Clinical safety and efficacy of etomidate-based sedation compared with propofol-based sedation during upper GI endoscopy in patients with liver cirrhosis: A double-blind, randomized controlled trial
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 126
研究概览
简要总结
Sixty-three patients were enrolled in each of the etomidate and propofol groups. NCT times were significantly lower in the etomidate than the propofol group (54.1 [43.8] vs 85.1 [111.9] seconds, P=0.044). Furthermore, severe or very severe encephalopathy, as indicated by NCT results, was higher in the propofol group, although not significantly so. Other pharmacological properties did not differ significantly between etomidate and propofol groups, including induction time (110.2 [94.0] vs 122.5 [65.0] seconds, P=0.392), awake time (12.4 [7.8] vs 10.7 [6.4] minutes, P=0.181), and recovery time (22.9 [8.9] vs 20.4 [8.2] minutes, P=0.114). Additionally, the overall incidence of respiratory and cardiovascular events did not differ significantly between the groups.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •For patients with cirrhosis who meet clinical, biochemical and histological criteria from 18 to 80 years of age who need diagnostic or therapeutic upper gastrointestinal endoscopy.
排除标准
- •1. Clinically confirmed or suspected hepatic coma or subjects with neurological / psychiatric disorders or problems
- •2. Subjects who have recently taken neuro / psychiatric drugs or who have taken drugs related to metabolism of propofol or etomidate
- •3. Persons with a past history of risk cases among past sedation endoscopy
- •4. Subjects who are sensitive to etomidate, propofol or fentanyl, or those who are sensitive to eggs, beans, etc.
- •5. Subjects with adrenal hypogonadism, chronic steroid therapy, or subjects with porphyria
- •6. Subjects with severe renal disease (serum creatinine more than 2mg / dL)
- •7. Pregnant women or those who are breastfeeding
- •8. Subjects who wish to receive an endoscope without compromising
- •9. Subject who has not obtained informed consent
- •10. Subject who has less than 90% oxygen saturation in the absence of oxygen, or less than 95% oxygen saturation despite supply of 2 L / min.
- •11. Subjects with basal systolic blood pressure less than 90 mmHg or diastolic blood pressure less than 50 mmHg or subjects with mean blood pressure less than 60 mmHg