Propofol Versus Ketamine for Procedural Sedation During Painful Procedures in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Respiratory Depression (Sub-clinical and Clinical Signs)
研究概览
简要总结
This study is a clinical trial of moderate sedation with propofol versus moderate sedation with ketamine for procedural sedation in the Emergency Department.
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
- •patients who require moderate procedural sedation with propofol in the ED
排除标准
- •age > 17 years
- •intoxicated
- •cannot give informed consent
- •allergy to ketamine or propofol
- •patient will require deep procedural sedation
- •ASA physical status score > 2
研究组 & 干预措施
Propofol
propofol 1 milligram per kilogram intravenous bolus followed by 0.5 millligrams per kilogram as needed for mooderate procedural sedation
干预措施: propofol (Drug)
Ketamine
ketamine 1 milligram per kilogram followed by 0.5 millgram per kilogram as needed for moderate procedural sedation
干预措施: Ketamine (Drug)
结局指标
主要结局
Respiratory Depression (Sub-clinical and Clinical Signs)
时间窗: From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes)
binary measure based on the occurrence of an oxygen saturation less than 93 at any time, a change in baseline end tidal co2 \>10 or an absence on capnographic waveform
次要结局
- Time to Return of Baseline Mental Status(from start of procedure until the return of baseline mental status up to 120 minutes)
- Patient Reported Pain or Recall of the Procedure(single measurement immediately after patient returns to baseline mental status after sedation procedure)
- Depth of Sedation(single measurement during sedation procedure)