be used only on participants 
and be used only by authorized investigators.
If using a drug, explain if the control of the drug is managed by IDS (or VA/Grady/CHOA 
research pharmacies). If not, provide IDS exemption document.
If a device, explain how the device is being stored and managed.
☒ Yes
If the drug is under an FDA REMS, plan to complete the REMS checklist found here, on the 
IRB website.
☒ Yes
If the drug is considered a controlled substance, make sure you have filled out this form.
☐ Yes
  n/a

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If applicable, identify the holder of the IND/IDE/Abbreviated IDE. An Emory investigator who 
holds an IND or IDE is considered to be a Sponsor-Investigator (S-I). If the study is under an S-I, 
review this section of our website for additional requirements.
☒ Yes
Procedures involved*: Describe and explain the study design and include a study schema.  
Describe all research procedures being performed and when they are performed, including 
procedures being performed to monitor participants for safety or minimize risks
☒ Yes
Procedures-Minimizing risk*: describe the procedures performed to lessen the probability 
or magnitude of risks.
☒ Yes
Procedures- Drug/Device Use: describe all drugs and devices used in the research and the 
purpose of their use and their regulatory approval status
☒ Yes
Procedures-Source Records*: describe source records that will be used to collect data about 
participants. Attach all surveys, scripts, and data collection forms to the submission.
☒ Yes
Procedures-Data collection*: describe what data will be collected during the study and how 
that data will be obtained
☒ Yes
Procedures- Long Term Follow Up*: once all research-related procedures are complete, 
what data will be collected during this period.  If no data is collected after procedures are 
completed, please state in the submission.
☒ Yes
Data and Specimen Banking: describe where the specimens will be stored, how long they 
will be stored, how the specimens will be accessed, and who will have access to the 
specimens.  Depending on the volume and nature of the collection, this may require a 
separate repository-specific IRB submission. The VA Data Repository SOP is required if the 
study is creating a data repository at the Atlanta VA.
List the data to be stored or associated with each specimen.
Describe the procedures to release data or specimens, including the process to request a 
release, approvals required for release, who can obtain data or specimens, and the data to 
be provided with specimens.
☐ Yes
  n/a
Sharing of Results with Participants*: Describe whether results (study results or individual 
subject results, such as results of investigational diagnostic tests, genetic tests, or incidental 
findings) will be shared with participants or others (e.g., the participant’s primary care 
physicians) and if so, describe how the results will be shared If applicable (e.g. for studies 
involving scans and/or panels of exploratory testing on specimens)
☒ Yes

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Plan for managing the types of findings that might arise. This should include any secondary 
findings that are being sought actively, findings that might be anticipatable, and findings 
that might be un-anticipatable. 
Plan for recognizing, analyzing, and handling incidental findings and how incidental findings 
will be communicated to participants during the consent process. If the plan is not to 
disclose any findings, then this should be included. This plan might include the option for 
participants to opt-out of receiving incidental findings.
Description of the research team’s responsibilities following disclosure of a finding. This 
should detail educational information about the nature of the finding, how to seek care 
from a clinician or specialist, obtaining health insurance to secure treatment, and/or referral 
to a clinical specialist, if one is required. 
Reminder to include language in the consent form to let the participants know your plans 
for this – see Modular Language for Informed Consent Forms on IRB website)
Study timelines*: describe the duration of an individual participant’s participation in the 
study; anticipated time to enroll all study participants and the estimated date for the 
investigators to complete this study (complete primary analyses)
☒ Yes
Inclusion and Exclusion Criteria*: describe how individuals will be screened for eligibility 
and the criteria that define who will be included or excluded in your final study sample 
☒ Yes
Population*: describe the study popualation and indicate specifically whether you will 
include or exclude each of the following special populations: 

Adults unable to consent

Individuals who are not yet adults (infants, children, teenagers)

Pregnant women

Prisoners
Note: you cannot exclude people with limited English proficiency unless you can 
demonstrate the scientific need for such exclusion.
Community Participation: For studies aimed at addressing issues that affect a certain 
community or group: How, if at all, will this study involve people from the target community 
in the design of the study? Conduct of the study? How will the results of the research be 
shared with the participants and/or the target community/ies?  
If studying Race or Ethnicity, have you defined these terms, and explained their proposed 
mechanism of action if these characteristics will be used in an explanatory model?
☒ Yes

