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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Ziv Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01148277
First received: June 13, 2010
Last updated: April 5, 2011
Last verified: June 2010
  Purpose

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 Intervention
Liver Disease
Drug: Propofol and Remifentnyl
Drug: midazolam and fentanyl
Drug: midazolam anf fentanyl

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Propofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • Safety and efficacy of propofol in liver diseases [ Time Frame: up to 3 hours ] [ Designated as safety issue: Yes ]
    At the end of each endoscopy


Estimated Enrollment: 90
Study Start Date: August 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Liver Clinic, Ziv medical center
ClinicalTrials.gov Identifier: NCT01148277     History of Changes
Other Study ID Numbers: Propofol vs Midazolam
Study First Received: June 13, 2010
Last Updated: April 5, 2011
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 24, 2014