Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults : a Blinded, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Proportion of recovery agitation
研究概览
简要总结
Using Ketamine for procedural sedation in adults is often uncomfortable for emergency physicians because of the significant proportion of patients experimenting recovery agitation. The investigators believe that combining propofol to ketamine, the proportion of recovery agitation will be significantly lowered.
The objectives of this double-blinded, randomized controlled trial are to compare the proportion of recovery agitation in adults receiving procedural sedation with ketamine-propofol versus ketamine alone, and to compare the proportion of other classical procedural sedation side-effects and parameters such as respiratory depression, hypotension, sedation duration, time of recovery, procedural failures, and levels of satisfaction.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 years and older
- •indication of procedural sedation
排除标准
- •allergy to propofol or ketamine
- •alcohol or drug intoxication
- •altered mental status
- •ASA physical status score > 2
- •hemodynamic unstability
研究组 & 干预措施
Ketamine-propofol
干预措施: Procedural sedation with ketamine-propofol combination (Drug)
Ketamine alone
干预措施: Procedural sedation with ketamine alone (Drug)
结局指标
主要结局
Proportion of recovery agitation
时间窗: Recovery agitation is noted after procedural sedation for each patient (30 minutes)
Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection
次要结局
- Time from first injection to optimal sedation(Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection (30 minutes))
- Recovery time(Recovery time is assessed after procedural sedation for each patient (30 minutes))
- Proportion of vomiting(vomiting is assessed after procedural sedation for each patient (30 minutes))
- Proportion of procedural failures(Procedural failure is noted for each patient if it's happened (30 minutes))
- Level of patient's satisfaction(after procedural sedation, patient's satisfaction is recorded (30 minutes))
- Proportion of respiratory depression(respiratory depression is assessed during procedural sedation for each patient (30 minutes))
- Proportion of arterial hypotension(Hypotension is assessed during procedural sedation for each patient (30 minutes))
- Level of care giver's satisfaction(after procedural sedation, care giver's satisfaction is recorded (30 minutes))