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Research with pregnant women, fetuses, or neonates: review this checklist to verify you 
have provided enough information to ensure the safety and well-being of this population.
☐ Yes
  n/a
Research with neonates of uncertain viability: review this checklist to verify you have 
provided enough information to ensure the safety and well-being of this population.
☐ Yes
    n/a
Research involving prisoners: review this checklist to verify you have provided enough 
information to ensure the safety and well-being of this population.
☐ Yes
    n/a
Research involving children: review this checklist to verify you have provided enough 
information to ensure the safety and well-being of this population.
☒ Yes
Research involving cognitively impaired adults: review this checklist to verify you have 
provided enough information to ensure the safety and well-being of this population.
☐ Yes
    n/a
Research involving economically or educationally disadvantaged persons: describe the 
additional safeguards that have been included in the study to protect the rights and welfare 
of these subjects
☐ Yes
   n/a
Local Number of Participants*: Indicate the total number of participants to be accrued 
locally. If applicable, distinguish between the number of participants who are expected to 
be enrolled and screened, and the number of participants needed to complete the research 
procedures (i.e., numbers of participants excluding screen failures.) 
Provide your projected enrolling goals, including the percentage of participants according to 
sex and race.   
☒ Yes
Recruitment Methods*: Describe when, where, and how potential participants will be 
recruited.  Describe the source of participants. Describe the methods that will be used to 
identify potential participants.  Describe materials that will be used to recruit participants. 
Attach copies of these documents with the application. 
If including advertisements, attach the final copy of them. When advertisements are taped 
for broadcast, attach the final audio/videotape. You may submit the wording of the 
advertisement before taping to preclude re-taping because of inappropriate wording, 
provided the IRB reviews the final audio/videotape. Describe the amount and timing of any 
payments to participants. Reimbursement for expenses/travel?
If using contests or raffles as incentive, you must offer entry to all potential participants, not 
just those who enroll in the study/complete study-related procedures, per Georgia State 
Law.
☒ Yes

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All research recruitment through social media needs to follow this guidance, which does not 
allow the use of personal social media accounts for some recruitment activities.
Withdrawal of Participants*: Describe anticipated circumstances under which participants 
will be withdrawn from the research without their consent. Describe any procedures for 
orderly termination. Describe procedures that will be followed when participants withdraw 
from the research, including partial withdrawal from procedures with continued data 
collection.
☒ Yes
Risk to Participants*: List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the participants related to the participant's participation in the research. 
Include as may be useful for the IRB’s consideration, a description of the probability, 
magnitude, duration, and reversibility of the risks. Consider physical, psychological, social, 
legal, and economic risks.
If applicable, indicate which procedures may have risks to the participants that are currently 
unforeseeable.
If applicable, indicate which procedures may have risks to an embryo or fetus should the 
subject be or become pregnant.
If applicable, describe risks to others who are not participants.
☒ Yes
Potential Benefits to Participants*: Describe the potential benefits that individual 
participants may experience from taking part in the research. Include as may be useful for 
the IRB’s consideration, the probability, magnitude, and duration of the potential benefits.
Indicate if there is no direct benefit. Do not include benefits to society or others.
☒ Yes
Compensation to Participants*: Describe if/how subjects will be compensated for 
participation in this study. Indicate what method compensation will be delivered (e.g. cash, 
gift card, school credit). Describe the amount and timing of any payments to participants.  
How much?  What kind?  Is tax information required? (if so, must be reflected in the 
informed consent form). Will payments be pro-rated if a participant withdraws early?
☒ Yes
Data Management and Confidentiality*: Describe the data analysis plan, including any 
statistical procedures or power analysis. Describe the steps that will be taken to secure the 
data (e.g., training, authorization of access, password protection, encryption, physical 
controls, certificates of confidentiality, and separation of identifiers and data) during 
storage, use, and transmission. Describe any procedures that will be used for the quality 
control of collected data. 
☒ Yes
Describe how data or specimens will be handled study-wide*: What information will be 
included in that data or associated with the specimens?
☒ Yes

