NCT06709066尚未招募不适用
Muscle Relaxant Effect and Safety of Mivacurium Chloride and Succinylcholine for Bronchoscopy
Peng Liang0 个研究点目标入组 240 人开始时间: 2024年11月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 主要终点
- Rate of spontaneous breathing recovery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
mivacurium chloride
Experimental
mivacurium chloride 0.14 mg/kg induction bolus + 0.5 mg/kg/h maintenance infusion
干预措施: mivacurium chloride (Drug)
succinylcholine
Active Comparator
succinylcholine (1 mg/kg induction bolus + 5 mg/kg/h maintenance infusion)
干预措施: succinylcholine (Drug)
结局指标
主要结局
Rate of spontaneous breathing recovery
时间窗: Within 15 minutes after the completion of bronchoscopy.
The rate of spontaneous breathing recovery after discontinuation of mivacurium chloride and succinylcholine during bronchoscopy.
次要结局
- 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.)
- Heart rate 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.)
研究者
Peng Liang
chief physician
West China Hospital
相似试验
已完成
1 期
Sex-related Differences in the Response to the Muscle Relaxant Drug MivacuriumMuscle RelaxationSexNCT01906528University of California, San Francisco20
Unknown
2 期
Mivacurium Chloramine Muscle Relaxation Effect in Patients With Liver CirrhosisLiver DysfunctionNCT02473601Tang-Du Hospital80
招募中
不适用
Evaluation of Effectiveness of Two Different Doses of Mivacurium in Rapid Sequence IntubationEmergenciesNCT06072534Al-Azhar University100
已完成
不适用
Low Dose Mivacurium vs. Low Dose Succinylcholine for Rigid BronchoscopyIntubating ConditionsPerformance With Respiratory Exercise DevicePostoperative MyalgiaNCT01966484Dr. Horst Schmidt Klinik GmbH100
Unknown
4 期
Evaluation of Atracurium-vecuronium Combination in Laparosocpic SurgeryPatients Undergoing Laparoscopic SurgeryNCT03371953Sir Ganga Ram Hospital48