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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia; Bronchoscopy; Muscle Relaxants
• Intervention / Treatment: Drug: mivacurium chloride; Drug: succinylcholine

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peng Liang; Phone Number: 18980608961; Email: liangpengwch@scu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mivacurium chloride; mivacurium chloride 0.14 mg/kg induction bolus + 0.5 mg/kg/h maintenance infusion	Drug: mivacurium chloride; mivacurium chloride 0.14 mg/kg induction bolus + 0.5 mg/kg/h maintenance infusion
Active Comparator: succinylcholine; succinylcholine (1 mg/kg induction bolus + 5 mg/kg/h maintenance infusion)	Drug: succinylcholine; succinylcholine (1 mg/kg induction bolus + 5 mg/kg/h maintenance infusion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time of spontaneous breathing	Comparison of recovery times (minutes) for spontaneous breathing between mivacurium chloride and succinylcholine groups. Spontaneous breathing recovery is defined as achieving a tidal volume of 5 ml/kg and a respiratory rate of 12 breaths per minute.	From the end of bronchoscopy until spontaneous breathing, assessed up to 15 minutes post-procedure.
Recovery time of consciousness	Comparison of recovery times (minutes) for consciousness recovery. Consciousness recovery is defined as the ability to open eyes upon verbal command or when called by name.	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	Comparison of time to remove laryngeal mask airway (LMA) between mivacurium chloride and succinylcholine groups.	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	Blood pressure measurements should be taken at 1-minute intervals during the induction phase (pre-LMA insertion), until the LMA is inserted. For the pre-induction phase, post-LMA insertion, surgery start, surgery end, and post-LMA removal, blood pressure should be measured every 3 minutes, with recordings taken for a total of 3 minutes at each stage. The average blood pressure (mmHg) for each stage was calculated using the values recorded during that stage for both the mivacurium chloride and succinylcholine groups.	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	Oxygen saturation (%) recorded for both mivacurium chloride and succinylcholine groups 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.
Heart rate recorded at different stages	Heart rate recorded (beats per minute) at different stages for both mivacurium chloride and succinylcholine groups.	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.

Collaborators and Investigators

• Sponsor: Peng Liang

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Muscle Hypotonia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Neuromuscular Depolarizing Agents; Mivacurium; Succinylcholine
• Other Study ID Numbers: 2024No.1625; ChiCTR (Registry Identifier: ChiCTR2400091276)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No