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•
Where and how data or specimens will be stored?
•
How long the data or specimens will be stored?
•
Who will have access to the data or specimens?
•
Who is responsible for receipt or transmission of the data or specimens?
•
How data or specimens will be transported?
Data Monitoring and Participants Safety (if this study is more than minimal risk, this 
section is required): 
Ensure that you review our Data and Safety Monitoring plan guidance for specific details 
about this section, and examples of what the IRB will be requiring according to the level of 
risk.
If a DSMB is needed, please describe the composition of the board (if not already detailed 
in the protocol).  Review this guidance for more information.  If the sponsor protocol does 
not contain all required information, please in this section. 
Describe the plan to periodically monitor the data at the site level according to risk level. 
Include the appropriate completed monitoring table, if applicable. 
Description of the plan for notifying the IRB of reportable events, whether the sponsor 
requires reporting above and beyond the Emory IRB reporting requirements, and if so, a 
description of the requirements and plan for meeting them. 
Please address the specific details below. If deemed not applicable, please provide 
rationale:
Subject safety:

Specific subject safety parameters 

Frequency of subject safety observations

Individual responsible for safety monitoring

Subject stopping rules – under what conditions will a subject be removed from 
study participation and who will make the decision?

Study stopping rules - under what conditions will the study be modified or stopped 
and who will make the decision?

Reporting mechanisms (i.e. Deviations, adverse events, UPs)
Data Integrity:

Specific data elements to be reviewed

Frequency of monitoring data, points in time, or after a specific number of 
participants

Individual responsible for data monitoring
☒ Yes
  

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Additional considerations for FDA regulated trials 
Depending on the procedures affecting risks to participants, the site monitoring plan should 
specify:

Categorization of activities done centrally and those on-site if applicable

Monitoring methods (may include centralized/remote, on-site, and self-monitoring)

Reference to any tools used (i.e. checklists)

Identification of events that may trigger changes

Identification of deviations or failures that would be critical to study integrity
Provisions to Protect the Privacy Interests of Participants*: 

Describe the steps that will be taken to protect participants’ privacy interests. “Privacy 
interest” refers to a person’s desire to place limits on whom they interact with or whom 
they provide personal information.

Describe what steps you will take to make the participants feel at ease with the 
research situation in terms of the questions being asked and the procedures being 
performed. “At ease” does not refer to physical discomfort, but the sense of 
intrusiveness a participant might experience in response to questions, examinations, 
and procedures.

Indicate how the research team is permitted to access any sources of information about 
the participants.
☒ Yes
Economic Burden to Participants*: Describe any costs that participants may be responsible 
for because of participation in the research.
☒ Yes
Consent Process*: Describe where the consent process will take place, any waiting period 
available between informing the prospective subject and obtaining the consent; and the 
process to ensure ongoing consent.
Describe the role of the individuals listed in the application as being involved in the consent 
process; the time that will be devoted to the consent discussion; steps that will be taken to 
minimize the possibility of coercion or undue influence; and steps that will be taken to 
ensure the participants’ understanding.
Note: If you are planning to obtain consent via electronic signature, please review this 
document. Additional guidance on consent documentation and process can be found on our 
website, under the consent toolkit.
☒ Yes
Consent Process-Non-English-Speaking Participants*: 
Indicate what language(s) other than English are understood by prospective participants or 
representatives.
☒ Yes

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If participants who do not speak English will be enrolled, describe the process to ensure that 
the oral and written information provided to those participants will be in that language. 
Indicate the language that will be used by those obtaining consent.
If you checked N/A, please provide reasoning of why subjects with limited English 
proficiency are excluded. 
Note: if you stated that subjects with LEP will be enrolled, you are approved for the use of 
the Emory IRB short forms.  Please read the guidance about the use of short forms here.
Consent Process-Children: After determining if the subject is a child per GA law (or if 
enrolled outside GA, per state/country law), please describe whether parental permission 
will be obtained from:

Both parents unless one parent is deceased, unknown, incompetent, or not reasonably 
available, or when only one parent has legal responsibility for the care and custody of 
the child.

