Propofol Versus Midazolam and Fentanyl for Diagnostic and Screening Colonoscopy in Patients With Advanced Liver Disease
Overview
- Phase
- Not Applicable
- Intervention
- Propofol VS. midazolam and fentanyl, endoscopies, liver diseases
- Conditions
- Liver Cirrhosis
- Sponsor
- Soroka University Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Safety and efficacy of propofol in liver diseases
- Last Updated
- 16 years ago
Overview
Brief Summary
Prospective, randomized-controlled trial (RCT) comparing the use of Propofol and traditional sedation (Midazolam and Fentanyl) for diagnostic and screening endoscopies in patients with liver diseases. The investigators' 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 in the context of patients with advanced liver disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Consecutive patients older than 18 and younger than 75 years with advanced liver disease, defined by the presence of liver fibrosis at least F3 and higher in the METAVIR score or with established cirrhosis (Child Pugh A, B and C)
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 or those with mild degree of liver fibrosis (less than F3)
Arms & Interventions
Propofol, endoscopies, liver diseases
Propofol, endoscopies, liver diseases
Intervention: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases
midazolam and fentanyl, endoscopies, liver diseases
Control: midazolam and fentanyl, endoscopies, liver diseases
Intervention: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases
Outcomes
Primary Outcomes
Safety and efficacy of propofol in liver diseases
Time Frame: At the end of each endoscopy