Phase 1 Study of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Pancreatic perfusion measured by computerized tomography
研究概览
简要总结
The aim of the study is to evaluate the safety, the potential beneficial effect of epidural anesthesia on pancreatic perfusion and clinical outcome of patients with severe acute pancreatitis.
详细描述
High mortality in severe acute pancreatitis (AP) is linked to necrosis of the gland. Animal studies showed that epidural anesthesia (EA) restores pancreatic microcirculation and decreases the severity of AP. The aim of the study is to evaluate the safety of EA, its effect on pancreatic perfusion and clinical outcome of patients with AP.
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
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute pancreatitis with Ranson Criteria over 2, and/or CRP over 100, and or pancreatic necrosis on CT scan
排除标准
- •Coagulation disorders
- •Skin infection of the vertebral region
研究组 & 干预措施
Patient controlled intravenous analgesia
Fentanyl (10 microg/ml) continuous intravenous infusion at a rate of 10 to 20 microg/h
干预措施: Patient controlled intravenous analgesia (Drug)
Epidural anesthesia
Carbostesin (0.1%) and Fentanyl (2 microg/ml) at a continuous flow of 6 to 15 ml/hour
干预措施: Epidural anesthesia (Procedure)
结局指标
主要结局
Pancreatic perfusion measured by computerized tomography
时间窗: On day 0 and day 2 or 3 after hospital admission
Number of patients with adverse events related to epidural anesthesia
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks
Adverse events related to epidural anesthesia include hypotensive episodes or infection of the catheter
次要结局
- Clinical outcome(Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks)
研究者
Leo Buhler
Associate Professor
University Hospital, Geneva