Monitored Anesthesia Care With Propofol Plus Remifentanil During Endoscopic Submucosal Dissection: Evaluation of Bispectral Index Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- procedure satisfaction score of propofol addition
研究概览
简要总结
There are clinical usefulness issues associated with bispectral index (BIS) for sedation of endoscopic submucosal dissection (ESD). However, the clinical usefulness of BIS for deep sedation is incompletely described. The purpose of this study is to show that BIS-guided sedation is safe and useful clinically and may provide stable sedation status to physicians and patients.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I to II.
排除标准
- •body mass index (BMI) over 35 (Kg/m2)
- •hepatic or renal insufficiency
- •history of allergy to the drugs used
- •history of administration of anxiolytics, narcotics, antipsychotics, opioid.
研究组 & 干预措施
BIS group
The BIS group (n=90) was monitored for sedation depth using BIS during ESD.
干预措施: BIS sensor attachment (Device)
No-BIS group
The no-BIS group (n=90) was monitored by observer's assessment alertness/sedation scale (OAA/S).
干预措施: no- BIS sensor attachment (Drug)
结局指标
主要结局
procedure satisfaction score of propofol addition
时间窗: an average time for 1 week from propofol addition
The evaluation of sedation depth using OAA/S will be performed at 1 minute after propofol administration, endoscopy insertion, submucosal inflation by 1:100000 epinephrine with indigocarmine, initial submucosal dissection and when the patient have restlessness or coughing additively.
次要结局
未报告次要终点