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

Jiangsu Nhwa Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Efficacy and Safety of Mivacurium Chloride for Pediatric Patients

Treatments: Drug: ketamine; Drug: Remifentanil; Drug: midazolam; Drug: propofol; Drug: mivacurium chloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT02117401

20121101

Details and patient eligibility

About

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

Enrollment: 1,152 patients

Sex: All

Ages: 2 months to 14 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,152 participants in 16 patient groups

group 1

Experimental group

Description:

age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 20 s

Treatment:

Drug: mivacurium chloride

Drug: midazolam

Drug: Remifentanil

Drug: ketamine

Drug: propofol

group 2

Experimental group

Description:

age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 40 s

Treatment:

Drug: mivacurium chloride

Drug: midazolam

Drug: Remifentanil

Drug: ketamine

Drug: propofol

group 3

Experimental group

Description:

age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s

Treatment:

Drug: mivacurium chloride

Drug: midazolam

Drug: Remifentanil

Drug: ketamine

Drug: propofol

group 4

Experimental group

Description:

age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s

Treatment:

Drug: mivacurium chloride

Drug: midazolam

Drug: Remifentanil

Drug: ketamine

Drug: propofol

group 5

Experimental group

Description:

age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s

Treatment:

Drug: mivacurium chloride

Drug: midazolam

Drug: Remifentanil

Drug: ketamine

Drug: propofol

group 6

Experimental group

Description:

age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s

Treatment:

Drug: mivacurium chloride

Drug: midazolam

Drug: Remifentanil

Drug: ketamine

Drug: propofol

group 7

Experimental group

Description:

age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s

Treatment:

Drug: mivacurium chloride

Drug: midazolam

Drug: Remifentanil

Drug: ketamine

Drug: propofol

group 8

Experimental group

Description:

age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s

Treatment:

Drug: mivacurium chloride

Drug: midazolam

Drug: Remifentanil

Drug: ketamine

Drug: propofol

group 9

Experimental group

Description:

age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s

Treatment:

Drug: mivacurium chloride

Drug: midazolam

Drug: Remifentanil

Drug: ketamine

Drug: propofol

group 10

Experimental group

Description:

age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s

Treatment:

Drug: mivacurium chloride

Drug: midazolam

Drug: Remifentanil

Drug: ketamine

Drug: propofol

group 11

Experimental group

Description:

age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s

Treatment:

Drug: mivacurium chloride

Drug: midazolam

Drug: Remifentanil

Drug: ketamine

Drug: propofol

group 12

Experimental group

Description:

age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s

Treatment:

Drug: mivacurium chloride

Drug: midazolam

Drug: Remifentanil

Drug: ketamine

Drug: propofol

group 13

Experimental group

Description:

age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s

Treatment:

Drug: mivacurium chloride

Drug: midazolam

Drug: Remifentanil

Drug: ketamine

Drug: propofol

group 14

Experimental group

Description:

age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s

Treatment:

Drug: mivacurium chloride

Drug: midazolam

Drug: Remifentanil

Drug: ketamine

Drug: propofol

group 15

Experimental group

Description:

age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s

Treatment:

Drug: mivacurium chloride

Drug: midazolam

Drug: Remifentanil

Drug: ketamine

Drug: propofol

group 16

Experimental group

Description:

age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s

Treatment:

Drug: mivacurium chloride

Drug: midazolam

Drug: Remifentanil

Drug: ketamine

Drug: propofol