Safe and Effective Sedation in Chronic Alcoholic Patients Underwent Diagnostic Endoscopic Procedures: a Prospective, Randomized Study Comparing Midazolam and Propofol With Midazolam
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Satisfaction of endoscopists, nurses and patients
研究概览
简要总结
Sedative endoscopic examination using sedative premedication has been undertaken to induce conscious sedation for comfortable and painless endoscopy. Midazolam has been most widely used as a sedative premedication because it has lots of advantages, such as a short half-life, a faster onset of sedation and an excellent sedative hypnotic effect. However, midazolam has been used regardless of whether or not alcohol although using midazolam in chronic alcoholics is related to paradoxical reaction, characterized by increased talkativeness, emotional release, excitement, and excessive movement. In recent years, propofol has been used safety and effectively in sedative GI endoscopy because of its potent hypnotic effect and its ultrashort pharmacokinetic profile. Therefore, The present study was conducted to compare the safety and efficacy of BPS (propofol in combination with midazolam) with conventional sedation (midazolam) in chronic alcoholic patients undergoing diagnostic GI endoscopic procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient who consents to enroll the trial
排除标准
- •age < 20
- •pregnant or lactating women
- •American Society of Anesthesiology (ASA) physical status class V
- •chronic pulmonary disease
- •history of allergic to propofol
- •history of complication of sedation endoscope
- •liver failure or hepatic encephalopathy
- •who didn't consented to enroll the trial
研究组 & 干预措施
conventional sedation group
midazolam
干预措施: Midazolam (Drug)
BPS group
midazolam plus propofol
干预措施: Midazolam plus propofol (Drug)
结局指标
主要结局
Satisfaction of endoscopists, nurses and patients
时间窗: about 5 minutes after the end of the procedure
endoscopists and nurses - about 5 minutes after the end of the procedure / patients - upon meeting discharge criteria (modified Aldrete score), an expected average of 20min
次要结局
- completion rate of endoscopy(about 5 minutes after the end of procedure)
- number of participants with complications(participants will be followed during the procedure and recovery time, an expected average of 20 min)