One parent even if the other parent is alive, known, competent, reasonably available, 
and shares legal responsibility for the care and custody of the child.
Describe whether permission will be obtained from individuals other than parents, and if so, 
who will be allowed to provide permission.  Describe the process used to determine these 
individuals’ authority to consent to each child’s general medical care.
When assent of children is obtained describe whether and how it will be documented per 
Emory Policies and Procedures
☒ Yes
Consent Process-Cognitively Impaired Adults:  describe the process to determine whether 
an individual is capable of consent. The IRB allows the person obtaining assent to document 
assent on the consent document and does not routinely require assent documents and does 
not routinely require children to sign assent documents.
☐ Yes
  n/a
Consent Process-Adults Unable to Consent:  List the individuals from whom permission will 
be obtained in the order of priority. (E.g., durable power of attorney for health care, a court-
appointed guardian for health care decisions, spouse, and adult child.)
For research conducted in the state, review “46 LEGALLY AUTHORIZED REPRESENTATIVES 
AND SURROGATE CONSENT” to be aware of which individuals in the state meet the 
definition of “legally authorized representative.”
For research conducted outside of the state, provide information that describes which 
individuals are authorized under applicable law to consent on behalf of a prospective 
subject to their participation in the procedure(s) involved in this research. 
Describe the process for the assent of the participants. Indicate whether:
☐ Yes
  n/a

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
Assent will be required of all, some, or none of the participants. If some, indicated, 
which participants will be required to assent and which will not.

If assent will not be obtained from some or all participants, an explanation of why not.
Describe whether the assent of the participants will be documented and the process to 
document assent. The IRB allows the person obtaining assent to document assent on the 
consent document and does not routinely require assent documents and does not routinely 
require participants to sign assent documents
Waiver or Alteration of Consent Process (consent will not be obtained, required 
information will not be disclosed, or the research involves deception) 
Review the Emory IRB waiver document to ensure you have provided sufficient information 
for the IRB to make these determinations.
If the research involves a waiver of the consent process for planned emergency research, 
please review the “CHECKLIST: Waiver of Consent for Emergency Research (HRP-419)” to 
ensure you have provided sufficient information for the IRB to make these determinations.
☐ Yes
  n/a
Setting*: Describe the sites or locations where your research team will conduct the research 
including where the subject will be identified and recruited, where the research procedures 
will be performed, and if you will involve a community advisory board.  For research 
conducted outside the organization and its affiliates describe the site-specific regulations or 
customs affecting the research outside the organization and the local scientific and ethical 
review structure outside the organization.
☒ Yes
Resources Available*: Describe the resources available to conduct the research such us the 
feasibility of recruiting the required number of suitable participants within the agreed 
recruitment period; describe the time that you will devote to conducting and completing 
the research; describe the availability of medical or psychological resources that participants 
might need as a result of an anticipated consequences of the human research; describe your 
process to ensure that all persons assisting with the research are adequately informed 
about the protocol, the research procedures, and their duties and functions.
☒ Yes
Multi-Site Research when Emory is the Lead Site:
Study -Wide Number of Participants: indicate the total number of participants to be accrued 
across all sites.
Study-Wide Recruitment Methods: If this is a multicenter study and participants will be 
recruited by methods not under the control of the local site (e.g., call centers, national 
advertisements) describe those methods.  
Describe when, where, and how potential participants will be recruited.
Describe the methods that will be used to identify potential participants.
Describe materials that will be used to recruit participants. 
☐ Yes
  n/a

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Describe the processes to ensure communication among sites. See “WORKSHEET: 
Communication and Responsibilities (HRP-830).” All sites have the most current version of 
the protocol, consent document, and HIPAA authorization.
All required approvals (initial, continuing review and modifications) have been obtained at 
each site (including approval by the site’s IRB of record).
All modifications have been communicated to sites and approved (including approval by the 
site’s IRB of record) before the modification is implemented.
All engaged participating sites will safeguard data, including secure transmission of data, as 
required by local information security policies.
All local site investigators conduct the study in accordance with applicable federal 
regulations and local laws. 
All non-compliance with the study protocol or applicable requirements will reported in 
accordance with local policy
Describe the method for communicating to engaged participating sites (see “WORKSHEET: 
Communication and Responsibilities (HRP-830)”):

Problems (inclusive of reportable events).

Interim results.

The closure of a study
If this is a multicenter study where you are a participating site/investigator, describe the 
local procedures for maintenance of confidentiality. (See “WORKSHEET: Communication and 
Responsibilities (HRP-830).”)

Where and how data or specimens will be stored locally?

How long the data or specimens will be stored locally?

Who will have access to the data or specimens locally?

Who is responsible for receipt or transmission of the data or specimens locally?

How data and specimens will be transported locally?