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

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ClinicalTrials.gov Identifier: NCT01148277
Recruitment Status : Unknown
Verified June 2010 by Ziv Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 22, 2010
Last Update Posted : April 6, 2011
Sponsor:
Information provided by:
Ziv Hospital

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.

Condition or disease Intervention/treatment Phase
Liver Disease Drug: Propofol and Remifentnyl Drug: midazolam and fentanyl Drug: midazolam anf fentanyl Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Propofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B
Study Start Date : August 2011
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : February 2012


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



Primary Outcome Measures :
  1. Safety and efficacy of propofol in liver diseases [ Time Frame: up to 3 hours ]
    At the end of each endoscopy



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • HCC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148277


Contacts
Contact: Assy Nimer, MD +97246828445 ASSY.N@ZIV.HEALTH.GOV.IL

Locations
Israel
Ziv medical center liver unit Not yet recruiting
Safed, Israel, Israel, 13100
Contact: Nimer Assy, MD    +972-46828445    assy.n@ziv.health.gov.il   
Sponsors and Collaborators
Ziv Hospital

Responsible Party: Liver Clinic, Ziv medical center
ClinicalTrials.gov Identifier: NCT01148277     History of Changes
Other Study ID Numbers: Propofol vs Midazolam
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: April 6, 2011
Last Verified: June 2010

Keywords provided by Ziv Hospital:
Endoscopies
Liver diseases
Propofol
Midazolam and remifentanyl

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Propofol
Midazolam
Remifentanil
Fentanyl
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action