Efficacy for BRIDION® (sugammadex)
Recovery in pediatric patients
Recovery from rocuronium- or vecuronium-induced NMB in pediatric patients aged 2 to <17 years of age.
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.
Recovery from rocuronium- or vecuronium-induced NMB in pediatric patients from birth to <2 years old.
In a study of randomized pediatric patients from birth to <2 years of age (n=145), BRIDION (vs neostigmine) demonstrated statistically faster recovery from moderate NMB.
These effects were consistent across age cohorts studied (birth to 27 days, 28 days to <3 months, 3 months to <6 months, 6 months to <2 years of age).
Primary efficacy objective: time from start of BRIDION or neostigmine administration to recovery from moderate NMB
Study design
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 145 randomized pediatric patients from birth to <2 years of age, of which 138 patients received treatment (92 boys and 46 girls; ASA class 1, 2, and 3; 68% were White; median weight was 5.8 kg; median age was 100.5 days). The primary efficacy objective was to evaluate the time to neuromuscular recovery of BRIDION in comparison to neostigmine for the reversal of moderate neuromuscular blockade.
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