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Sugammadex vs Neostigmine Reversal in Pediatric Appendectomy

Effectiveness of Sugammadex Versus Neostigmine on Neuromuscular Reversal in Pediatric Patients Undergoing Laparoscopic Appendectomy for Acute Appendicitis: A Randomized Controlled Trial

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05256901
Enrollment
22
Registered
2022-02-25
Start date
2023-07-19
Completion date
2024-08-05
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis, Surgery

Keywords

laparoscopic

Brief summary

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.

Detailed description

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 predominantly 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 prompted 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 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 of 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 the 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. The research team hypothesizes that the utilization of sugammadex in pediatrics results in a quicker return to bowel function. This has previously been demonstrated in adults, but data are lacking in the pediatric population. Researchers 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 underdose rocuronium in these short procedures, due to a 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, researchers 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.

Interventions

DRUGSugammadex

Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or more.

Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present.

Sponsors

Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Patients 2-17 years of age * Diagnosis of acute appendicitis * Patient undergoing laparoscopic appendectomy at Children's Healthcare of Atlanta- Egleston. * Parent or Legal Authorized Representative willing to participate, able to understand and sign an informed consent

Exclusion criteria

* Patient with an allergy to Sugammadex or Neostigmine * History of renal dysfunction * Parent or legal guardian unwilling or unable or unable to understand the informed consent

Design outcomes

Primary

MeasureTime frameDescription
Total Time From Surgery End to Out of the Operating Room (OR)Up to 2 hoursThe time from the end of surgery to discharge from the OR will be evaluated via the Epic computer chart after discharge from the hospital.

Secondary

MeasureTime frameDescription
Total Time to First Bowel MovementUp to 48 hoursTime to first bowel movement will be evaluated via the Epic computer record after discharge from the hospital
Total Time to Tolerance of an Oral DietUp to 24 hoursThe research team will evaluate via the Epic computer record after discharge from the hospital
Total Time of Inhalational Anesthesia ExposureUp to 5 hours (depending on length of surgical procedure)evaluated via the Epic computer record after discharge from the hospital
Length of Stay in the Post-anesthesia Care Unit (PACU)Up to 5 hours (on average depending on post anesthesia recovery)PACU length of stay was evaluated via the Epic computer record after discharge from the hospital
Hospital Length of Stay (LoS)Up to 5 days (depending on length of hospitalization)Hospital LoS will be evaluated via the Epic computer record after discharge from the hospital

Countries

United States

Participant flow

Participants by arm

ArmCount
Sugammadex
The reversal agent, Sugammadex, will be administered at the start of closure. Sugammadex: Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or greater.
11
Neostigmine/Glycopyrrolate
The reversal agent, Neostigmine, will be administered at the start of closure. Neostigmine/Glycopyrrolate: Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present.
11
Total22

Baseline characteristics

CharacteristicTotalSugammadexNeostigmine/Glycopyrrolate
Age, Categorical
<=18 years
22 Participants11 Participants11 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous11.37 years
STANDARD_DEVIATION 3.63
12.55 years
STANDARD_DEVIATION 3.5
10.18 years
STANDARD_DEVIATION 3.52
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
9 Participants5 Participants4 Participants
Race (NIH/OMB)
More than one race
3 Participants1 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
10 Participants5 Participants5 Participants
Region of Enrollment
United States
22 participants11 participants11 participants
Sex: Female, Male
Female
10 Participants4 Participants6 Participants
Sex: Female, Male
Male
12 Participants7 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 110 / 11
other
Total, other adverse events
0 / 110 / 11
serious
Total, serious adverse events
0 / 110 / 11

Outcome results

Primary

Total Time From Surgery End to Out of the Operating Room (OR)

The time from the end of surgery to discharge from the OR will be evaluated via the Epic computer chart after discharge from the hospital.

Time frame: Up to 2 hours

ArmMeasureValue (MEAN)Dispersion
SugammadexTotal Time From Surgery End to Out of the Operating Room (OR)9.55 minutesStandard Deviation 3.03
Neostigmine/GlycopyrrolateTotal Time From Surgery End to Out of the Operating Room (OR)10.82 minutesStandard Deviation 4.87
Secondary

Hospital Length of Stay (LoS)

Hospital LoS will be evaluated via the Epic computer record after discharge from the hospital

Time frame: Up to 5 days (depending on length of hospitalization)

ArmMeasureValue (MEAN)Dispersion
SugammadexHospital Length of Stay (LoS)34.64 hoursStandard Deviation 39.07
Neostigmine/GlycopyrrolateHospital Length of Stay (LoS)49.51 hoursStandard Deviation 50.56
Secondary

Length of Stay in the Post-anesthesia Care Unit (PACU)

PACU length of stay was evaluated via the Epic computer record after discharge from the hospital

Time frame: Up to 5 hours (on average depending on post anesthesia recovery)

ArmMeasureValue (MEAN)Dispersion
SugammadexLength of Stay in the Post-anesthesia Care Unit (PACU)27.91 minutesStandard Deviation 9.07
Neostigmine/GlycopyrrolateLength of Stay in the Post-anesthesia Care Unit (PACU)37.73 minutesStandard Deviation 12.65
Secondary

Total Time of Inhalational Anesthesia Exposure

evaluated via the Epic computer record after discharge from the hospital

Time frame: Up to 5 hours (depending on length of surgical procedure)

ArmMeasureValue (MEAN)Dispersion
SugammadexTotal Time of Inhalational Anesthesia Exposure121.30 minutesStandard Deviation 40.14
Neostigmine/GlycopyrrolateTotal Time of Inhalational Anesthesia Exposure142.94 minutesStandard Deviation 34.32
Secondary

Total Time to First Bowel Movement

Time to first bowel movement will be evaluated via the Epic computer record after discharge from the hospital

Time frame: Up to 48 hours

ArmMeasureValue (MEAN)Dispersion
SugammadexTotal Time to First Bowel Movement18.4 hoursStandard Deviation 6.7
Neostigmine/GlycopyrrolateTotal Time to First Bowel Movement23.78 hoursStandard Deviation 16.74
Secondary

Total Time to Tolerance of an Oral Diet

The research team will evaluate via the Epic computer record after discharge from the hospital

Time frame: Up to 24 hours

ArmMeasureValue (MEAN)Dispersion
SugammadexTotal Time to Tolerance of an Oral Diet4.3 hoursStandard Deviation 1.96
Neostigmine/GlycopyrrolateTotal Time to Tolerance of an Oral Diet8.05 hoursStandard Deviation 6.75

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026