Propofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Safety and efficacy of propofol in liver diseases
研究概览
简要总结
This is a prospective, randomized-controlled trial (RCT) comparing the use of Propofol and Remifentanyl and traditional sedation (Midazolam and Fentanyl) for diagnostic colonoscopies in patients with compensated cirrhosis child A-B. The working hypothesis is that the use of propofol will be translated in a shorter recovery and discharge times with a higher patient satisfaction and a decrease in general complications (Hepatic Encephalopathy) in the context of patients with advanced liver disease.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients older than 18 and younger than 75 years with cirrhosis defined by the presence of liver fibrosis at least F3 and higher in the METAVIR score or with established cirrhosis (Child Pugh A, B)
排除标准
- •Patients with significant cardiorespiratory disease i.e. advanced respiratory, renal and heart failure (ASA class III or higher except for patients with decompensate liver cirrhosis), obstructive sleep apnea.
研究组 & 干预措施
Propofol and Remifentanyl
Propofol, colonoscopies, liver diseases, cirrhosis
干预措施: Propofol and Remifentnyl (Drug)
midazolam and fentanyl
midazolam and fentanyl, colonoscopies, liver diseases
干预措施: midazolam and fentanyl (Drug)
control midazolam anf fentanyl
midazolam anf fentanyl
干预措施: midazolam anf fentanyl (Drug)
结局指标
主要结局
Safety and efficacy of propofol in liver diseases
时间窗: up to 3 hours
At the end of each endoscopy
次要结局
未报告次要终点