Patient-controlled Propofol Sedation for Endoscopic Retrograde Cholangiopancreatography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 281
- 试验地点
- 1
- 主要终点
- treatability
研究概览
简要总结
Propofol sedation with opioids is used for endoscopic retrograde cholangiopancreatography (ERCP). Combination of sedatives and opioids is associated with increased morbidity/mortality. Delivery of only propofol using a patient-controlled delivery system (patient-controlled sedation, PCS) could be an alternative for this purpose. Comparative studies with PCS for ERCP are few. Therefore, the main objective of this randomized controlled trial was to compare propofol PCS to sedation managed by nurse anaesthetists during ERCP.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Need for ERCP
- •Able to speak and read swedish
排除标准
- •Allergy to propofol
- •Severe cardiopulmonary disease (ASA IV)
- •Confusion or dementia
研究组 & 干预措施
Propofol sedation by nurse anaesthetist
Nurse anaesthetists managed infusion of propofol 10 mg/ml at doses of 0.2 - 0.8 ml/kg during ERCP. The target of moderate sedation was achieved within 5 minutes from start of the sedation.
干预措施: Propofol sedation by nurse anaesthestist (Drug)
Patient-controlled propofol sedation
Self-administration of propofol via patient-controlled sedation pump (CME...). No programmed lock-out period, no dose limit or background infusion. 5 mg propofol/effectuated demand from the patients. Capacity of the pump was 6 possible doses per minute.
Before start of ERCP the patients were allowed to sedate themselves to a sense of heavy tiredness.
干预措施: Patient-controlled propofol sedation (Drug)
结局指标
主要结局
treatability
时间窗: one day (per-procedural)
Registration of number of failures (where procedure is interrupted as a result of inadequate sedation). Comparison data between propofol PCS and nurse anaesthetists sedation using propofol and control group (midazolam).
次要结局
- Vital signs(one and a half year)
研究者
Lena Nilsson
MD, PhP, senior consultant
University Hospital, Linkoeping