Randomised Controlled Study Comparing Use of Popofol Plus Fentanyl Versus Midazolam Plus Fentanyl as Sedation in Diagnostic Endoscopy in Patients With Advanced Liver Disease.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Level of sedation
研究概览
简要总结
Gastrointestinal endoscopy is a frequent procedure in the patients with advanced liver disease. It requires variable degree of sedation ranging from minimal sedation to general anesthesia aiming for relieving pain, anxiety, and bad memories of the procedure.
In conscious sedation, patients are able to make purposeful responses to auditory and tactile clues, with maintenance of ventilatory and circulatory stability. while, in deep sedation, patients respond only to painful stimuli, and airway support is frequently required. At the level of general anesthesia, patients are unresponsive, and airway support is mandatory.
详细描述
The aim of this study is to compare use of propofol or midazolam as sedative for patients with advanced liver disease presented for gastrointestinal endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 40 and 60 years old.
- •With Child score B or C
- •Presented for elective gastrointestinal endoscopy
排除标准
- •Emergent condition like hematemesis.
- •Patients with moderate to severe hepatic encephalopathy.
- •Patients with hepatopulmonary syndrome.
- •Patients with known or suspected hypersensitivity to the used medication were also excluded from the study.
研究组 & 干预措施
M group
Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg
干预措施: Fentanyl (Drug)
M group
Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg
干预措施: Midazolam (Drug)
P Group
Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v
干预措施: Propofol (Drug)
P Group
Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v
干预措施: Fentanyl (Drug)
结局指标
主要结局
Level of sedation
时间窗: 6 months
Level of sedation using Ramsay sedation agitation score at before induction of sedation
次要结局
未报告次要终点
研究者
Sherief Abd-Elsalam
Consultant
Tanta University