Performance of Endoscopic Submucosal Dissection According to the Sedation Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Satisfaction of endoscopists
研究概览
简要总结
Although proper sedation is mandatory for endoscopic procedures such as endoscopic submucosal dissection, the effects of sedation on ESD performance and complications have not been fully evaluated. In the investigators previous retrospective study, en bloc resection and complete resection rates, and procedure time could be improved by sedation with continuous propofol infusion with opioid administration by anesthesiologists. However, there are several limitations to the study including retrospective design. The investigators aimed to evaluate the relationship among sedation methods, satisfaction of endoscopists or patients, clinical outcomes, and complications after endoscopic submucosal dissection for gastric neoplasia.
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
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age, between 20 and 80
- •Early gastric cancer or adenoma, which is indicated by endoscopic submucosal dissection
- •ECOG performance status 0 or 1
- •American Society of Anesthesiologist Physical Status 1, 2, or 3
排除标准
- •Previous subtotal gastrectomy
- •Previous gastrostomy
- •Repeated endoscopic submucosal dissection
- •Three or more synchronous lesions
- •Allergy to midazolam, propofol, fentanyl, or remifentanil
- •Pregnancy or breast milk feeding
- •Active infection
- •Significant cardiopulmonary disease
- •Active hepatitis or severe hepatic dysfunction
- •Severe renal dysfunction
- •Severe bone marrow dysfunction
- •Severe neurologic or psychotic disorder
研究组 & 干预措施
midazolam/propofol injection
Intermittent midazolam/propofol injection controlled by endoscopist
干预措施: Intermittent midazolam/propofol injection controlled by endoscopist (Procedure)
propofol infusion
Continuous propofol infusion with opioid administration
干预措施: Continuous propofol infusion with opioid administration (Procedure)
结局指标
主要结局
Satisfaction of endoscopists
时间窗: Within 10 minutes from the end of the endoscopic submucosal dissection
次要结局
未报告次要终点