A Prospective, Multi-center, Randomized Controlled Study of Neuromuscular Blocking Effect and Safety of Mivacurium Chloride in Pediatric Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,152
- 主要终点
- intubation score
研究概览
简要总结
To evaluate the effect and safety of mivacurium chloride in pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Months 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
group 1
age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 20 s
干预措施: mivacurium chloride (Drug)
group 1
age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 20 s
干预措施: midazolam (Drug)
group 1
age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 20 s
干预措施: ketamine (Drug)
group 1
age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 20 s
干预措施: propofol (Drug)
group 1
age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 20 s
干预措施: Remifentanil (Drug)
group 2
age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 40 s
干预措施: mivacurium chloride (Drug)
group 2
age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 40 s
干预措施: midazolam (Drug)
group 2
age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 40 s
干预措施: ketamine (Drug)
group 2
age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 40 s
干预措施: propofol (Drug)
group 2
age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 40 s
干预措施: Remifentanil (Drug)
group 3
age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: mivacurium chloride (Drug)
group 3
age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: midazolam (Drug)
group 3
age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: ketamine (Drug)
group 3
age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: propofol (Drug)
group 3
age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: Remifentanil (Drug)
group 4
age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: mivacurium chloride (Drug)
group 4
age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: midazolam (Drug)
group 4
age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: ketamine (Drug)
group 4
age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: propofol (Drug)
group 4
age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: Remifentanil (Drug)
group 5
age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: mivacurium chloride (Drug)
group 5
age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: midazolam (Drug)
group 5
age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: ketamine (Drug)
group 5
age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: propofol (Drug)
group 5
age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: Remifentanil (Drug)
group 6
age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: mivacurium chloride (Drug)
group 6
age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: midazolam (Drug)
group 6
age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: ketamine (Drug)
group 6
age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: propofol (Drug)
group 6
age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: Remifentanil (Drug)
group 7
age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
干预措施: mivacurium chloride (Drug)
group 7
age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
干预措施: midazolam (Drug)
group 7
age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
干预措施: ketamine (Drug)
group 7
age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
干预措施: propofol (Drug)
group 7
age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
干预措施: Remifentanil (Drug)
group 8
age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
干预措施: mivacurium chloride (Drug)
group 8
age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
干预措施: midazolam (Drug)
group 8
age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
干预措施: ketamine (Drug)
group 8
age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
干预措施: propofol (Drug)
group 8
age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
干预措施: Remifentanil (Drug)
group 9
age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: mivacurium chloride (Drug)
group 9
age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: midazolam (Drug)
group 9
age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: ketamine (Drug)
group 9
age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: propofol (Drug)
group 9
age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: Remifentanil (Drug)
group 10
age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: mivacurium chloride (Drug)
group 10
age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: midazolam (Drug)
group 10
age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: ketamine (Drug)
group 10
age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: propofol (Drug)
group 10
age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: Remifentanil (Drug)
group 11
age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
干预措施: mivacurium chloride (Drug)
group 11
age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
干预措施: midazolam (Drug)
group 11
age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
干预措施: ketamine (Drug)
group 11
age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
干预措施: propofol (Drug)
group 11
age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
干预措施: Remifentanil (Drug)
group 12
age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
干预措施: mivacurium chloride (Drug)
group 12
age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
干预措施: midazolam (Drug)
group 12
age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
干预措施: ketamine (Drug)
group 12
age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
干预措施: propofol (Drug)
group 12
age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
干预措施: Remifentanil (Drug)
group 13
age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: mivacurium chloride (Drug)
group 13
age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: midazolam (Drug)
group 13
age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: ketamine (Drug)
group 13
age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: propofol (Drug)
group 13
age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
干预措施: Remifentanil (Drug)
group 14
age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: mivacurium chloride (Drug)
group 14
age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: midazolam (Drug)
group 14
age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: ketamine (Drug)
group 14
age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: propofol (Drug)
group 14
age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
干预措施: Remifentanil (Drug)
group 15
age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
干预措施: mivacurium chloride (Drug)
group 15
age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
干预措施: midazolam (Drug)
group 15
age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
干预措施: ketamine (Drug)
group 15
age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
干预措施: propofol (Drug)
group 15
age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
干预措施: Remifentanil (Drug)
group 16
age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
干预措施: mivacurium chloride (Drug)
group 16
age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
干预措施: midazolam (Drug)
group 16
age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
干预措施: ketamine (Drug)
group 16
age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
干预措施: propofol (Drug)
group 16
age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
干预措施: Remifentanil (Drug)
结局指标
主要结局
intubation score
时间窗: 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
时间窗: 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%
次要结局
未报告次要终点