Sugammadex vs Neostigmine Reversal in Pediatric Appendectomy

Phase 4

Terminated

Conditions: Appendicitis
Surgery

Interventions: Drug: Sugammadex
Drug: Neostigmine/Glycopyrrolate

Registration Number: NCT05256901

Lead Sponsor: Emory University

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.

Detailed Description: Patients presenting to the operating room for laparoscopic appendectomy with a diagnosis of acute appendicitis require rapid sequence induction (RSI) due to significant vomiting and concern for increased gastric content. For this reason, succinylcholine-accompanied by neostigmine-is predominantly used in adults for RSI to prevent potential aspiration. Unfortunately, in pediatric patients, there are many concerns about the use of succinylcholine, including complications such as bradycardia, hyperkalemia, dysrhythmias, and cardiac arrest from undiagnosed skeletal muscle myopathy. For many anesthesiologists, these concerns prompted the decision to use a non-depolarizing muscle relaxant such as rocuronium for induction. However, if the standard RSI dose is used, it often results in residual paralysis at the end of short procedures such as laparoscopic appendectomies. It has recently been demonstrated that prolonged paralysis is prevalent even at low doses of rocuronium in pediatric patients. For these reasons, it is imperative to find a way to provide adequate and safe

RSI conditions for intubation, appropriate muscle relaxation for laparoscopic procedures, and the ability to quickly reverse neuromuscular blockade in this pediatric population. Sugammadex has the potential to allow for the utilization of an appropriate RSI dose of rocuronium for intubation, as it provides the ability to reverse neuromuscular blockade earlier than the neostigmine reversal, which is currently the standard of care. Retrospective reviews have shown the use of Sugammadex in pediatric patients to be safe and effective. However, there has not been prospective data about the effect on operating room efficiency of brief pediatric procedures such as laparoscopic appendectomies, one of the most common urgent pediatric surgeries performed. There are numerous other potential benefits of using sugammadex over typical reversal, including the quicker return of bowel function, faster time to tolerance of an oral diet, and decreased exposure to volatile anesthesia. The return of bowel function is particularly important in pediatric patients undergoing laparoscopic procedures. The research team hypothesizes that the utilization of sugammadex in pediatrics results in a quicker return to bowel function. This has previously been demonstrated in adults, but data are lacking in the pediatric population. Researchers also hypothesize that patients receiving sugammadex versus neostigmine reversal will have an improved time to tolerance of an oral diet, which may impact wound healing and nutrition. As anesthesiologists often underdose rocuronium in these short procedures, due to a lack of quick reversal options, high levels of volatile anesthesia are utilized to compensate for inadequate muscle relaxation. With the use of sugammadex allowing for proper muscle relaxation throughout the entire case, researchers hypothesize that patients will have a lower total volatile anesthetic exposure during the procedure. This is exceedingly important in pediatric anesthesia, where the detrimental effects of volatile anesthetics on the developing brain have been demonstrated in numerous animal studies.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 22

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugammadex	Sugammadex	The reversal agent, Sugammadex, will be administered at the start of closure.
Neostigmine/Glycopyrrolate	Neostigmine/Glycopyrrolate	The reversal agent, Neostigmine, will be administered at the start of closure.

Primary Outcome Measures

Name	Time	Method
Total Time From Surgery End to Out of the Operating Room (OR)	Up to 2 hours	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.

Secondary Outcome Measures

Name	Time	Method
Total Time to First Bowel Movement	Up to 48 hours	Time to first bowel movement will be evaluated via the Epic computer record after discharge from the hospital
Total Time of Inhalational Anesthesia Exposure	Up to 5 hours (depending on length of surgical procedure)	evaluated via the Epic computer record after discharge from the hospital
Total Time to Tolerance of an Oral Diet	Up to 24 hours	The research team will evaluate via the Epic computer record after discharge from the hospital
Length of Stay in the Post-anesthesia Care Unit (PACU)	Up to 5 hours (on average depending on post anesthesia recovery)	PACU length of stay was evaluated via the Epic computer record after discharge from the hospital
Hospital Length of Stay (LoS)	Up to 5 days (depending on length of hospitalization)	Hospital LoS will be evaluated via the Epic computer record after discharge from the hospital

Trial Locations

Locations (1): Children's Healthcare of Atlanta
🇺🇸
Atlanta, Georgia, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States