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

Soroka University Medical Center60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Liver Cirrhosis

Interventions

Propofol VS. midazolam and fentanyl, endoscopies, liver diseasesDRUG

1. Intervention group (Propofol): It will be administered as a monotherapy under direct gastroenterologists' 2. Control group (Midazolam with or without Fentanyl): Both drugs will be administered by the gastroenterologists

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (1)

Department of Gastroenterology. Soroka University Medical Center

Beersheba, Beer-Sheva, Israel

Outcomes

Primary Outcomes

Safety and efficacy of propofol in liver diseases

Time frame: At the end of each endoscopy

Central Contacts

Jorge-Shmuel Delgado, MD

CONTACT

972-8-6403164 delgado@bgu.ac.il

Data from ClinicalTrials.gov

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