Efficacy and Safety of Mivacurium Chloride for Pediatric PatientsPhase 4NCT02117401
A Prospective, Multi-center, Randomized Controlled Study of Muscle Relaxation Effect and Safety of Mivacurium Chloride in Pediatric Surgery Patients
A Phase 4 study testing mivacurium chloride, midazolam and ketamine in people with Efficacy and Safety of Mivacurium Chloride for Pediatric Patients, run by Jiangsu Nhwa Pharmaceutical Co., Ltd..
Trial summary
To evaluate the effect and safety of mivacurium chloride in pediatric patients. Read more about this study
- Who is it for?
- Ages 2 months to 14 years
- Conditions the study is for
- Efficacy and Safety of Mivacurium Chloride for Pediatric Patients
- What is being tested?
- mivacurium chloride, midazolam and ketamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,152 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
About this study
Official title: A Prospective, Multi-center, Randomized Controlled Study of Neuromuscular Blocking Effect and Safety of Mivacurium Chloride in Pediatric Patients
To evaluate the effect and safety of mivacurium chloride in pediatric patients.
- Being tested
- mivacurium chloride, midazolam, ketamine, propofol, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mivacurium chlorideDrug
Also called mivacron
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.
midazolamDrug
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
ketamineDrug
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
propofolDrug
Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
RemifentanilDrug
Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 20 s Receives: Drug: mivacurium chloride; Drug: midazolam; Drug: ketamine; Drug: propofol; Drug: Remifentanil |
| group 2 | Experimental | age: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 40 s Receives: Drug: mivacurium chloride; Drug: midazolam; Drug: ketamine; Drug: propofol; Drug: Remifentanil |
| group 3 | Experimental | age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s Receives: Drug: mivacurium chloride; Drug: midazolam; Drug: ketamine; Drug: propofol; Drug: Remifentanil |
| group 4 | Experimental | age: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s Receives: Drug: mivacurium chloride; Drug: midazolam; Drug: ketamine; Drug: propofol; Drug: Remifentanil |
| group 5 | Experimental | age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s Receives: Drug: mivacurium chloride; Drug: midazolam; Drug: ketamine; Drug: propofol; Drug: Remifentanil |
| group 6 | Experimental | age: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s Receives: Drug: mivacurium chloride; Drug: midazolam; Drug: ketamine; Drug: propofol; Drug: Remifentanil |
| group 7 | Experimental | age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s Receives: Drug: mivacurium chloride; Drug: midazolam; Drug: ketamine; Drug: propofol; Drug: Remifentanil |
| group 8 | Experimental | age: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s Receives: Drug: mivacurium chloride; Drug: midazolam; Drug: ketamine; Drug: propofol; Drug: Remifentanil |
| group 9 | Experimental | age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s Receives: Drug: mivacurium chloride; Drug: midazolam; Drug: ketamine; Drug: propofol; Drug: Remifentanil |
| group 10 | Experimental | age: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s Receives: Drug: mivacurium chloride; Drug: midazolam; Drug: ketamine; Drug: propofol; Drug: Remifentanil |
| group 11 | Experimental | age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s Receives: Drug: mivacurium chloride; Drug: midazolam; Drug: ketamine; Drug: propofol; Drug: Remifentanil |
| group 12 | Experimental | age: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s Receives: Drug: mivacurium chloride; Drug: midazolam; Drug: ketamine; Drug: propofol; Drug: Remifentanil |
| group 13 | Experimental | age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s Receives: Drug: mivacurium chloride; Drug: midazolam; Drug: ketamine; Drug: propofol; Drug: Remifentanil |
| group 14 | Experimental | age: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s Receives: Drug: mivacurium chloride; Drug: midazolam; Drug: ketamine; Drug: propofol; Drug: Remifentanil |
| group 15 | Experimental | age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s Receives: Drug: mivacurium chloride; Drug: midazolam; Drug: ketamine; Drug: propofol; Drug: Remifentanil |
| group 16 | Experimental | age: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s Receives: Drug: mivacurium chloride; Drug: midazolam; Drug: ketamine; Drug: propofol; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation score
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.
Measured: 1 minute within intubation
muscle relaxation effect
- 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%
Measured: from baseline to no more than 120 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Efficacy and Safety of Mivacurium Chloride for Pediatric PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117401
- Sponsor's protocol ID
- 20121101
- Status last verified
- Jul 2014
- First submitted
- 14 Apr 2014
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zeng R, Liu X, Zhang J, Yin N, Fei J, Zhong S, Hu Z, Hu M, Zhang M, Li B, Li J, Lian Q, ShangGuan W. The efficacy and safety of mivacurium in pediatric patients. BMC Anesthesiol. 2017 Apr 17;17(1):58. doi: 10.1186/s12871-017-0350-2.
