NCT02117401

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

A Prospective, Multi-center, Randomized Controlled Study of Neuromuscular Blocking Effect and Safety of Mivacurium Chloride in Pediatric Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,152 (actual)
• Sponsor: Jiangsu Nhwa Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 2 Months – 14 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effect and safety of mivacurium chloride in pediatric patients.

Conditions

• Efficacy and Safety of Mivacurium Chloride for Pediatric Patients

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2014-04-21
• Last updated: 2014-07-15