A Prospective, Multi-center, Randomized Controlled Study of Muscle Relaxation Effect and Safety of Mivacurium Chloride in Pediatric Surgery Patients
A Prospective, Multi-center, Randomized Controlled Study of Neuromuscular Blocking Effect and Safety of Mivacurium Chloride in Pediatric Patients
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: group 1
age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 20 s
|
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:
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 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
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
|
|
EXPERIMENTAL: group 2
age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 40 s
|
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:
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 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
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
|
|
EXPERIMENTAL: group 3
age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
|
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:
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 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
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
|
|
EXPERIMENTAL: group 4
age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
|
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:
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 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
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
|
|
EXPERIMENTAL: group 5
age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
|
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:
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 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
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
|
|
EXPERIMENTAL: group 6
age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
|
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:
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 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
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
|
|
EXPERIMENTAL: group 7
age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
|
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:
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 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
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
|
|
EXPERIMENTAL: group 8
age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
|
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:
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 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
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
|
|
EXPERIMENTAL: group 9
age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
|
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:
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 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
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
|
|
EXPERIMENTAL: group 10
age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
|
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:
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 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
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
|
|
EXPERIMENTAL: group 11
age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
|
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:
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 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
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
|
|
EXPERIMENTAL: group 12
age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
|
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:
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 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
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
|
|
EXPERIMENTAL: group 13
age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s
|
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:
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 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
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
|
|
EXPERIMENTAL: group 14
age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s
|
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:
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 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
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
|
|
EXPERIMENTAL: group 15
age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s
|
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:
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 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
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
|
|
EXPERIMENTAL: group 16
age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s
|
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:
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 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
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intubation score
Time Frame: 1 minute within intubation
|
Krieg Tracheal Intubation Score
|
1 minute within intubation
|
|
muscle relaxation effect
Time Frame: from baseline to no more than 120 minutes after intubation
|
|
from baseline to no more than 120 minutes after intubation
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Analgesics, Opioid
- Narcotics
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Neuromuscular Agents
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Ketamine
- Remifentanil
- Midazolam
- Propofol
- Mivacurium
Other Study ID Numbers
- 20121101
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