PubMed 28415988
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Controlled Study of Neuromuscular Blocking Effect and Safety of Mivacurium Chloride in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02117401
- Acronym / sponsor ID
- 20121101
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,152 participants (actual)
- Lead sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect and safety of mivacurium chloride in pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: mivacurium chloride, Drug: midazolam, Drug: ketamine, Drug: propofol, Drug: Remifentanilage: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 20 s |
| group 2 | Experimental | Drug: mivacurium chloride, Drug: midazolam, Drug: ketamine, Drug: propofol, Drug: Remifentanilage: 2 to 12 months induction dosage of mivacurium chloride: 0.15 mg/kg administration: intravenous injection for 40 s |
| group 3 | Experimental | Drug: mivacurium chloride, Drug: midazolam, Drug: ketamine, Drug: propofol, Drug: Remifentanilage: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s |
| group 4 | Experimental | Drug: mivacurium chloride, Drug: midazolam, Drug: ketamine, Drug: propofol, Drug: Remifentanilage: 2 to 12 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s |
| group 5 | Experimental | Drug: mivacurium chloride, Drug: midazolam, Drug: ketamine, Drug: propofol, Drug: Remifentanilage: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s |
| group 6 | Experimental | Drug: mivacurium chloride, Drug: midazolam, Drug: ketamine, Drug: propofol, Drug: Remifentanilage: 13 to 35 months induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s |
| group 7 | Experimental | Drug: mivacurium chloride, Drug: midazolam, Drug: ketamine, Drug: propofol, Drug: Remifentanilage: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s |
| group 8 | Experimental | Drug: mivacurium chloride, Drug: midazolam, Drug: ketamine, Drug: propofol, Drug: Remifentanilage: 13 to 35 months induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s |
| group 9 | Experimental | Drug: mivacurium chloride, Drug: midazolam, Drug: ketamine, Drug: propofol, Drug: Remifentanilage: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s |
| group 10 | Experimental | Drug: mivacurium chloride, Drug: midazolam, Drug: ketamine, Drug: propofol, Drug: Remifentanilage: 3 to 6 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s |
| group 11 | Experimental | Drug: mivacurium chloride, Drug: midazolam, Drug: ketamine, Drug: propofol, Drug: Remifentanilage: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s |
| group 12 | Experimental | Drug: mivacurium chloride, Drug: midazolam, Drug: ketamine, Drug: propofol, Drug: Remifentanilage: 3 to 6 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s |
| group 13 | Experimental | Drug: mivacurium chloride, Drug: midazolam, Drug: ketamine, Drug: propofol, Drug: Remifentanilage: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 20 s |
| group 14 | Experimental | Drug: mivacurium chloride, Drug: midazolam, Drug: ketamine, Drug: propofol, Drug: Remifentanilage: 7 to 14 years induction dosage of mivacurium chloride: 0.20 mg/kg administration: intravenous injection for 40 s |
| group 15 | Experimental | Drug: mivacurium chloride, Drug: midazolam, Drug: ketamine, Drug: propofol, Drug: Remifentanilage: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 20 s |
| group 16 | Experimental | Drug: mivacurium chloride, Drug: midazolam, Drug: ketamine, Drug: propofol, Drug: Remifentanilage: 7 to 14 years induction dosage of mivacurium chloride: 0.25 mg/kg administration: intravenous injection for 40 s |
Who may qualify
- Ages
- 2 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mivacurium chlorideAlso: mivacronintravenously 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. | Drug | group 1, group 10, group 11, group 12, group 13, group 14, group 15, group 16, group 2, group 3, group 4, group 5, group 6, group 7, group 8, group 9 |
| midazolamBefore 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 | Drug | group 1, group 10, group 11, group 12, group 13, group 14, group 15, group 16, group 2, group 3, group 4, group 5, group 6, group 7, group 8, group 9 |
| ketaminemixed 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 | Drug | group 1, group 10, group 11, group 12, group 13, group 14, group 15, group 16, group 2, group 3, group 4, group 5, group 6, group 7, group 8, group 9 |
| propofolInduction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min | Drug | group 1, group 10, group 11, group 12, group 13, group 14, group 15, group 16, group 2, group 3, group 4, group 5, group 6, group 7, group 8, group 9 |
| RemifentanilInduction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min | Drug | group 1, group 10, group 11, group 12, group 13, group 14, group 15, group 16, group 2, group 3, group 4, group 5, group 6, group 7, group 8, group 9 |
Primary outcome
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.
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%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
- Derived from this study: PubMed 28415988Zeng R, Liu X, Zhang J, Yin N, Fei J, Zhong S, Hu Z, Hu M, Zhang M, Li B, Li J, Lian Q, ShangGuan W. The efficacy and safety of mivacurium in pediatric patients. BMC Anesthesiol. 2017 Apr 17;17(1):58. doi: 10.1186/s12871-017-0350-2.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mivacurium chloride, midazolam and ketamine in people with Efficacy and Safety of Mivacurium Chloride for Pediatric Patients, run by Jiangsu Nhwa Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intubation score (time frame: 1 minute within intubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02117401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.