Comparing Sugammadex and Neostigmine for Pediatric Appendectomy Recovery
Effectiveness of Sugammadex Versus Neostigmine on Neuromuscular Reversal in Pediatric Patients Undergoing Laparoscopic Appendectomy for Acute Appendicitis: A Randomized Controlled Trial
This study is testing whether a new drug called sugammadex works better than the standard treatment for helping kids recover from anesthesia after having their appendix removed.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05256901 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled trial that compares the effectiveness of sugammadex versus neostigmine/glycopyrrolate for reversing neuromuscular blockade in pediatric patients undergoing laparoscopic appendectomy. The study focuses on children aged 2-17 years diagnosed with acute appendicitis, aiming to ensure safe and effective anesthesia management. By allowing anesthesiologists to make informed decisions on timing and dosage without blinding, the trial seeks to address the challenges of residual paralysis associated with traditional reversal methods. The single-center study is conducted at Children's Healthcare of Atlanta.
Who should consider this trial
Good fit: Ideal candidates are children aged 2-17 years diagnosed with acute appendicitis who are scheduled for laparoscopic appendectomy.
Not a fit: Patients with allergies to sugammadex or neostigmine, or those with a history of renal dysfunction, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective anesthesia practices for pediatric patients undergoing laparoscopic appendectomies.
How similar studies have performed: Other studies have shown promising results with sugammadex in similar contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia
- Children's Healthcare of Altanta — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Laura Gilbertson, MD — Emory University
- Study coordinator: Laura Gilbertson, MD
- Email: lgilbe5@emory.edu
- Phone: 404-785-6670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.