Efficacy and safety of sugammadex for reversal of neuromuscular blockade in pediatric patients: an updated systematic review and meta-analysis of randomized controlled trials with trial sequential analysis.

Abstract

Background: Sugammadex has recently been approved globally for use in pediatric patients aged ≥ 2 years. This meta-analysis with trial sequential analysis (TSA) evaluated the efficacy and safety of sugammadex for reversal of neuromuscular blockade (NMB) in pediatric patients.

Methods: PubMed, EMBASE, the Cochrane Library, Web of Science, Scopus, KoreaMed, and ClinicalTrials.gov were searched from inception to December 31, 2023. Randomized controlled trials (RCTs) evaluating sugammadex in pediatric patients were included. Efficacy outcomes were time to recovery to a train-of-four (TOF) ratio ≥ 0.9 and extubation time. Safety outcomes included overall post-anesthetic adverse events, bradycardia, tachycardia, postoperative nausea and vomiting (PONV), recurarization, and desaturation. Data were analyzed using RevMan, and TSA was performed using Copenhagen Trial Unit software.

Results: A total of 21 RCTs (n=1,394 pediatric patients) were included in the study. Time to TOF ratio ≥ 0.9 was significantly shorter with sugammadex than with control (neostigmine or placebo) for both 2 mg/kg (mean difference [95% confidence interval], -6.03 [-7.85 to -4.21] min) and 4 mg/kg (-30.06 [-37.58 to -22.55] min). The extubation time was shorter with sugammadex (-14.26 [-17.22 to -11.30] min). The TSA for both efficacy outcomes indicated that the required information size had been reached, suggesting that additional trials are unlikely to change the efficacy conclusions. PONV, tachycardia, and desaturation occurred less frequently with sugammadex, whereas the overall post-anesthetic adverse events, recurarization, and bradycardia were comparable.

Conclusions: Sugammadex was associated with faster and more effective reversal of rocuronium-induced NMB in pediatric patients.