Propofol Versus Midazolam and Fentanyl for Diagnostic and Screening Colonoscopy in Patients With Advanced Liver Disease

Not Applicable

• Conditions: Liver Cirrhosis
• Interventions: Drug: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases

• Registration Number: NCT00978978
• Lead Sponsor: Soroka University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-09
• Study First Submitted: 2009-09-16
• Study First Submitted QC: 2009-09-16
• Study First Posted: 2009-09-17
• Study Start: 2009-10
• Last Update Submitted: 2009-10-11
• Last Update Posted: 2009-10-14
• Primary Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
midazolam and fentanyl, endoscopies, liver diseases	Propofol VS. midazolam and fentanyl, endoscopies, liver diseases	Control: midazolam and fentanyl, endoscopies, liver diseases
Propofol, endoscopies, liver diseases	Propofol VS. midazolam and fentanyl, endoscopies, liver diseases	Propofol, endoscopies, liver diseases

Primary Outcome Measures

Name	Time	Method
Safety and efficacy of propofol in liver diseases	At the end of each endoscopy

Trial Locations

Locations (1)

Department of Gastroenterology. Soroka University Medical Center; 🇮🇱 Beer-Sheva, Israel