Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl-sedation for Flexible Bronchoscopy: A Randomized, Single Blind, Controlled Study of Satisfaction and Safety.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Satisfaction with sedation
研究概览
简要总结
Flexible bronchoscopy almost always requires sedation to be successful. In order to increase the availability of propofol for sedation, non-anaesthesiologist administered propofol sedation has been suggested as an alternative to traditional midazolam/opioid sedation or the general anaesthesia provided by anaesthesiologists.
Hypothesis: Patients undergoing flexible bronchoscopy prefers non-anaesthesiologist administered sedation with propofol as opposed to non-anaesthesiologist administered sedation with midazolam and fentanyl.
Propofol sedation is as safe as midazolam and fentanyl sedation.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective flexible bronchoscopy.
- •Willing to be randomised
- •Provide written informed consent
排除标准
- •Allergy to contents administered
- •pregnant or nursing
- •<18 years of age
- •Not able to complete questionnaire
- •Acute condition
- •severe COPD
- •Sleep apnea
- •Risk of aspiration
- •Previously difficulty with anesthesia
- •Difficult airway
研究组 & 干预措施
Propofol sedation
Refract bolus propofol sedation as monotherapy administered by a sedation-trained nurse endoscopist.
Induction with 10-60 mg bolus, repeated every 45-60 sec. until moderate sedation.
Maintenance with 10-20 mg of propofol in case of discomfort.
干预措施: Propofol sedation (Drug)
Midazolam and Fentanyl sedation
1-2 mg of Midazolam with 0.025-0.05 mg of fentanyl for induction 10 prior to procedure initiation.
Maintenance with 1 mg Midazolam in case of discomfort.
干预措施: Midazolam and Fentanyl sedation (Drug)
结局指标
主要结局
Satisfaction with sedation
时间窗: At discharge, on average 30 minutes after procedure termination.
The average duration of bronchoscopy is estimated to 20 minutes. A validated satisfaction questionnaire will be filled by the patient at discharge from the recovery room, on average 30 minutes after completed procedure. Readiness for discharge will be assessed using an Aldrete score.
次要结局
- Number of adverse events as a surrogate marker of safety.(During procedure. On average 20 minutes.)