Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure
研究概览
简要总结
This is a clinical trial of propofol and alfentanil as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ED).
详细描述
This was initially going to be a trial of propofol vs alfentanil vs nitrous oxide, but our use of nitrous oxide was discontinued before the trial began and the trial was conducted with only two arms
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
- None
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
- •Adults undergoing moderate procedural sedation in the Emergency Department
排除标准
- •Age <18 years
- •Pregnancy
- •Intoxication
- •Cannot give informed consent
- •Allergy to any of the three study medications
- •ASA physical status score > 2
- •Patients who require deep procedural sedation
研究组 & 干预措施
Propofol
Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation
干预措施: Propofol (Drug)
Alfentanil
Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation
干预措施: Alfentanil (Drug)
结局指标
主要结局
Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure
时间窗: From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration)
次要结局
- Depth of Sedation Measured Using the OAAS Scale(Single measurement during sedation procedure)
- Patient Reported Pain(Single measurement immediately after patient returns to baseline mental status after sedation procedure)
- Patient Reported Recall of the Procedure(Single measurement immediately after patient returns to baseline mental status after sedation procedure)
- Time to Return of Baseline Mental Status From Start of Procedure in Minutes(Single time point after completion of sedation procedure, measured from start of procedure until the patient returns to baseline mental status up to 24 hours)