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

Ziv Hospital1 site in 1 country90 target enrollmentAugust 2011

ConditionsLiver Disease

InterventionsPropofol and Remifentnyl midazolam and fentanyl midazolam anf fentanyl

DrugsPropofol and Remifentnyl midazolam and fentanyl midazolam anf fentanyl

Overview

Phase: Not Applicable
Intervention: Propofol and Remifentnyl
Conditions: Liver Disease
Sponsor: Ziv Hospital
Enrollment: 90
Locations: 1
Primary Endpoint: Safety and efficacy of propofol in liver diseases
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

February 2012

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ziv Hospital

Eligibility Criteria

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.