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Muscle Relaxant Effect and Safety of Mivacurium Chloride and Succinylcholine for Bronchoscopy

NCT ID: NCT06709066

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-20

Study Completion Date

2025-12-31

Brief Summary

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The goal of this clinical trial is to evaluate whether mivacurium chloride and succinylcholine can provide effective and safe muscle relaxation in adult patients aged 18-60 years undergoing bronchoscopy who require muscle relaxants during anesthesia. The main questions it aims to answer are:

* Is the recovery of spontaneous breathing within 15 minutes after drug discontinuation with mivacurium chloride non-inferior to succinylcholine?
* How do mivacurium chloride and succinylcholine compare in terms of intraoperative hemodynamics and post-operative recovery and comfort? Researchers will compare the mivacurium chloride group and the succinylcholine group to observe if mivacurium chloride can provide similar or better recovery effects compared to succinylcholine.

Participants will:

* Receive either mivacurium chloride (0.14 mg/kg induction bolus + 0.5 mg/kg/h maintenance infusion) or succinylcholine (1 mg/kg induction bolus + 5 mg/kg/h maintenance infusion) as a muscle relaxant during bronchoscopy.
* Have their vital signs, including blood pressure, oxygen saturation, and heart rate, monitored at multiple time points during the procedure.
* Be assessed post-procedure for spontaneous breathing recovery, consciousness recovery, and time to laryngeal mask airway (LMA) removal, as well as overall comfort and satisfaction.

Detailed Description

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Conditions

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Anesthesia Bronchoscopy Muscle Relaxants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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mivacurium chloride

mivacurium chloride 0.14 mg/kg induction bolus + 0.5 mg/kg/h maintenance infusion

Group Type EXPERIMENTAL

mivacurium chloride

Intervention Type DRUG

mivacurium chloride 0.14 mg/kg induction bolus + 0.5 mg/kg/h maintenance infusion

succinylcholine

succinylcholine (1 mg/kg induction bolus + 5 mg/kg/h maintenance infusion)

Group Type ACTIVE_COMPARATOR

succinylcholine

Intervention Type DRUG

succinylcholine (1 mg/kg induction bolus + 5 mg/kg/h maintenance infusion)

Interventions

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mivacurium chloride

mivacurium chloride 0.14 mg/kg induction bolus + 0.5 mg/kg/h maintenance infusion

Intervention Type DRUG

succinylcholine

succinylcholine (1 mg/kg induction bolus + 5 mg/kg/h maintenance infusion)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients scheduled for painless bronchoscopy who require muscle relaxants during anesthesia.
2. Aged between 18 and 60 years.
3. Classified as Grade I-III according to the American Society of Anesthesiologists (ASA) Physical Status Classification.
4. Patients voluntarily participate and sign an informed consent form.

Exclusion Criteria

1. Patients with known allergies to any of the drugs involved in the study.
2. Patients with severe organic diseases of the brain, heart, lungs, liver, kidneys, or other major organs.
3. Patients with intracranial hypertension, asthma, cataracts, glaucoma, or other eye diseases.
4. Patients with myasthenia gravis, myasthenic syndrome, severe reduction or deficiency of cholinesterase, upper motor neuron injury, or upper motor neuron diseases that may cause abnormal responses to muscle relaxants.
5. Patients who have used medications affecting neuromuscular transmission function before the procedure.
6. Pregnant or breastfeeding patients.
7. Patients who have experienced extensive burns, acid-base imbalance, or electrolyte disturbances within the past six months.
8. Patients known or suspected to be homozygous for the atypical gene for plasma cholinesterase.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peng Liang

OTHER

Sponsor Role lead

Responsible Party

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Peng Liang

chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Peng Liang

Role: CONTACT

[email protected]
18980608961

Other Identifiers

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ChiCTR

Identifier Type: REGISTRY

Identifier Source: secondary_id

2024No.1625

Identifier Type: -

Identifier Source: org_study_id