Status:
UNKNOWN
Propofol Versus Midazolam and Fentanyl for Diagnostic and Screening Colonoscopy in Patients With Advanced Liver Disease
Lead Sponsor:
Soroka University Medical Center
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18-75 years
Phase:
NA
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....
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00978978
Start Date
October 1 2009
Last Update
October 14 2009
Active Locations (1)
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1
Department of Gastroenterology. Soroka University Medical Center
Beersheba, Beer-Sheva, Israel, 84101