Efficacy for BRIDION® (sugammadex)
Recovery in pediatric patients
Recovery from rocuronium- or vecuronium-induced NMB in pediatric patients aged 2 years and older.
In a study of randomized pediatric patients 2 to <17 years of age (n=288), BRIDION (vs neostigmine) demonstrated statistically faster recovery to a TOF ratio of ≥0.9 from moderate NMB (reappearance of T2).1
These effects were consistent across age cohorts studied (2 to <6; 6 to <12; 12 to <17 years of age) and NMBA (rocuronium and vecuronium).1
Primary efficacy objective: time from start of BRIDION or neostigmine administration to recovery of a TOF ratio ≥0.9
Study design1
Time to recovery from neuromuscular blockade induced by rocuronium or vecuronium followed by administration of BRIDION or neostigmine was assessed in a randomized, double-blind, active comparator-controlled study. The study was conducted in 288 randomized pediatric patients 2 to <17 years of age, of which 276 patients received treatment (153 boys and 123 girls; ASA class 1, 2, and 3; 89.5% were Caucasian; median weight was 25 kg; median age was 7 years). The primary efficacy objective was to evaluate the effect of BRIDION compared to neostigmine for reversal of moderate neuromuscular blockade as measured by time to recovery to a TOF ratio of ≥0.9.
Abbreviations
- ASA = American Society of Anesthesiologists
- CI = confidence interval
- NMB = neuromuscular blockade
- NMBA = neuromuscular blocking agent
- TOF = train-of-four
Reference
- Voss T, Wang A, DeAngelis M, et al. Sugammadex for reversal of neuromuscular blockade in pediatric patients: Results from a phase IV randomized study. Pediatric Anesthesia. 2022;32:436-445. DOI: 10.1111/pan.14370