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Sugammadex vs Neostigmine Reversal for Pediatric Appendectomy

Phase 4
Recruiting
Led By Laura Gilbertson, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients 2-17 years of age
Patient undergoing laparoscopic appendectomy at Children's Healthcare of Atlanta- Egleston
Must not have
History of renal dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 hours
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing two ways to reverse neuromuscular blockade. One group will get sugammadex and the other neostigmine/glycopyrrolate. The trial is notblinded, so the anesthesiologist will know which reversal method is being used.

Who is the study for?
This trial is for children aged 2-17 undergoing laparoscopic appendectomy at Children's Healthcare of Atlanta-Egleston, diagnosed with acute appendicitis. Participants need a parent or guardian to understand and sign consent. It excludes those with kidney issues or allergies to Sugammadex or Neostigmine.
What is being tested?
The study compares two drugs used after surgery to reverse muscle relaxation: Sugammadex and Neostigmine/Glycopyrrolate. Kids are randomly chosen to receive one of these drugs during an appendectomy in this non-blinded, single-center trial.
What are the potential side effects?
Possible side effects from Sugammadex include allergic reactions, changes in heart rate, and mild symptoms like nausea or headache. Neostigmine/Glycopyrrolate may cause slower heart rate, saliva production changes, vision problems, and gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 2 and 17 years old.
Select...
I am having my appendix removed at Children's Healthcare of Atlanta-Egleston.
Select...
I have been diagnosed with acute appendicitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had kidney problems in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total hours from surgery end to out of the operating room (OR)
Secondary study objectives
Hospital length of stay (LoS)
Length of stay (hours) in the Post-anesthesia care unit (PACU)
Total hours of inhalational anesthesia exposure
+2 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SugammadexExperimental Treatment1 Intervention
The reversal agent, Sugammadex, will be administered at the start of closure.
Group II: Neostigmine/GlycopyrrolateActive Control1 Intervention
The reversal agent, Neostigmine, will be administered at the start of closure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sugammadex
2017
Completed Phase 4
~3410

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,708 Previous Clinical Trials
2,607,364 Total Patients Enrolled
Laura Gilbertson, MDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
63 Total Patients Enrolled

Media Library

Sugammadex Clinical Trial Eligibility Overview. Trial Name: NCT05256901 — Phase 4
Appendicitis Research Study Groups: Sugammadex, Neostigmine/Glycopyrrolate
Appendicitis Clinical Trial 2023: Sugammadex Highlights & Side Effects. Trial Name: NCT05256901 — Phase 4
Sugammadex 2023 Treatment Timeline for Medical Study. Trial Name: NCT05256901 — Phase 4
~27 spots leftby May 2025
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