Abstract
Background: We evaluated the time course of neuromuscular blockade (NMB) of three intubating doses of rocuronium in pediatric patients. Methods: This multicenter, randomized, assessor-blinded study included surgical patients aged 0 to 17 years. Anesthesia was induced with sevoflurane, continued until intubation, and maintained with isoflurane. Neuromuscular function was monitored by acceleromyography. Patients received a rocuronium dose of 0.45, 0.6 or 1.0 mg/kg, and intubation was attempted 60 sec later. Primary outcome variable was time from end of rocuronium administration to reappearance of the third twitch (T3). Time to onset of peak NMB was assessed. Safety assessments included monitoring adverse events. Results: A total of 207 patients were enrolled and randomized. Median times from rocuronium administration to NMB onset were <1.2 minutes in all age groups for each dose in the per-protocol population (n=175). Median time from rocuronium administration to reappearance of T3 ranged from 21 to 114 minutes overall, and was longer in the higher dose groups across age groups, and longer in neonates and infants compared with other age groups. There were no adverse events considered related to rocuronium. Conclusions: Rocuronium at intubating doses of 0.45, 0.6, or 1.0 mg/kg is effective in producing rapid-onset neuromuscular blockade with an intermediate duration of action in pediatric patients during sevoflurane induction/ isoflurane maintenance anesthesia. Longest duration of blockade occurred with the highest dose within all age groups, and in neonates and infants compared with other age groups.
Highlights
There are differences between pediatric and adult patients in the responses to neuromuscular blocking agents (NMBAs), with variations in potency and duration of action having been observed among infants, children, and adults for most NMBAs [1]
Rocuronium is a steroidal nondepolarizing NMBA with a rapid onset and intermediate duration of action, and good tolerability in adults at doses up to 1.2 mg/kg [5,6,7,8], which has been available for use in pediatric patients since 1994
Our study showed that rocuronium at the approved intubating doses of 0.45, 0.6 or 1.0 mg/kg was generally well tolerated, and induced a rapid onset of neuromuscular blockade (NMB), during sevoflurane anesthesia
Summary
There are differences between pediatric and adult patients in the responses to neuromuscular blocking agents (NMBAs), with variations in potency and duration of action having been observed among infants, children, and adults for most NMBAs [1]. There are relatively limited data in pediatric patients, in neonates and young infants, and in pediatric patients undergoing induction of anesthesia with sevoflurane, which is more commonly used in this patient group than more traditional agents such as halothane and propofol. The aim of this multicenter, dose-response study was to evaluate the duration of neuromuscular blockade (NMB) of three intubating doses of rocuronium (the standard 0.6 mg/kg intubating dose, and a dose above [1.0 mg/kg], and below this [0.45 mg/kg]) in pediatric patients during induction of anesthesia with sevoflurane and maintenance with isoflurane. We evaluated the time course of neuromuscular blockade (NMB) of three intubating doses of rocuronium in pediatric patients
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