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Completed

NCT Number: NCT02117401

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

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

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Key information

Conditions

Efficacy and Safety of Mivacurium Chloride for Pediatric Patients

Age range

2 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: mivacron

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

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

Propofol

Drug

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

Remifentanil

Drug

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

Primary outcomes

  1. intubation score

    Time frame: 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.

  2. muscle relaxation effect

    Time frame: 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%

Sponsors and collaborators

Lead sponsor

Jiangsu Nhwa Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 21, 2014
Registry last updated
Jul 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.