Physiologic Stress During Procedural Sedation With and Without Alfentanil
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Serum Catecholamines
研究概览
简要总结
This is a randomized clinical trial of deep procedural sedation with propofol with and without supplemental alfentanil. Patients will be assessed for total and fractionated serum catecholamines before and after the procedure in addition to usual procedural sedation outcomes parameters to assess the adrenergic effect of propofol sedation without supplemental opioid.
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 will require deep procedural sedation with propofol in the ED
排除标准
- •intoxication
- •unable to provide informed consent
- •allergy to propofol or alfentanil
- •ASA physical status score > 2
研究组 & 干预措施
Propofol
propofol only for deep procedural sedation
干预措施: propofol (Drug)
Propofol/alfentanil
Propofol with alfentanil for deep procedural sedation
干预措施: propofol (Drug)
Propofol/alfentanil
Propofol with alfentanil for deep procedural sedation
干预措施: alfentanil (Drug)
结局指标
主要结局
Change in Serum Catecholamines
时间窗: one minute prior to the start of the procedure and immediately at the end of sedation procedure (median time of procedure 12 minutes range 6-26 minutes
change in serum catecholamine levels, values indicate a decrease over the procedure. These patients underwent fracture reduction procedures which are typically associated with an increase in catecholamines.
次要结局
- Respiratory Depression(From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status)
- Patient Reported Pain and Recall of the Painful Procedure for Which They Were Sedated Measure by Patient Query After They Had Regained Their Baseline Level of Consciousness After the Procedure(single time point measured after sedation procedure completed)