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

NCT06709066 | Not Yet Recruiting DMC

• 2 other identifiers: 2024No.1625ChiCTR
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anesthesia; Bronchoscopy; Muscle Relaxants

Outcome Measures

Primary Outcomes (1)

• Rate of spontaneous breathing recovery

  The rate of spontaneous breathing recovery after discontinuation of mivacurium chloride and succinylcholine during bronchoscopy.

  Within 15 minutes after the completion of bronchoscopy.

Secondary Outcomes (6)

• Recovery time of spontaneous breathing

  From the end of bronchoscopy until spontaneous breathing, assessed up to 15 minutes post-procedure.

• Recovery time of consciousness

  From the end of bronchoscopy until each specific recovery milestone is achieved, assessed up to 15 minutes post-procedure.

• Laryngeal mask airway (LMA) removal time

  From the end of bronchoscopy until each specific recovery milestone is achieved, assessed up to 15 minutes post-procedure.

• Mean pulse pressure at different stages

  3 minutes before induction, 1-minute intervals during induction until the LMA is inserted, 3 minutes after LMA insertion, 3 minutes after surgery start, 3 minutes after surgery end, and 3 minutes after LMA removal.

• Oxygen saturation (%) recorded at different stages

  3 minutes before induction, 1-minute intervals during induction until the LMA is inserted, 3 minutes after LMA insertion, 3 minutes after surgery start, 3 minutes after surgery end, and 3 minutes after LMA removal.

Study Arms (2)

mivacurium chloride

EXPERIMENTAL

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

Drug: mivacurium chloride

succinylcholine

ACTIVE COMPARATOR

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

Drug: succinylcholine

Interventions

mivacurium chloride DRUG

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

mivacurium chloride

succinylcholine DRUG

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

succinylcholine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients with known allergies to any of the drugs involved in the study.
• Patients with severe organic diseases of the brain, heart, lungs, liver, kidneys, or other major organs.
• Patients with intracranial hypertension, asthma, cataracts, glaucoma, or other eye diseases.
• 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.
• Patients who have used medications affecting neuromuscular transmission function before the procedure.
• Pregnant or breastfeeding patients.
• Patients who have experienced extensive burns, acid-base imbalance, or electrolyte disturbances within the past six months.
• Patients known or suspected to be homozygous for the atypical gene for plasma cholinesterase.

Sponsors & Collaborators

• Peng Liang: lead

Related Publications (1)

• Zhang X, Xu Y, Li J, Xi Y, Xu Z, Liang P. Effect and safety of mivacurium chloride and succinylcholine for bronchoscopy: study protocol for a single-center, randomized, non-inferiority, and positive-controlled clinical trial. Trials. 2026 Jan 22. doi: 10.1186/s13063-026-09463-3. Online ahead of print.

  PMID: 41566470 DERIVED

MeSH Terms

Conditions

Muscle Hypotonia

Interventions

Mivacurium; Succinylcholine

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds

Central Study Contacts

Peng Liang

CONTACT

18980608961; liangpengwch@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: November 29, 2024
• Study Start: November 20, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share