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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
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 hours
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 moreTrial 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
1,688 Previous Clinical Trials
2,602,795 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 2 and 17 years old.I am having my appendix removed at Children's Healthcare of Atlanta-Egleston.I have had kidney problems in the past.I have been diagnosed with acute appendicitis.
Research Study Groups:
This trial has the following groups:- Group 1: Sugammadex
- Group 2: Neostigmine/Glycopyrrolate
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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