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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 hours

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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I am having my appendix removed at Children's Healthcare of Atlanta-Egleston.

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I have been diagnosed with acute appendicitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 72 hours

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Total hours from surgery end to out of the operating room (OR)

Secondary outcome measures

Hospital length of stay (LoS)

Length of stay (hours) in the Post-anesthesia care unit (PACU)

Total hours of inhalational anesthesia exposure

+2 more

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,639 Previous Clinical Trials

2,560,526 Total Patients Enrolled

3 Trials studying Surgery

121 Patients Enrolled for Surgery

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

Surgery Research Study Groups: Sugammadex, Neostigmine/Glycopyrrolate

Surgery Clinical Trial 2023: Sugammadex Highlights & Side Effects. Trial Name: NCT05256901 — Phase 4

Sugammadex 2023 Treatment Timeline for Medical Study. Trial Name: NCT05256901 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential hazards can be associated with Sugammadex?

"We do not anticipate any major safety issues with Sugammadex, as evidenced by its score of 3. This is a Phase 4 trial that has already gained regulatory approval."

Answered by AI

Are participants aged 20 and over eligible to enroll in this trial?

"This medical experiment is seeking minors aged between 2 and 17 years old."

Answered by AI

What qualifications are necessary to qualify for enrollment in this trial?

"Qualified participants for this clinical trial must be afflicted with appendicitis and between the ages of two to seventeen. A maximum of 120 individuals are being accepted into the study."

Answered by AI

Are there any volunteers being sought for this research endeavor?

"This particular medical trial, which was posted on the first of January 2023 and last updated November 7th 2022, is not actively seeking enrollees at this moment. However, 281 other studies are currently in need of volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sugammadex vs Neostigmine Reversal in Pediatric Appendectomy

Laura Gilbertson 2023. "Sugammadex vs Neostigmine Reversal in Pediatric Appendectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05256901.

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