eurologic safety of etomidate-based sedation compared with propofol-based sedation during upper GI endoscopy in patients with liver cirrhosis: A double-blind, randomized controlled trial
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0004904
- Lead Sponsor
- Hallym University Medical Center-Dongtan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 126
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Psychometric tests (Number connection test)
- Secondary Outcome Measures
Name Time Method incidence of each adverse event (hypoxemia, respiratory depression, apnea, hypotension, and arrhythmia);incidence of events that interfered with the procedure (myoclonus or a paradoxical reaction);administered dose of sedatives;changes in vital signs during sedation (heart rate, systolic blood pressure, mean blood pressure and SpO2)