Propofol and Fentanyl Versus Midazolam and Fentanyl for Sedation During Diagnostic or Therapeutic Gastrointestinal Endoscopy in Cirrhotic Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency
研究概览
简要总结
The purpose of this study is to compare propofol associated with fentanyl versus midazolam plus fentanyl for sedation during diagnosis or therapeutic upper gastrointestinal endoscopy (UGE) in cirrhotic patients.
详细描述
UGE is often performed in cirrhotic patients for the diagnosis and treatment of portal hypertension complications. Current data suggests that propofol sedation may have advantages over benzodiazepines. However, there are few reports comparing propofol versus midazolam in patients with liver cirrhosis. The study's objective is to compare propofol associated with fentanyl versus midazolam plus fentanyl for sedation during diagnosis or therapeutic UGE in cirrhotic patients. A prospective randomized study will include cirrhotic patients (Child A, B or C and ASA 2 or 3), referred for diagnostic or therapeutic UGE, randomized for group I: propofol (0,5 mg/kg up to 400 mg) and fentanyl (0,05 mg); or group II: midazolam (0,1 mg/kg) and fentanyl. Sedation was performed by an exclusively dedicated gastroenterologist. Efficacy (completion of procedures), complications (hypoxemia, hypotension, arrhythmias) and recovery time (elapsed from the end of the procedure and discharge) will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Liver cirrhosis, any etiology
- •ASA II or III
- •Child A, B or C
- •Age between 18 years and 75 years
- •Patients that agree in participate of study and signed the contentment term
排除标准
- •Schistosomiasis
- •Hepatocellular carcinoma
- •Contraindications to drugs
- •ASA IV or V
- •Hepatic encephalopathy, neurologic diseases
- •Opioids, narcotics, MAO inhibitors or benzodiazepines use
- •Alcohol abuse
研究组 & 干预措施
Propofol
To receive propofol (0.5 mg/kg up to 400 mg) and fentanyl (0.05 mg);
干预措施: Propofol (Drug)
Propofol
To receive propofol (0.5 mg/kg up to 400 mg) and fentanyl (0.05 mg);
干预措施: Fentanyl (Drug)
Midazolam
To receive midazolam (0.1 mg/kg) and fentanyl (0.05 mg).
干预措施: Midazolam (Drug)
Midazolam
To receive midazolam (0.1 mg/kg) and fentanyl (0.05 mg).
干预措施: Fentanyl (Drug)
结局指标
主要结局
To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency
时间窗: Three months
次要结局
未报告次要终点