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.
A Prospective, Multi-center, Randomized Controlled Study of Muscle Relaxation Effect and Safety of Mivacurium Chloride in Pediatric Surgery Patients
Brief Summary
To evaluate the effect and safety of mivacurium chloride in pediatric patients.
Intervention / Treatment
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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.
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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
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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
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Propofol (DRUG)Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
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Remifentanil (DRUG)Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
Condition or Disease
- Efficacy and Safety of Mivacurium Chloride for Pediatric Patients
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 2 Months to 14 Years |
| Enrollment: | 1152 (ACTUAL) |
| Funded by: | Industry |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
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Clinical Trial Dates
| Start date: | Jan 01, 2012 | |
|---|---|---|
| Primary Completion: | Jun 01, 2013 | ACTUAL |
| Completion Date: | Jun 01, 2013 | ACTUAL |
| Study First Posted: | Apr 21, 2014 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jul 14, 2014 |
Sponsors / Collaborators
Lead Sponsor:
Jiangsu Nhwa Pharmaceutical Co., Ltd.
Lead sponsor is responsible party
Responsible Party:
N/A
Participant Groups
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age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 20 s
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age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 40 s
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age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
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age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
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age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
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age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
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age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
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age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
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age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
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age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
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age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
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age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
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age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
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age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
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age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
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age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
Eligibility Criteria
| Sex: | All |
|---|---|
| Maximum Age: | 14 |
| Age Groups: | Child |
| Healthy Volunteers: | Yes |
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
* 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
Primary Outcomes
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* 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%
More Details
| NCT Number: | NCT02117401 |
|---|---|
| Other IDs: | 20121101 |
| Study URL: | https://clinicaltrials.gov/study/NCT02117401 |
Last updated: Sep 29, 2023