NCT03943888

Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children

Pharmacokinetic-pharmacodynamic Analysis of Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study administers sugammadex sodium to pediatric patients under general anesthesia with rocuronium. Pharmacokinetic and pharmacodynamic analysis are performed based on plasma concentration of sugammadex sodium and monitoring of neuromuscular blockade.

Detailed description

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.

Conditions

• Anesthesia, General
• Neuromuscular Blockade

Interventions

Type	Name	Description
DRUG	Sugammadex Injection 2mg/kg	Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration
DRUG	Sugammadex Injection 4mg/kg	Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration
DRUG	Sugammadex Injection 8mg/kg	Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration
DRUG	Neuromuscular reversal agent injection	Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine

Timeline

• Start date: 2019-08-12
• Primary completion: 2020-02-20
• Completion: 2020-02-20
• First posted: 2019-05-09
• Last updated: 2022-11-14
• Results posted: 2022-11-14

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study