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AnesthesiaNCT06709066

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

A study testing mivacurium chloride and succinylcholine in people with Anesthesia and Bronchoscopy, run by Peng Liang.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Anesthesia, Bronchoscopy, Muscle Relaxants
What is being tested?
mivacurium chloride and succinylcholine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
No sites listed yet
Study dates
20 Nov 2024to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

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.
Read more

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.
Being tested
mivacurium chloride, succinylcholine
Medical subject headings
Muscle Hypotonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mivacurium chlorideDrug

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

  • succinylcholineDrug

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

Study groups in NCT06709066
Study groupRoleWhat they receive
mivacurium chlorideExperimentalmivacurium chloride 0.14 mg/kg induction bolus + 0.5 mg/kg/h maintenance infusion
Receives: Drug: mivacurium chloride
succinylcholineActive comparatorsuccinylcholine (1 mg/kg induction bolus + 5 mg/kg/h maintenance infusion)
Receives: Drug: succinylcholine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of spontaneous breathing recovery

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

    Measured: Within 15 minutes after the completion of bronchoscopy.

Secondary outcomes (6)
  1. 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.

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

  2. 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.

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

  3. Laryngeal mask airway (LMA) removal time

    Comparison of time to remove laryngeal mask airway (LMA) between mivacurium chloride and succinylcholine groups.

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

  4. 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.

    Measured: 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.

  5. Oxygen saturation (%) recorded at different stages

    Oxygen saturation (%) recorded for both mivacurium chloride and succinylcholine groups at different stages.

    Measured: 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.

  6. Heart rate recorded at different stages

    Heart rate recorded (beats per minute) at different stages for both mivacurium chloride and succinylcholine groups.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2024
  2. Study start20 Nov 2024 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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 N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06709066
Sponsor's protocol ID
2024No.1625
Other IDs
ChiCTR
Status last verified
Nov 2024
First submitted
17 Oct 2024
Last updated
29 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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;27(1):137. doi: 10.1186/s13063-026-09463-3.

    PubMed 41566470

Questions about this trial

What is this clinical trial studying?

A study testing mivacurium chloride and succinylcholine in people with Anesthesia and Bronchoscopy, run by Peng Liang.

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 8 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: opening soon, as of the sponsor's last update on 29 Nov 2024. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Peng Liang (18980608961, liangpengwch@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of spontaneous breathing recovery (time frame: Within 15 minutes after the completion of bronchoscopy.). 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 NCT06709066, 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 29 Nov 2024.

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