Propofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B

Ziv Hospital90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Liver Disease

Interventions

Propofol and RemifentnylDRUG

Intervention group (Propofol and remifentanyl): It will be administered under direct gastroenterologists' and hepatologist

midazolam and fentanylDRUG

Intervention group (Propofol and fentanyl ): It will be administered under direct gastroenterologists'and hepatologist

midazolam anf fentanylDRUG

group (Midazolam with Fentanyl): Both drugs will be administered by the gastroenterologists and/ or hepatologist and/ or anesthiologist

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 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

Locations (1)

Ziv medical center liver unit

Safed, Israel, Israel

Outcomes

Primary Outcomes

Safety and efficacy of propofol in liver diseases

At the end of each endoscopy

Time frame: up to 3 hours

Central Contacts

Assy Nimer, MD

CONTACT

+97246828445 ASSY.N@ZIV.HEALTH.GOV.IL

Data from ClinicalTrials.gov

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