Propofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B
Not Applicable
- Conditions
- Liver Disease
- Interventions
- Registration Number
- NCT01148277
- Lead Sponsor
- Ziv Hospital
- Brief Summary
This is a prospective, randomized-controlled trial (RCT) comparing the use of Propofol and Remifentanyl and traditional sedation (Midazolam and Fentanyl) for diagnostic colonoscopies in patients with compensated cirrhosis child A-B. The working hypothesis is that the use of propofol will be translated in a shorter recovery and discharge times with a higher patient satisfaction and a decrease in general complications (Hepatic Encephalopathy) in the context of patients with advanced liver disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- Consecutive patients older than 18 and younger than 75 years with cirrhosis defined by the presence of liver fibrosis at least F3 and higher in the METAVIR score or with established cirrhosis (Child Pugh A, B)
Exclusion Criteria
- Patients with significant cardiorespiratory disease i.e. advanced respiratory, renal and heart failure (ASA class III or higher except for patients with decompensate liver cirrhosis), obstructive sleep apnea.
- HCC
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propofol and Remifentanyl Propofol and Remifentnyl Propofol, colonoscopies, liver diseases, cirrhosis midazolam and fentanyl midazolam and fentanyl midazolam and fentanyl, colonoscopies, liver diseases control midazolam anf fentanyl midazolam anf fentanyl midazolam anf fentanyl
- Primary Outcome Measures
Name Time Method Safety and efficacy of propofol in liver diseases up to 3 hours At the end of each endoscopy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ziv medical center liver unit
🇮🇱Safed, Israel, Israel