Effect of Midazolam Premedication on the Satisfaction Levels of Patients After Endoscopic Submucosal Dissection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Willingness to receive same method of sedation for ESD in the future as yes or no
研究概览
简要总结
Endoscopic submucosal dissection is commonly performed under light to moderate sedation, and minimizing patient movement is of key importance for successful outcome. Propofol has widely replaced benzodiazepines as sedative drug of choice, and has been reported to enhance the quality of procedure in our past study. However, despite higher satisfaction scores of the endoscopists and faster post-procedural recovery, patient satisfaction scores were found to be higher in patients that received midazolam and meperidine instead of propofol and remifentanil. This seems to be due to the anterograde amnestic effects of midazolam rather than the quality of sedation itself. Investigator hypothesized that by premedicating the patient with low lose midazolam before receiving sedation for ESD with propofol and fentanyl, patient satisfaction would be enhanced without affecting endoscopic performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients over the age of 19 diagnosed with early gastric cancer or gastric adenoma that are scheduled for endoscopic submucosal dissection
- •American society of anesthesiologist physical status 1~3
排除标准
- •Patient refusal
- •Patients that received sedatives within 24 hours prior to endoscopic submucosal dissection
- •History of gastrectomy or previous endoscopic submucosal dissection at same site
- •Allergies to propofol or its ingredients, soybeans or peanuts
- •Pregnant or breastfeeding patients
- •Patients with severe debilitating underlying medical conditions
- •Patients with altered mental status
- •Illiterate patients or foreigners
研究组 & 干预措施
No premedication
No premedication before sedation
干预措施: No premedication (Drug)
Midazolam
Premedication with midazolam before sedation
干预措施: midazolam 0.02mg/kg (Drug)
结局指标
主要结局
Willingness to receive same method of sedation for ESD in the future as yes or no
时间窗: 24 hours after ESD
Any recall of the ESD procedure on a scale from 0 to 2 (0; no recall, 1; partial recall, 2; can recall most of procedure)
时间窗: 24 hours after ESD
Post-procedural pain on a VAS scale of 0 to 10
时间窗: at 1 hour and 24 hours after ESD
Overall patient satisfaction scores on a scale from 0 to 10
时间窗: 24 hours after ESD
次要结局
未报告次要终点