Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection
试验速览
- 阶段
- 3 期
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- the satisfaction of patients and endoscopist in midazolam and meperidine induced sedation with BIS monitoring during ESD
研究概览
简要总结
Background: Endoscopic submucosal dissection (ESD) usually requires adequate level of sedation due to lengthy and uncomfortable procedure. Propofol induced sedation with bispectral index (BIS) monitoring has been reported to lead to higher satisfaction of patients and endoscopists during ESD. However, there is no data about efficacy of midazolam and meperidine induced sedation with BIS monitoring during ESD. This study was to evaluate whether midazolam and meperidine induced sedation with BIS monitoring could improve the satisfaction and reduce the dose of midazolam and meperidine during ESD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gastric adenomas, differentiated-type gastric cancers greater than 30 mm in diameter without ulceration and gastric cancers up to 30 mm with ulceration, or minute submucosal invasion
排除标准
- •if they were under 18 years of age
- •had an ASA classification of 4-5
- •were pregnant
- •had a history of stroke or an allergy to sedative drugs.
结局指标
主要结局
the satisfaction of patients and endoscopist in midazolam and meperidine induced sedation with BIS monitoring during ESD
时间窗: within the one day after ESD
次要结局
- the dose of midazolam and meperidine during ESD with BIS monitoring(within one hour after ESD)