Effectiveness of Oral Midazolam for Sedation in Patients Undergoing Upper Gastrointestinal Endoscopy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Difference of Anxiety score
研究概览
简要总结
Can oral midazolam used for sedation in patients undergoing upper gastrointestinal endoscopy ?
详细描述
Five mg of midazolam was intake orally about 30 minutes before undergoing perform upper gastrointestinal endoscopy. Declined of anxiety scores was primary end point.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo elective diagnostic EGD
- •American Society of Anesthesia (ASA) criteria to be class 1 to 2
排除标准
- •History of gastrectomy, esophagectomy, pancreaticoduodenectomy, or other operation on the upper-GI tract
- •American Society of Anesthesia (ASA) criteria to be class 3 to 4
- •Pregnancy
- •Alcoholism
- •Drug abuse
- •Taking psychotic medications
- •Allergy to midazolam.
研究组 & 干预措施
Oral midazolam
Oral midazolam (5 mg) in 15 mL of apple juice was drunk 30 minutes before EGD
干预措施: Oral midazolam (Drug)
结局指标
主要结局
Difference of Anxiety score
时间窗: Asked the patient 5 minutes before EGD and then after fully recovery from sedation.
* Anxiety score is 10-cm scaled visual analog scale. * Anxiety score which asked the patient 5 minutes before EGD, called "Pre EGD anxiety score" * Anxiety score which asked the patient after fully recovery, called "During EGD anxiety score". * Difference of anxiety score means "Pre EGD minus During anxiety score". * Fully recovery means fully gain of consiouness (time, place, person).
次要结局
- Overall tolerance(Asked the patient after fully recovery from sedation.)