Sugammadex vs Neostigmine Reversal in Pediatric Appendectomy

NCT05256901 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: STUDY00003913
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis; Surgery

Keywords

laparoscopic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total Time to First Bowel Movement

  Up to 48 hours

• Total Time to Tolerance of an Oral Diet

  Up to 24 hours

• Total Time of Inhalational Anesthesia Exposure

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

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

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

• Hospital Length of Stay (LoS)

  Up to 5 days (depending on length of hospitalization)

Study Arms (2)

Sugammadex

EXPERIMENTAL

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

Drug: Sugammadex

Neostigmine/Glycopyrrolate

ACTIVE COMPARATOR

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

Drug: Neostigmine/Glycopyrrolate

Interventions

Sugammadex DRUG

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

Also known as: Intervention Group

Sugammadex

Neostigmine/Glycopyrrolate 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.

Also known as: Regular Care

Neostigmine/Glycopyrrolate

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Sugammadex; Neostigmine; Glycopyrrolate

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Viola Vaccarino, MD, PhD, Principal Investigator
• Organization: Emory University

lvaccar@emory.edu

404-727-8710

Study Officials

• Laura Gilbertson, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 25, 2022
• Study Start: July 19, 2023
• Primary Completion: July 5, 2024
• Study Completion: August 5, 2024
• Last Updated: September 30, 2025
• Results First Posted: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The research team will share the data immediately following publication and ending 3 years following article publication.
• Access Criteria: Proposals should be directed to laura.gilbertson@emory.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)