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Propofol Versus Midazolam and Fentanyl for Diagnostic and Screening Colonoscopy in Patients With Advanced Liver Disease

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ClinicalTrials.gov Identifier: NCT00978978
Recruitment Status : Unknown
Verified September 2009 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 17, 2009
Last Update Posted : October 14, 2009
Sponsor:
Information provided by:
Soroka University Medical Center

Brief Summary:
Prospective, randomized-controlled trial (RCT) comparing the use of Propofol and traditional sedation (Midazolam and Fentanyl) for diagnostic and screening endoscopies in patients with liver diseases. The investigators' 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 in the context of patients with advanced liver disease.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Drug: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Official Title: Propofol Versus Midazolam and Fentanyl for Diagnostic and Screening Colonoscopy in Patients With Advanced Liver Disease
Study Start Date : October 2009
Estimated Primary Completion Date : August 2010


Arm Intervention/treatment
Active Comparator: Propofol, endoscopies, liver diseases
Propofol, endoscopies, liver diseases
Drug: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases
  1. Intervention group (Propofol): It will be administered as a monotherapy under direct gastroenterologists'
  2. Control group (Midazolam with or without Fentanyl): Both drugs will be administered by the gastroenterologists
Active Comparator: midazolam and fentanyl, endoscopies, liver diseases
Control: midazolam and fentanyl, endoscopies, liver diseases
Drug: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases
  1. Intervention group (Propofol): It will be administered as a monotherapy under direct gastroenterologists'
  2. Control group (Midazolam with or without Fentanyl): Both drugs will be administered by the gastroenterologists



Primary Outcome Measures :
  1. Safety and efficacy of propofol in liver diseases [ Time Frame: 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 advanced liver disease, defined by the presence of liver fibrosis at least F3 and higher in the METAVIR score or with established cirrhosis (Child Pugh A, B and C)

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 or those with mild degree of liver fibrosis (less than F3)

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): NCT00978978


Contacts
Contact: Jorge-Shmuel Delgado, MD 972-8-6403164 delgado@bgu.ac.il

Locations
Israel
Department of Gastroenterology. Soroka University Medical Center Not yet recruiting
Beer-Sheva, Israel, 84101
Contact: Jorge-Shmuel Delgado, MD       delgado@bgu.ac.il   
Principal Investigator: Jorge-Shmuel Delgado, MD         
Sponsors and Collaborators
Soroka University Medical Center

Responsible Party: Jorge-Shmuel Delgado, MD., Department of Gastroenterology & Hepatology. Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00978978     History of Changes
Other Study ID Numbers: SOR484909CTIL
First Posted: September 17, 2009    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Liver Diseases
Liver Cirrhosis
Digestive System Diseases
Liver Extracts
Propofol
Midazolam
Fentanyl
Hematinics
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