Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children

This study enrolls pediatric patients undergoing surgery under general anesthesia with need for early reversal of neuromuscular blockade, aged between 2 and 18 years old.

After routine anesthetic induction with 1% propofol and 0.6mg/kg of rocuronium, maintenance of anesthesia with total intravenous anesthesia is commenced. 15 minutes after rocuronium administration, 2 or 4 or 8mg/kg of sugammadex sodium or conventional neuromuscular reversal agent is administered according to randomization table.

For neuromuscular monitoring, train-of-four (TOF) count and T4/T1 ratio are monitored, with recording of the time to recovery of the T4/T1 ratio to 0.7, 0.8 and 0.9.

For pharmacokinetic analysis, patient blood sample is obtained before / 2 min after rocuronium administration, before / 2min / 5min / 15min / 60min / 120min / 240min / 480min after sugammadex administration. Plasma concentration of rocuronium and sugammadex sodium are analyzed via high-performance liquid chromatography with mass spectrometric detection.

Inclusion criteria

All of below

• Pediatric patients undergoing surgery under general anesthesia with requirement of early reversal of neuromuscular blockade
• Aged between 2 and 17
• American Society of Anesthesiologists Physical Status Classification 1 and 2

Exclusion criteria

Any of below

• One or more legal guardian declines to enroll in the study
• History of hypersensitivity to any anesthetic agents including rocuronium
• Presence of underlying cardiovascular or genitourinary disease
• Under usage of neuromuscular blocking agents before surgery
• Under usage of drugs influencing the effect of neuromuscular blocking agents
• History of malignant hyperthermia
• Anticipation of massive hemorrhage during surgery