A Comparison of Efficacy and Safety During Endoscopic Submucosal Dissection Between Dexmedetomidine-remifentanil and Propofol-remifentanil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- A comparison of safety during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
研究概览
简要总结
Adequate, safe sedation is essential for Endoscopic submucosal dissection. Dexmedetomidine is a potent and selective a2-adrenoceptor agonist used for sedative and analgesic effects, but it is limited to use alone. The investigators designed this study to compare the effect and safety of two sedatives, dexmedetomidine and propofol in Endoscopic Submucosal Dissection (ESD), when sufficient analgesia-remifentanil is administered all throughout the procedure.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anaesthesiologists(ASA) physical status classification I~III
- •Early gastric cancer patients who were scheduled for Endoscopic submucosal dissection
排除标准
- •Age < 20
- •American Society of Anaesthesiologists(ASA) physical status classification IV
- •those with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
- •known drug allergies or history of drug abuse
- •psychological disease
研究组 & 干预措施
DR group
In Group DR, a bolus dose of 0.5mcg/kg dexmedetomidine was injected intravenously 5 minutes before the start of the procedure (Precedex®, Abbott, Istanbul, Turkey). And a continuous infusion dose of 0.3-0.7mcg/hr/kg was started.
干预措施: Dexmedetomidine - remifentanil group (Drug)
PR group
In Group PR, a bolus injection of 1 mg/kg of propofol was followed by a continuous infusion at a rate of 3-5mg/hr/kg(Pofol®, Dongkook Pharm. Co. Ltd., Seoul, Korea) using an infusion pump (Syringe Pump TE-331, Terumo Japan).
干预措施: Propofol - remifentanil group (Drug)
结局指标
主要结局
A comparison of safety during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
时间窗: right after the drugs had administered
Safety : whether the complications as follows occur or not 1. systolic blood pressure under 90mmHg or 20% out of range of the baseline SBP 2. heart rate under 50bpm 3. oxygen saturation under 90%, respiratory rate under 7 per minute
次要结局
- A comparison of efficacy during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil(right after the drugs had administered)