Patient-controlled Sedation vs Propofol Infusion for ERCP:a Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- vital signs
研究概览
简要总结
Background: Deep sedation with propofol and opioid is commonly used for endoscopic retrograde cholangiopancreatography (ERCP), but is associated with increased morbidity and mortality. Delivery of propofol and short-acting potent opioid analgesic using a self-administration device (patient-controlled sedation, PCS) could be another option for this purpose. Comparative studies with PCS for ERCP are lacking.The main objective of this prospective randomized trial trial was to compare PCS with propofol/remifentanil to anaesthesiologist managed propofol sedation during ERCP.
详细描述
80 elective ERCP patients were randomized to anaesthesiologist managed propofol sedation (PI-group) or PCS with propofol/remifentanil (PCS-group). Sedation degree was estimated every 5 min throughout the procedure using Ramsay´s and Gillham´s sedation scores. Total amount of propofol was calculated at the end of procedure. Endoscopists´ and patients´ satisfaction was evaluated with questionary.
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 70 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;
- •ASA-class (American Society of Anaesthesiology) greater than 3;
- •inability to co-operate;
- •drugs abuse.
研究组 & 干预措施
Propofol infusion
Anaesthesiologist's managed intravenous infusion of propofol 10mg/ml
干预措施: infusion pump (Device)
Propofol infusion
Anaesthesiologist's managed intravenous infusion of propofol 10mg/ml
干预措施: propofol (Drug)
Propofol infusion
Anaesthesiologist's managed intravenous infusion of propofol 10mg/ml
干预措施: fentanyl (Drug)
Patient-controlled sedation
self-administration of propofol and remifentanil mixture during ERCP
干预措施: infusion pump for patient-controlled sedation (Device)
Patient-controlled sedation
self-administration of propofol and remifentanil mixture during ERCP
干预措施: propofol (Drug)
Patient-controlled sedation
self-administration of propofol and remifentanil mixture during ERCP
干预措施: sedative mixture (Drug)
Patient-controlled sedation
self-administration of propofol and remifentanil mixture during ERCP
干预措施: remifentanil hydrochlorid (Drug)
结局指标
主要结局
vital signs
时间窗: one day
heart rate,blood pressure,peripheral oxygen saturatuion,breathing rate,expiratory carbon dioxide concentration
patient´s and endoscopist´s satisfaction
时间窗: one day
Likert scale 1-7
propofol and opioid consumption
时间窗: one day
total consumption of propofol,milligramms and opioid,microgramms during ERCP procedure
次要结局
- sedation level(one day)
研究者
Maxim Mazanikov
M.D.
Helsinki University Central Hospital