Sugammadex vs Neostigmine Reversal in Pediatric Appendectomy

NCT ID: NCT05256901

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-19
• Study Completion Date: 2024-08-05

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.

Conditions

Appendicitis; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Sugammadex

The reversal agent, Sugammadex, will be administered at the start of closure.

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

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

Neostigmine/Glycopyrrolate

The reversal agent, Neostigmine, will be administered at the start of closure.

Group Type: ACTIVE_COMPARATOR

Neostigmine/Glycopyrrolate

Intervention Type: DRUG

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

Interventions

Sugammadex

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Intervention Group; Regular Care

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Laura Gilbertson

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Gilbertson, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00003913

Identifier Type: -

Identifier Source: org_study_id