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

Sponsor

Jiangsu Nhwa Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02117401

Collaborator

(none)

1,152

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Efficacy and Safety of Mivacurium Chloride for Pediatric Patients	Drug: mivacurium chloride Drug: midazolam Drug: ketamine Drug: propofol Drug: Remifentanil	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

1152 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group 1 age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 20 s	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. Other Names: mivacron 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
Experimental: group 2 age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 40 s	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. Other Names: mivacron 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
Experimental: group 3 age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s	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. Other Names: mivacron 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
Experimental: group 4 age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s	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. Other Names: mivacron 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
Experimental: group 5 age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s	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. Other Names: mivacron 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
Experimental: group 6 age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s	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. Other Names: mivacron 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
Experimental: group 7 age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s	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. Other Names: mivacron 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
Experimental: group 8 age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s	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. Other Names: mivacron 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
Experimental: group 9 age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s	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. Other Names: mivacron 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
Experimental: group 10 age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s	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. Other Names: mivacron 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
Experimental: group 11 age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s	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. Other Names: mivacron 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
Experimental: group 12 age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s	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. Other Names: mivacron 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
Experimental: group 13 age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s	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. Other Names: mivacron 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
Experimental: group 14 age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s	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. Other Names: mivacron 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
Experimental: group 15 age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s	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. Other Names: mivacron 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
Experimental: group 16 age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s	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. Other Names: mivacron 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

Outcome Measures

Primary Outcome Measures

intubation score [1 minute within intubation]
Krieg Tracheal Intubation Score Score ： 1 2 3 4 Laryngoscopy ： Easy Fair Difficult Impossible Vocal cords： Open Moving Closing Closed Coughing： None Diaphragm Mild Severe A total score of 3-4 = excellent, 5-7 = good, 8-10 = poor, 11-12 = bad.
muscle relaxation effect [from baseline to no more than 120 minutes after intubation]
Recording T1 and TOFR（Train of four ratio) before/after the induction of anesthesia -Onset time of Mivacurium：time from end of injection until occurrence of maxi- mum block Duration of clinical relaxation：time to recovery of Tl(the first response in the TOF) to 25% Recovery index：Time interval during with T1 recovered from 25%

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The parent/guardian must sign a parental permission consent document
American Society of Anesthesiologists (ASA) physical status class 1-3
Elective surgery patients with tracheal intubation, and the operation duration is expected to be longer than 30 min but no longer than 120 min(cleft lip and palate, orthopedic, bilateral hernia, bilateral cryptorchidism, hypospadias crack, and other ear, nose and throat surgery, etc)
Age between 2 months to 14 Years

Exclusion Criteria:

BMI<18kg/m2 or BMI>31kg/m2
Patients with serious respiratory, cardiovascular disease, and liver and kidney dysfunction[AST（glutamic oxalacetic transaminase）,ALT(glutamic-pyruvic transaminase)>1.5 Normal;BUN(blood urea nitrogen)>Normal)]
Patients with asthma or airway hyperresponsiveness, neuromuscular patients disease or cachexia
Preoperative hemoglobin less than 10g/L
Hypoproteinemia TP（total protein) <45g/L
Diabetic patients
Patients with difficulty airway
Patients with Known or suspected atypical plasma cholinesterase gene homozygous
Burn patients
Patients with serious acid-base imbalances, or severe electrolyte imbalance
Patients with neuromuscular relaxants in a week
Patients prohibited with muscle relaxants, or allergy to any component of mivacurium
Patients participated in any drug clinical trial with 30 days before the start of the study
Other situations not suitable for inclusion
Blood loss more than 10 ml/kg in surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Jiangsu Nhwa Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiangsu Nhwa Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02117401

Other Study ID Numbers:

20121101

First Posted:

Apr 21, 2014

Last Update Posted:

Jul 15, 2014

Last Verified:

Jul 1, 2014

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 15, 2014