The Effect and Safety of Different Sedation Strategies for Diagnostic Bronchoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cough score
研究概览
简要总结
Diagnostic bronchoscopy is an invasive procedure performed to diagnose respiratory diseases. But pain has been complained by most of the patients receiving such procedures. Sedation or anesthesia was required by both of the patients and bronchoscopists. Unfortunately, no consensus has been made upon the sedation strategies. Multiple sedation approaches have been applied, such as midazolam and fentanyl, remifentanil and propofol, dexmedetomidine and propofol. The present study was designed to compare these protocols in sedation for diagnostic bronchoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for flexible diagnostic bronchoscopy
- •Adult patients aged 18 to 65 years
- •American Society of Anesthesiologists (ASA) Physical Status Classification I-II
- •BMI 18.5-25kg/m2
- •Subjects provide informed consent
排除标准
- •Severe airway obstruction
- •Coagulation disorder
- •Repeat bronchoscopy (more than 3 times)
- •Severe liver and renal dysfunction
- •Cardiovascular and cerebrovascular diseases
- •Pregnancy
- •Chronic opioid user
- •Drug abusers or addicts
研究组 & 干预措施
F
Sedated with intravenous midazolam (0.03mg/kg) and fentanyl (1μg/kg) for induction and maintenance
干预措施: Midazolam (Drug)
F
Sedated with intravenous midazolam (0.03mg/kg) and fentanyl (1μg/kg) for induction and maintenance
干预措施: Fentanyl (Drug)
DR
Sedated with intravenous midazolam (0.03mg/kg), dexmedetomidine (0.5-1μg/kg for induction+0.5-0.7μg/kg/h for maintenance) and remifentanil (plasma concentration 2.0-2.5ng/ml) for induction and maintenance
干预措施: Midazolam (Drug)
DR
Sedated with intravenous midazolam (0.03mg/kg), dexmedetomidine (0.5-1μg/kg for induction+0.5-0.7μg/kg/h for maintenance) and remifentanil (plasma concentration 2.0-2.5ng/ml) for induction and maintenance
干预措施: Dexmedetomidine (Drug)
DR
Sedated with intravenous midazolam (0.03mg/kg), dexmedetomidine (0.5-1μg/kg for induction+0.5-0.7μg/kg/h for maintenance) and remifentanil (plasma concentration 2.0-2.5ng/ml) for induction and maintenance
干预措施: Remifentanil (Drug)
DF
Sedated with intravenous midazolam (0.03mg/kg), dexmedetomidine (0.5-1μg/kg for induction+0.5-0.7μg/kg/h for maintenance) and fentanyl (1μg/kg) for induction and maintenance
干预措施: Midazolam (Drug)
DF
Sedated with intravenous midazolam (0.03mg/kg), dexmedetomidine (0.5-1μg/kg for induction+0.5-0.7μg/kg/h for maintenance) and fentanyl (1μg/kg) for induction and maintenance
干预措施: Fentanyl (Drug)
DF
Sedated with intravenous midazolam (0.03mg/kg), dexmedetomidine (0.5-1μg/kg for induction+0.5-0.7μg/kg/h for maintenance) and fentanyl (1μg/kg) for induction and maintenance
干预措施: Dexmedetomidine (Drug)
PR
Sedated with intravenous midazolam (0.03mg/kg), propofol (plasma concentration 1.0-2.0ng/ml) and remifentanil (plasma concentration 2.0-2.5ng/ml) for induction and maintenance
干预措施: Midazolam (Drug)
PR
Sedated with intravenous midazolam (0.03mg/kg), propofol (plasma concentration 1.0-2.0ng/ml) and remifentanil (plasma concentration 2.0-2.5ng/ml) for induction and maintenance
干预措施: Remifentanil (Drug)
PR
Sedated with intravenous midazolam (0.03mg/kg), propofol (plasma concentration 1.0-2.0ng/ml) and remifentanil (plasma concentration 2.0-2.5ng/ml) for induction and maintenance
干预措施: Propofol (Drug)
结局指标
主要结局
Cough score
时间窗: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours
Cough score across the procedure will be classified into 4 degree (1-4) as follows. 1 = none, 2 = one gag or cough only, 3 = \>1 gag or cough, but acceptable conditions, 4 = unacceptable conditions
次要结局
- Amount of the rescue use of propofol(After sedation induction, assessed up to 2 hours)
- Recovery time(After termination of the sedation medication, assessed up to 2 hours)
- Prevalence of the side effects of respiratory and circulatory system(Across the sedation duration, assessed up to 2 hours)
- Body movement(From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours)
- Satisfaction score of the patients and bronchoscopists(Across the procedure, assessed up to 2 hours)
研究者
Jia-feng Wang
Clinical Professor
Changhai Hospital