Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 12, 2019

Primary Completion Date

February 20, 2020

Study Completion Date

February 20, 2020

Conditions
Anesthesia, GeneralNeuromuscular Blockade
Interventions
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

Trial Locations (1)

15710

SNUH, Seoul

All Listed Sponsors
collaborator

Ministry of Food and Drug Safety, Korea

OTHER_GOV

lead

Seoul National University Hospital

OTHER

NCT03943888 - Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children | Biotech Hunter | Biotech Hunter