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

April 5, 2011 updated by: Ziv Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Safed, Israel, Israel, 13100
        • Ziv medical center liver unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Propofol and Remifentanyl
Propofol, colonoscopies, liver diseases, cirrhosis
Drug: Propofol and Remifentnyl
Intervention group (Propofol and remifentanyl): It will be administered under direct gastroenterologists' and hepatologist
ACTIVE_COMPARATOR: midazolam and fentanyl
midazolam and fentanyl, colonoscopies, liver diseases
Drug: midazolam and fentanyl
Intervention group (Propofol and fentanyl ): It will be administered under direct gastroenterologists'and hepatologist
EXPERIMENTAL: control midazolam anf fentanyl
midazolam anf fentanyl
Drug: midazolam anf fentanyl
group (Midazolam with Fentanyl): Both drugs will be administered by the gastroenterologists and/ or hepatologist and/ or anesthiologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and efficacy of propofol in liver diseases
Time Frame: up to 3 hours
At the end of each endoscopy
up to 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziv Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ANTICIPATED)

February 1, 2012

Study Completion (ANTICIPATED)

February 1, 2012

Study Registration Dates

First Submitted

June 13, 2010

First Submitted That Met QC Criteria

June 20, 2010

First Posted (ESTIMATE)

June 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 6, 2011

Last Update Submitted That Met QC Criteria

April 5, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Propofol vs Midazolam

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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