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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00978978
First received: September 16, 2009
Last updated: October 11, 2009
Last verified: September 2009
  Purpose

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 Intervention
Liver Cirrhosis
Drug: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Official Title: Propofol Versus Midazolam and Fentanyl for Diagnostic and Screening Colonoscopy in Patients With Advanced Liver Disease

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

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

Estimated Enrollment: 60
Study Start Date: October 2009
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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)
  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: 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
  More Information

No publications provided

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
Study First Received: September 16, 2009
Last Updated: October 11, 2009
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Liver Diseases
Liver Cirrhosis
Digestive System Diseases
Liver Extracts
Propofol
Midazolam
Fentanyl
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
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

ClinicalTrials.gov processed this record on October 02, 2014