Sugammadex vs Neostigmine Reversal for Pediatric Appendectomy
Recruiting in Palo Alto (17 mi)
Overseen byLaura Gilbertson, MD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Emory University
Disqualifiers: Allergy to Sugammadex, Neostigmine, Renal dysfunction
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is sugammadex safe for reversing neuromuscular blockade in pediatric patients?
How does the drug sugammadex differ from neostigmine for reversing neuromuscular blockade in pediatric appendectomy?
Sugammadex is unique because it works by directly encapsulating and removing the neuromuscular blocking agents rocuronium and vecuronium, leading to a faster and more complete reversal of muscle paralysis compared to neostigmine. Unlike neostigmine, sugammadex does not have cardiovascular, respiratory, or cholinergic side effects, making it a safer option for reversing neuromuscular blockade, especially in pediatric patients.25678
Eligibility Criteria
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.Inclusion Criteria
I am between 2 and 17 years old.
I am having my appendix removed at Children's Healthcare of Atlanta-Egleston.
I have been diagnosed with acute appendicitis.
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Exclusion Criteria
Patient with an allergy to Sugammadex or Neostigmine
I have had kidney problems in the past.
Parent or legal guardian unwilling or unable to understand the informed consent
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants undergo laparoscopic appendectomy with neuromuscular reversal using either sugammadex or neostigmine/glycopyrrolate
1 day
1 visit (in-person)
Post-operative Monitoring
Participants are monitored for return of bowel function, tolerance of oral diet, and recovery from anesthesia
Up to 72 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 14 days
Treatment Details
Interventions
- Neostigmine/Glycopyrrolate (Cholinesterase Inhibitor)
- Sugammadex (Selective Relaxant Binding Agent)
Trial OverviewThe 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.
Participant Groups
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Healthcare of AltantaAtlanta, GA
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Who Is Running the Clinical Trial?
Emory UniversityLead Sponsor
References
Sugammadex versus neostigmine for routine reversal of rocuronium block in adult patients: A cost analysis. [2021]This report analyzes the comparative costs, efficacy and side effects of a newer, more expensive reversal drug, sugammadex, with its generic counterpart, neostigmine combined with glycopyrrolate, or no reversal agent when used routinely to reverse rocuronium-induced neuromuscular blockade in adult patients.
The efficacy and safety of sugammadex for reversing postoperative residual neuromuscular blockade in pediatric patients: A systematic review. [2023]The aim of this study is to evaluate the efficacy and safety of sugammadex for reversing neuromuscular blockade in pediatric patients. MEDLINE and other three Databases were searched. Randomized clinical trials were included if they compared sugammadex with neostigmine or placebo in pediatric patients undergoing surgery involving the use of rocuronium or vecuronium. The primary outcome was the time interval from administration of reversal agents to train-of-four ratio (TOFr, T4/T1) > 0.9. Incidences of any drug-related adverse events were secondary outcomes. Trial inclusion, data extraction, and risk of bias assessment were performed independently. Mean difference and relative risk were used as summary statistics with random effects models. Statistical heterogeneity was assessed by the I2 statistic. Funnel plot was used to detect publication bias. Ten studies with 580 participants were included. Although considerable heterogeneity (I2 = 98.5%) was detected in primary outcome, the results suggested that, compared with placebo or neostigmine, sugammadex can reverse rocuronium-induced neuromuscular blockade more rapidly with lower incidence of bradycardia. No significant differences were found in the incidences of other adverse events. Compared with neostigmine or placebo, sugammadex may reverse rocuronium-induced neuromuscular blockade in pediatric patients rapidly and safely.
Effects of Reversal Technique for Neuromuscular Paralysis on Time to Recovery of Bowel Function after Craniotomy. [2023]Non-depolarizing neuromuscular blockade can be reversed with neostigmine/glycopyrrolate or sugammadex. We test the hypothesis that sugammadex is associated with earlier postoperative recovery of bowel function (first bowel movement, BM).
A discrete event simulation model of clinical and operating room efficiency outcomes of sugammadex versus neostigmine for neuromuscular block reversal in Canada. [2018]The objective of this analysis is to explore potential impact on operating room (OR) efficiency and incidence of residual neuromuscular blockade (RNMB) with use of sugammadex (Bridion™, Merck & Co., Inc., Kenilworth, NJ USA) versus neostigmine for neuromuscular block reversal in Canada.
