Propofol Versus Midazolam and Fentanyl for Diagnostic and Screening Colonoscopy in Patients With Advanced Liver Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 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
Prospective, randomized-controlled trial (RCT) comparing the use of Propofol and traditional sedation (Midazolam and Fentanyl) for diagnostic and screening endoscopies in patients with liver diseases. The investigators' 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 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
- 盲法
- Double (Care Provider, Investigator)
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 advanced liver disease, defined by the presence of liver fibrosis at least F3 and higher in the METAVIR score or with established cirrhosis (Child Pugh A, B and C)
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 or those with mild degree of liver fibrosis (less than F3)
研究组 & 干预措施
Propofol, endoscopies, liver diseases
Propofol, endoscopies, liver diseases
干预措施: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases (Drug)
midazolam and fentanyl, endoscopies, liver diseases
Control: midazolam and fentanyl, endoscopies, liver diseases
干预措施: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases (Drug)
结局指标
主要结局
Safety and efficacy of propofol in liver diseases
时间窗: At the end of each endoscopy
次要结局
未报告次要终点