Comparing Efficacy of Oral Midazolam and Sublingual Alprazolam in Reducing Anxiety and Pain/Discomfort Related to Diagnostic Upper Gastrointestinal Endoscopy in Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Discomfort assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake
研究概览
简要总结
Diagnostic upper GI endoscopy can be uncomfortable and stressful for many 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. Intravenous midazolam is being used by some centers for sedation during endoscopy, but the oral form can also be used with probably same efficacy. Hence, investigators compare the efficacy/safety of oral midazolam and sublingual alprazolam as for sedation during this procedure. Investigators hypothesize that sublingual alprazolam is as effective as oral midazolam in reducing anxiety and pain/discomfort related to the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
Sublingual alprazolam
干预措施: Sublingual alprazolam (Drug)
Oral midazolam
干预措施: Oral midazolam (Drug)
结局指标
主要结局
Discomfort assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake
时间窗: 5 minutes after the procedure
Procedure related discomfort is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake.
Change in anxiety
时间窗: At baseline and at 30 minutes after medication
Procedure related anxiety is assessed by patients on a 11-point numeric rating scales at baseline and then at 30 minutes after the medication.
次要结局
- Desaturation(At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.)
- Satisfaction is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake.(5 minutes after the procedure)
- Tolerance is assessed by patients from no compliance (0) to excellent compliance (4) about 5 minutes after the procedure when patients are fully awake.(5 minutes after the procedure)
- Duration of the procedure(From endoscope insertion to endoscope removal)
- Hypotension(At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.)
- Bradycardia(At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.)
研究者
Elham Tabesh
Dr.
Isfahan University of Medical Sciences