A Prospective, Multi-center, Randomized Controlled Study of Muscle Relaxation Effect and Safety of Mivacurium Chloride in Pediatric Surgery Patients
Phase 4
Completed
- Conditions
- Efficacy and Safety of Mivacurium Chloride for Pediatric Patients
- Interventions
- Registration Number
- NCT02117401
- Lead Sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
- Brief Summary
To evaluate the effect and safety of mivacurium chloride in pediatric patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1152
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group 1 ketamine age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 20 s group 1 propofol age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 20 s group 1 mivacurium chloride age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 20 s group 11 mivacurium chloride age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s group 11 Remifentanil age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s group 1 midazolam age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 20 s group 1 Remifentanil age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 20 s group 2 mivacurium chloride age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 40 s group 2 midazolam age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 40 s group 2 ketamine age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 40 s group 3 mivacurium chloride age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 2 propofol age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 40 s group 2 Remifentanil age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 40 s group 3 midazolam age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 3 ketamine age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 4 propofol age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 3 propofol age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 4 mivacurium chloride age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 4 ketamine age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 3 Remifentanil age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 4 midazolam age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 4 Remifentanil age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 5 mivacurium chloride age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 5 midazolam age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 5 ketamine age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 6 mivacurium chloride age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 5 propofol age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 5 Remifentanil age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 6 midazolam age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 6 ketamine age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 6 Remifentanil age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 6 propofol age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 7 mivacurium chloride age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s group 7 midazolam age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s group 7 ketamine age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s group 7 propofol age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s group 7 Remifentanil age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s group 8 mivacurium chloride age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s group 8 midazolam age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s group 8 Remifentanil age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s group 8 propofol age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s group 8 ketamine age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s group 9 mivacurium chloride age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 9 midazolam age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 9 ketamine age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 9 propofol age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 9 Remifentanil age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 10 mivacurium chloride age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 10 ketamine age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 10 propofol age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 10 midazolam age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 10 Remifentanil age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 11 midazolam age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s group 11 ketamine age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s group 12 mivacurium chloride age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s group 11 propofol age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s group 12 midazolam age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s group 12 ketamine age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s group 12 propofol age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s group 12 Remifentanil age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s group 13 mivacurium chloride age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 13 midazolam age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 13 propofol age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 13 Remifentanil age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 13 ketamine age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s group 14 mivacurium chloride age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 14 Remifentanil age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 14 midazolam age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 14 ketamine age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 14 propofol age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s group 16 Remifentanil age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s group 15 mivacurium chloride age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s group 15 midazolam age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s group 15 ketamine age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s group 15 propofol age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s group 15 Remifentanil age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s group 16 midazolam age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s group 16 ketamine age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s group 16 mivacurium chloride age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s group 16 propofol age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
- Primary Outcome Measures
Name Time Method 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%
- Secondary Outcome Measures
Name Time Method