A Prospective, Multi-center, Randomized Controlled Study of Muscle Relaxation Effect and Safety of Mivacurium Chloride in Pediatric Surgery Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

1,152

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Efficacy and Safety of Mivacurium Chloride for Pediatric Patients
Interventions
DRUG

mivacurium chloride

intravenously injected during induction with the dose according to allocated group, and intravenously injected with the dose of 0.1 mg/kg when T1 recovers to 25% during period of maintenance.

DRUG

midazolam

"Before induction: after moving into operating room, oral administration with dose of 0.5 mg/kg or mixed with ketamine (midazolam 10 mg+ ketamine 100 mg) with dose of 0.1 ml/kg by intramuscular route for uncooperative children~Induction: for children who didn't receive mixture of midazolam and ketamine before induction, it will be given with the dose of 0.05 ml/kg"

DRUG

ketamine

"mixed with ketamine (midazolam 10 mg+ ketamine 100 mg) with dose of 0.1 ml/kg by intramuscular route for uncooperative children~Induction: for children who didn't receive mixture of midazolam and ketamine before induction, it will be given with the dose of 0.05 ml/kg"

DRUG

propofol

Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min

DRUG

Remifentanil

Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min

All Listed Sponsors
lead

Jiangsu Nhwa Pharmaceutical Co., Ltd.

INDUSTRY

NCT02117401 - A Prospective, Multi-center, Randomized Controlled Study of Muscle Relaxation Effect and Safety of Mivacurium Chloride in Pediatric Surgery Patients | Biotech Hunter | Biotech Hunter