Clinical Impact of Sugammadex in the Reversal of Neuromuscular Blockade. [2021]Background A neuromuscular blockade (NMB) is used in general anesthesia to facilitate endotracheal intubation and muscle relaxation during procedural and surgical interventions. Rapid and complete reversal of the NMB allows for patient recovery to the preoperative baseline with ventilation and motor function, along with the complete return of gastroesophageal motility, thereby expediting recovery and preventing microaspiration in the postoperative period. Sugammadex is a modified gamma cyclodextrin that complexes with steroidal neuromuscular blocking agents (specifically, rocuronium and vecuronium), leading to a molecular gradient and removal of the agents from the neuromuscular junction. Sugammadex has been shown to have a more rapid reversal of neuromuscular blockade compared to neostigmine. The purpose of this study was to evaluate if perioperative efficiency was increased when sugammadex was used for paralytic reversal compared to the traditional regimen of neostigmine and glycopyrrolate. Methods A retrospective cohort study of patients admitted for surgical intervention in June 2019 was conducted. Two groups were compared: those who received sugammadex for reversal and those who received neostigmine, plus glycopyrrolate. The primary outcome was time to extubation from the administration of the reversal agent. Results Two hundred seventy-one surgical cases were evaluated. Average doses of sugammadex for those with profound neuromuscular blockade as indicated by a train of four (TOF) of 0 - 2 was 2.47 (0.9) mg/kg for sugammadex and 0.042 (0.01) mg/kg for neostigmine, plus glycopyrrolate. Seventeen patients in the sugammadex group experienced bradycardia after reversal compared to 22 in the neostigmine, plus glycopyrrolate, group (p = 0.73). Reintubation was required for three patients in the neostigmine, plus glycopyrrolate, group and no patients in the sugammadex group. The mean time to extubation from the procedure end comparing reversal with sugammadex and neostigmine, plus glycopyrrolate, was 12.5 (7.6) minutes versus 13.7 (8.8) minutes (p = 0.44), respectively. Comparison of reversal with sugammadex versus neostigmine, plus glycopyrrolate, and time spent in the post-anesthesia care unit was 83.6 (48.6) minutes versus 81.7 (46.6) (p = 0.73), respectively. Conclusions In this retrospective cohort study, we observed a deviation in the recommended sugammadex dosage and increased reintubation rates but no difference in time to extubation or Post-Anesthesia Care Unit (PACU) length of stay times when patients received sugammadex compared to neostigmine, plus glycopyrrolate, for neuromuscular blockade reversal. Understanding the PACU flow and culture, education of providers about dosages, along with completion of prospective studies, to correlate acceleromyograph values to reversal and postoperative ventilatory and deglutary function can help assess the true clinical value of sugammadex.
Bradycardic Arrest in a Child with Complex Congenital Heart Disease Due to Sugammadex Administration. [2023]The neuromuscular blocking drugs rocuronium and vecuronium are often used during general anesthesia. These drugs temporarily paralyze the patient and thus both facilitate placement of an endotracheal tube and prevent any patient movement during surgery. Reversal of neuromuscular blockade is necessary at the end of surgery to avoid postoperative weakness and adverse respiratory events in the recovery room. Neostigmine, the traditional reversal agent, may not completely restore muscle strength. Sugammadex is a reversal agent that is more effective and quicker acting than neostigmine. In adults, sugammadex administration has rarely been associated with bradycardia and cardiac arrest. In healthy children, the bradycardia that occurs after sugammadex administration is benign and does not require intervention. There is 1 case report of a 10- to 15-second bradycardic arrest after sugammadex administration to a 10-year-old child with heart disease. The present case report describes an 8-month-old child with complex congenital heart disease who experienced a 10-minute bradycardic arrest after the administration of sugammadex. Pediatric anesthesiologists should be aware that sugammadex administration to children with heart disease may cause hemodynamically significant bradycardia.
Emergency use of sugammadex after failure of standard reversal drugs and postoperative pulmonary complications: A retrospective cohort study. [2023]The use of sugammadex instead of neostigmine for the reversal of neuromuscular blockade may decrease postoperative pulmonary complications. It is unclear if this finding is applicable to situations where sugammadex is administered after the administration of neostigmine. The objective of this study was to compare the incidence of a composite outcome measure of major postoperative pulmonary complications in patients who received sugammadex as a rescue agent after neostigmine versus those who received sugammadex alone for reversal of neuromuscular blockade.
A novel approach to reversal of neuromuscular blockade. [2018]Postoperative residual curarization is still a problem of the modern anesthesia. Neostigmine is not the safest drug that allows a safe decurarization, especially when neuromuscular transmission monitoring is not used. Sugammadex is a A-cyclodextrin designed to encapsulate rocuronium bromide, providing a rapid reversal of neuromuscular blockade. It has not cardiovascular, respiratory and cholinergic effects. It has been used in renally impaired patients with no neuromuscular blockade recurrence. Sugammadex reverses either a shallow or a deep neuromuscular block. Volatile agents such as sevoflurane seems not to influence the sugammadex ability to reverse the rocuronium neuromuscular blockade. There is no difference in the sugammadex pharmacokinetic in children and adults. Sugammadex would be able to have a role in the future in reversing a non depolarizing steroidal neuromuscular block.