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NCT00978978 Clinical Trial

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

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00978978
Other study ID # SOR484909CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 16, 2009
Last updated October 11, 2009
Start date October 2009

Study information
Verified date September 2009
Source Soroka University Medical Center
Contact Jorge-Shmuel Delgado, MD
Phone 972-8-6403164
Email delgado@bgu.ac.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator)

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Department of Gastroenterology. Soroka University Medical Center Beer-Sheva

Sponsors (1)
Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and efficacy of propofol in liver diseases At the end of each endoscopy Yes
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