A Randomized, Double-Blinded, Placebo-Controlled Trial of Promethazine and Diphenhydramine as Adjunct Sedatives for Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Average Percentage of Sedation Failures
研究概览
简要总结
The purpose of this study is to compare meperidine/midazolam with diphenhydramine, meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine and promethazine) will improve sedation.
详细描述
Comparing sedation techniques during invasive endoscopic procedures such as ERCP and EUS is a relatively unexplored area of clinical research. In particular, the effectiveness of adjunct sedatives such as diphenhydramine and promethazine during ERCP/EUS procedures has not been studied. Achieving a moderate sedation level may be ideal for ERCP/EUS procedures in order to provide adequate patient comfort, amnesia, and completion of intended endoscopic procedures. The relevance of further studies in this area is apparent. In terms of clinical practice; over-sedation can lead to decreased airway protection, longer post-procedural recovery times, and unnecessary drug cost; under-sedation can lead to patient anxiety, agitation, recall, and longer procedural time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing participants between 18 and 75 years of age who present for ERCP or EUS at H.H. Comprehensive Chao Digestive Disease Center.
排除标准
- •History of allergic or adverse reactions to midazolam, diphenhydramine, or promethazine.
- •Acute asthma, narrow angle glaucoma, concurrent use of potent inhibitors of CYP3A4 (amprenavir, atazanavir, or ritonavir), pregnancy, or the inability to consent.
- •Patients with conditions that preclude safe conscious sedation will be excluded.
研究组 & 干预措施
Meperidine and midazolam group
Control. Normal Saline Injections.
干预措施: Meperidine, Midazolam (Drug)
Meperidine and midazolam, plus Diphenhydramine group
Diphenhydramine injections given as adjunct sedative.
干预措施: Meperidine, Midazolam (Drug)
Meperidine and midazolam, plus Diphenhydramine group
Diphenhydramine injections given as adjunct sedative.
干预措施: Diphenhydramine (Drug)
Meperidine and midazolam, plus Promethazne group
Promethazine given as an adjunct sedative.
干预措施: Meperidine, Midazolam (Drug)
Meperidine and midazolam, plus Promethazne group
Promethazine given as an adjunct sedative.
干预措施: Promethazine (Drug)
结局指标
主要结局
Average Percentage of Sedation Failures
时间窗: From onset of sedation to completion of procedure, approximately 1 hour.
The percentage of participants who could not complete the procedure due inability to achieve proper sedation level
Time to Achieve Adequate Level of Sedation to Begin Procedure
时间窗: Pre-Endoscopic Procedure (up to 1 hour maximum)
Time for Recovery
时间窗: Post-Endoscopic Procedure
次要结局
- Adverse Symptoms From Sedative Agents(Approximately 3 hours.)
研究者
Kenneth J. Chang
Principal Investigator
University of California, Irvine
