Randomized Blinded Three Arm Trial of Propofol, 1:1 Combination of Propofol and Ketamine, and 4:1 Combination of Propofol and Ketamine for Procedural Sedation in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 271
- 试验地点
- 1
- 主要终点
- Clinical Interventions During Sedation
研究概览
简要总结
This will be a randomized trial of propofol versus the combination of propofol and ketamine for procedural sedation for procedures in the Emergency Department (ED). Propofol produces sedation, hypnosis, and dense amnesia, and is commonly used in the ED at Hennepin County Medical Center (HCMC) for procedural sedation. Ketamine is a dissociative anesthetic that is also frequently used in the ED in children and sometimes in adults. It has been proposed that by combining the two agents, the negative side effects of respiratory depression and hypotension associated with propofol, and the negative effects of dysphoria and vomiting associated with ketamine, can be avoided.
In the proposed study, patients seen in the ED who will require procedural sedation for a painful procedure will be randomized to receive either propofol or propofol and ketamine. During the procedure, patients will be monitored per the standard of care, including use of a cardiac monitor, non-invasive blood pressure monitoring, pulse oximetry, nasal sample end-tidal carbon dioxide, and physician assessment. Once the procedure is successfully completed and the patient has returned to his/her baseline mental status, the patient will be asked to mark a 100 mm visual analog scale regarding perceived pain during the procedure, memory of the procedure, and overall satisfaction with the procedure.
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
- 1 Year 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing procedural sedation for an urgent procedure in the Emergency Department
排除标准
- •Allergy to propofol or ketamine, intoxication, altered mental status, ASA physical status score >2
研究组 & 干预措施
Propofol
Deep sedation using propofol
干预措施: Propofol (Drug)
结局指标
主要结局
Clinical Interventions During Sedation
时间窗: From start of sedation procedure to end of sedation procedure, up to 24 hours
Add/increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, assisted ventilations, endotracheal intubation
Hypoxia
时间窗: From start of sedation procedure to end of sedation procedure, up to 24 hours
Pulse oximetry
次要结局
- Respiratory Depression(From start of sedation procedure to end of sedation procedure, up to 24 hours)
- Procedural Recall(Immediately after the end of the procedure, a single time point within 30 minutes of procedures conclusion.)
