Target-controlled Infusion vs Patient-controlled Sedation With Propofol in ERCP. A Randomized Prospective Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- patient's and endoscopist´s satisfaction,
研究概览
简要总结
Propofol is a drug of choice for deep sedation in endoscopy. Propofol can be administered in many ways: by infusion or intravenous boluses and with self-administration device (patient-controlled sedation; PCS). It is not clear which method of propofol administration would be preferable. The main objective of the trial is to compare 2 different methods of propofol administration during ERCP: patient-controlled administration(PCS) and target-controlled infusion (TCI).
详细描述
80 patients of age 18-75 undergoing elective ERCP will be included to the randomized non-commercial clinical trial. Exclusion criteria are: allergy to the opioids or propofol, dementia, mental retardation, severe liver or kidney insufficiency, significant heart failure or lung disease, drug addiction. The endpoints are: ease of procedures performance, complications, degree of sedation, recovery time, propofol and opioid consumption. During the procedure patients observed and treated by the anaesthesiologist and anaesthesia nurse .
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective ERCP patients
排除标准
- •allergy to propofol or opioid;
- •inability to cooperate;
- •ASA(American Society of Anaesthesiology)class greater than 3
结局指标
主要结局
patient's and endoscopist´s satisfaction,
时间窗: One day
vital signs:oxygen saturation,blood pressure,heart rate,breathing rate
时间窗: One day
sedation degrees
时间窗: One day
propofol consumption
时间窗: One day
次要结局
未报告次要终点
研究者
Maxim Mazanikov
MD
Helsinki University Central Hospital