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

NCT02117401 | Completed Phase 4 DMC

• 1 other identifier: 20121101
• Study Type: interventional
• Target: 1,152
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Efficacy and Safety of Mivacurium Chloride for Pediatric Patients

Outcome Measures

Primary Outcomes (2)

• intubation score

  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.

  1 minute within intubation

• muscle relaxation effect

  * 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%

  from baseline to no more than 120 minutes after intubation

Study Arms (16)

group 1

EXPERIMENTAL

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

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

group 2

EXPERIMENTAL

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

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

group 3

EXPERIMENTAL

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

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

group 4

EXPERIMENTAL

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

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

group 5

EXPERIMENTAL

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

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

group 6

EXPERIMENTAL

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

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

group 7

EXPERIMENTAL

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

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

group 8

EXPERIMENTAL

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

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

group 9

EXPERIMENTAL

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

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

group 10

EXPERIMENTAL

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

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

group 11

EXPERIMENTAL

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

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

group 12

EXPERIMENTAL

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

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

group 13

EXPERIMENTAL

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

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

group 14

EXPERIMENTAL

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

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

group 15

EXPERIMENTAL

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

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

group 16

EXPERIMENTAL

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

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

Interventions

mivacurium chloride DRUG

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.

Also known as: mivacron

group 1; group 10; group 11; group 12; group 13; group 14; group 15; group 16; group 2; group 3; group 4; group 5; group 6; group 7; group 8; group 9

midazolam DRUG

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

group 1; group 10; group 11; group 12; group 13; group 14; group 15; group 16; group 2; group 3; group 4; group 5; group 6; group 7; group 8; group 9

ketamine DRUG

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

group 1; group 10; group 11; group 12; group 13; group 14; group 15; group 16; group 2; group 3; group 4; group 5; group 6; group 7; group 8; group 9

propofol DRUG

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

group 1; group 10; group 11; group 12; group 13; group 14; group 15; group 16; group 2; group 3; group 4; group 5; group 6; group 7; group 8; group 9

Remifentanil DRUG

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

group 1; group 10; group 11; group 12; group 13; group 14; group 15; group 16; group 2; group 3; group 4; group 5; group 6; group 7; group 8; group 9

Eligibility Criteria

• Age: 2 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Blood loss more than 10 ml/kg in surgery

Sponsors & Collaborators

• Jiangsu Nhwa Pharmaceutical Co., Ltd.: lead

Related Publications (1)

• Zeng R, Liu X, Zhang J, Yin N, Fei J, Zhong S, Hu Z, Hu M, Zhang M, Li B, Li J, Lian Q, ShangGuan W. The efficacy and safety of mivacurium in pediatric patients. BMC Anesthesiol. 2017 Apr 17;17(1):58. doi: 10.1186/s12871-017-0350-2.

  PMID: 28415988 DERIVED

MeSH Terms

Interventions

Mivacurium; Midazolam; Ketamine; Propofol; Remifentanil

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 21, 2014
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 15, 2014

Record last verified: 2014-07