Comparison Between Sublingual and Oral Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Procedure related pain/discomfort
研究概览
简要总结
Diagnostic esophagogastroduodenoscopy is an uncomfortable and stressful procedure for most of the patients. Various methods are available for sedation during this procedure. Because of some side effects related to intravenous administration of sedatives, oral administration of these drugs is under attention. Alprazolam is a benzodiazepine which is used mainly in treatment of anxiety. Hence, we determine the efficacy of oral and sublingual alprazolam as for sedation during this procedure. We hypothesize that sublingual alprazolam is more effective than that oral form and both forms more effective than placebo in reducing anxiety and pain/discomfort related to 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
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referring for upper GI endoscopy
- •Age 18 to 65 years
- •First experience of upper GI endoscopy
- •Class I or II of American Anesthesiology Association
- •Willingness to participate
排除标准
- •Severe psychiatric, neurological, cardio-vascular, or renal disorders
- •History of allergy or intolerance to benzodiazepines or lidocaine
- •History of upper GI surgery
- •Pregnancy or lactation
- •GI anomalia during endoscopy
- •Need for therapeutic procedures during endoscopy
- •Active bleeding
研究组 & 干预措施
Oral placebo
Patients receive one oral dose of placebo least 30 minutes before the procedure.
干预措施: Oral placebo (Drug)
Sublingual placebo
Patients receive one oral dose of placebo at least 30 minutes before the procedure.
干预措施: Sublingual placebo (Drug)
Sublingual alprazolam
Patients receive one oral dose of alprazolam 0.5 mg at least 30 minutes before the procedure.
干预措施: Sublingual alprazolam (Drug)
Oral alprazolam
Patients receive one oral dose of alprazolam 0.5 mg at least 30 minutes before the procedure.
干预措施: Oral alprazolam (Drug)
结局指标
主要结局
Procedure related pain/discomfort
时间窗: Within the first one hour after the procedure
Procedure related pain/discomfort is assessed by patients on a 11-point numeric rating scales after the procedure.
次要结局
- Duration of the procedure(Within the first one hour after the procedure)
- Pre-procedure anxiety(Before and 30 minutes after medication)
- Patients' satisfaction(Within the first one hour after the procedure)
- Compliance(Within the first one hour after the procedure)
- Side effects(Within the first one hour after the procedure)
研究者
Ali Gholamrezaei
Dr.
Isfahan University of Medical Sciences