Sugammadex vs Neostigmine Reversal for Pediatric Appendectomy
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
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.
What data supports the idea that Sugammadex vs Neostigmine Reversal for Pediatric Appendectomy is an effective drug?The available research does not provide any data on Sugammadex or Neostigmine Reversal for Pediatric Appendectomy. The articles focus on other medical conditions and treatments, such as thyroid issues and heart rate management, but do not mention Sugammadex or Neostigmine in the context of pediatric appendectomy. Therefore, there is no information here to support the effectiveness of these drugs for that specific use.123511
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is sugammadex a promising drug for reversing muscle relaxation in children after surgery?Yes, sugammadex is a promising drug for reversing muscle relaxation in children after surgery. It works faster and more effectively than the traditional drug, neostigmine, and has a lower chance of causing certain side effects like bradycardia, which is a slow heart rate. This means it can help children recover more quickly and safely after surgery.4791213
What safety data exists for Sugammadex and Neostigmine in pediatric appendectomy?A systematic review of 10 studies with 580 pediatric participants found that Sugammadex reverses rocuronium-induced neuromuscular blockade more rapidly than Neostigmine, with a lower incidence of bradycardia. No significant differences were found in other adverse events, suggesting that Sugammadex is a safe option for pediatric patients.678910
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.
Exclusion Criteria
I have had kidney problems in the past.
Treatment Details
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.
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
[Preoperative care and anesthesia in surgical treatment of thyrotoxicosis]. [2015]The authors made an analysis of clinical materials pertaining to 1234 patients with thyrotoxicosis, who were given different preoperative management and operated upon under local and general anesthesia. It is noted, that there is less number of postoperative thyrotoxic crises after mercosolyl administration in combination with reserpine and nonspecific drugs than after Plummer preoperative preparation (0.1% versus 1.2%).
Propylthiouracil-induced hepatic failure and encephalopathy in a child. [2019]Propylthiouracil (PTU) is the most common antithyroid medication utilized in children for the treatment of hyperthyroidism. An adverse effect of PTU reported infrequently is hepatic injury. The child described here is the fifth reported case of severe hepatic injury in the pediatric age group and documents that clinical or biochemical evidence of hepatic injury requires immediate discontinuation of PTU.
[Therapeutic drug monitoring in perioperative period--management of atrial fibrillation in a patient with bradycardia due to relative overdose of digitalis]. [2013]We reported a 79 year old man with preoperative bradycardia due to relative overdose of digitalis prior to undergoing subtotal gastrectomy. The patient had received metildigoxin 0.2 mg.day-1 for atrial fibrillation preoperatively and severe bradycardia of 35-41 bpm was found on the preoperative ECG examination. Serum digoxin level was detected to be 1.91 ng.ml-1 on the day before surgery. We thought this serum level must be toxic for him, even though it was within normal limits for the majority. As we thought that his bradycardia had been caused by relative overdose of digitalis, he was withheld to receive metildigoxin on the day before surgery and thereafter. Heart rate on arrival at the operating theater was around 40-45 bpm, and therefore the patient was placed on a temporary pacemaker catheter before the anesthetic induction to prevent aggravating bradycardia during anesthesia and surgery. Heart rate during procedure was 50-70 bpm and hemodynamics was stable. Intravenous digoxin was restarted on the 2nd postoperative day because of decrease in serum digoxin level to 0.84 ng.ml-1 and it was converted to metildigoxin 0.1 mg.day-1 when he was permitted to take pills per os. Our experience demonstrates that perioperative therapeutic drug monitoring is clinically important for anesthesiologists to make proper pharmacological management of surgical patients who have received digitalis.
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.
Rapid preoperative blockage of thyroid hormone production / secretion in patients with Graves' disease. [2018]Preoperative management of hyperthyroid patients with Graves' disease who are unable to tolerate thionamides or have poor adherence to therapy is a challenging clinical problem. The goal of our study was to demonstrate the clinical efficacy of a rapid preoperative thyroid hormone blocking protocol and to assess specific surgical and treatment-related complications.
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.
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.
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.
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.
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).
Non-thionamide antithyroid drug options in Graves' hyperthyroidism. [2023]The thionamide anti-thyroid drugs namely carbimazole, methimazole, and propylthiouracil, have been the predominant therapy modality for Graves' hyperthyroidism for over 60 years. Although these agents have proven efficacy and favorable side-effect profiles, non-thionamide alternatives are occasionally indicated in patients who are intolerant or unresponsive to thionamides alone. This review examines the available non-thionamide drug options for the control of Graves' hyperthyroidism and summarizes their clinical utility, efficacy, and limitations.
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.
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.