Sugammadex vs Neostigmine Reversal in Pediatric Appendectomy

Surgery Clinical Trial

Official title:

Effectiveness of Sugammadex Versus Neostigmine on Neuromuscular Reversal in Pediatric Patients Undergoing Laparoscopic Appendectomy for Acute Appendicitis: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05256901
• Other study ID #: STUDY00003913
• Status: Recruiting
• Phase: Phase 4
• Start date: July 19, 2023
• Est. completion date: March 19, 2025

Study information

• Verified date: September 2023
• Source: Emory University
• Contact: Laura Gilbertson, MD
• Phone: 404-785-6670
• Email: lgilbe5[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 predominately 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 on 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 hypothesis is that the utilization of sugammadex in pediatrics results in a quicker return to bowel function. This has previously been demonstrated in adults, but data is 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 under-dose 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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 19, 2025
• Est. primary completion date: October 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Surgery

Intervention

Drug:
• Sugammadex
Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or greater.
• Neostigmine/Glycopyrrolate
Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present.

Locations

Country	Name	City	State
United States	Children's Healthcare of Altanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total hours from surgery end to out of the operating room (OR)	Hours from surgery end to out of the OR will be evaluated via the Epic computer chart after discharge from the hospital.	Up to 2 hours
Secondary	Total hours to first bowel movement	Hours to first bowel movement will be evaluated via the Epic computer record after discharge from the hospital	Up to 72 hours
Secondary	Total hours to tolerance of an oral diet	The research team will evaluate via the Epic computer record after discharge from the hospital	Up to 72 hours
Secondary	Total hours of inhalational anesthesia exposure	will be evaluated via the Epic computer record after discharge from the hospital	Up to 5 hours (depending on length of surgical procedure)
Secondary	Length of stay (hours) in the Post-anesthesia care unit (PACU)	PACU length of stay will be evaluated via the Epic computer record after discharge from the hospital	Up to 5 hours (depending on post anesthesia recovery)
Secondary	Hospital length of stay (LoS)	Hospital LoS will be evaluated via the Epic computer record after discharge from the hospital	Up to 14 days (depending on length of hospitalization)