Dexmedetomidine-ketamine Versus Propofol-ketamine for Sedation During Upper Gastro-intestinal Endoscopy in Hepatic Patients (a Comparative Randomized Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- induction time
研究概览
简要总结
We aim to compare the response to ketamine/dexmedetomidine and ketamine/propofol combinations used in hepatic patients with child-Pugh classification (class A), and early (class B) undergoing UGIE.
详细描述
70 Patients will be randomly allocated into two groups; Group (KD): Ketamine/dexmedetomidine (35 patients), will receive IV ketamine 0.25mg/kg and dexmedetomidine1µg/kg over 10 min as loading followed by dexmedetomidine infusion with a rate of 0.5µg/kg/hr and Group (KP): ketamine/propofol (35 patients) will receive IV ketamine 0.25 mg/kg loading and propofol 1 mg/kg over 10 min followed by propofol infusion with a rate of 0.5 mg/kg/hr as a control group.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hepatic patients with child-Pugh classification (class A), and (class B)
- •American Society of Anesthesiologists physical status II, III
- •aged 18 to 60 years
- •scheduled for elective Upper gastro-intestinal endoscopy.
排除标准
- •emergency gastro-intestinal endoscopy.
- •patients with severe hepatic disorder (Child C) ,
- •chronic neuro-psychiatric disorder,
- •history of neuro-psychiatric drug intake,
- •severe cardiovascular diseases,
- •pregnancy,
- •history of drug abuse, and
- •history of allergy to any of the used drugs in the study
研究组 & 干预措施
Group KD
participants received loading of ketamine 1 mg/kg and dexmedetomidine 1µg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr ketamine and 0.25µg/kg/hr dexmedetomidine throughout the procedure.
干预措施: Dexmedetomidine (Drug)
Group KP
participants received loading of ketamine 1 mg/kg and propofol 1 mg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr propofol and 0.25 µg/kg/hr dexmedetomidine throughout the procedure.
干预措施: Propofol (Drug)
结局指标
主要结局
induction time
时间窗: after 5 minutes from the start of drug infusion till target Ramsay Sedation Score ≥ 3 is reached
Time to reach target Ramsay Sedation Score ≥ 3
Recovery time
时间窗: after 10 minutes from the stoppage of drug infusion at the end of the procedure till spontaneous eye opening
time from the stoppage of drug infusion at the end of the procedure till spontaneous eye opening
次要结局
未报告次要终点
研究者
Tamer Nabil Abdelrahman
lecturer of anaesthesia, intensive care and pain management
Ain Shams University