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

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.

Study Overview

• Status: Terminated
• Conditions: Surgery; Appendicitis
• Intervention / Treatment: Drug: Neostigmine/Glycopyrrolate; Drug: Sugammadex

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Children's Healthcare of Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sugammadex; The reversal agent, Sugammadex, will be administered at the start of closure.	Drug: Sugammadex; Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or more.; Other Names: Intervention Group
Active Comparator: Neostigmine/Glycopyrrolate; The reversal agent, Neostigmine, will be administered at the start of closure.	Drug: 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.; Other Names: Regular Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Time to First Bowel Movement	Time to first bowel movement will be evaluated via the Epic computer record after discharge from the hospital	Up to 48 hours
Total Time to Tolerance of an Oral Diet	The research team will evaluate via the Epic computer record after discharge from the hospital	Up to 24 hours
Total Time of Inhalational Anesthesia Exposure	evaluated via the Epic computer record after discharge from the hospital	Up to 5 hours (depending on length of surgical procedure)
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	Up to 5 hours (on average depending on post anesthesia recovery)
Hospital Length of Stay (LoS)	Hospital LoS will be evaluated via the Epic computer record after discharge from the hospital	Up to 5 days (depending on length of hospitalization)

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Laura Gilbertson, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2023
• Primary Completion (Actual): July 5, 2024
• Study Completion (Actual): August 5, 2024

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: laparoscopic
• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Cecal Diseases; Intraabdominal Infections; Appendicitis; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates; Polycyclic Compounds; Amines; Polysaccharides; Macrocyclic Compounds; Phenylammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds; Pyrrolidines; gamma-Cyclodextrins; Cyclodextrins; Dextrins; Starch; Glucans; Glycopyrrolate; Neostigmine; Sugammadex
• Other Study ID Numbers: STUDY00003913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The research team will share Individual participant data that underlie the results (text, tables, figures, and appendices) reported in the article, after the deidentification
• IPD Sharing Time Frame: The research team will share the data immediately following publication and ending 3 years following article publication.
• IPD Sharing Access Criteria: Proposals should be directed to laura.gilbertson@emory.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No