Status:
COMPLETED
Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients
Lead Sponsor:
Ziv Hospital
Conditions:
Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Upper GI endoscopy is often performed in patients with chronic liver disease to screen for esophageal and gastric varices. The purpose of this study is to compare propofol to midazolam for sedation in...
Detailed Description
Background : Upper GI endoscopy is often performed in patients with chronic liver disease to screen for esophageal and gastric varices. AIM: The purpose of this study is to compare propofol to midazol...
Eligibility Criteria
Inclusion
- Known chronic liver disease (Child-Pugh class A or B) who presented for upper GI endoscopy for routine variceal screening.
- The diagnosis of liver disease will be based on available past history, serological testing, radiological imaging, and liver histology when available.
- Staging of cirrhosis will be determined by MELD score and by Child-Pugh score . All patients will complete a standard preprocedure history and physical examination to establish current degree of encephalopathy and ascites.
Exclusion
- Exclusion criteria will include the following:
- known allergy or adverse reaction to sedative or component thereof
- patients with known significant respiratory disease or airway abnormality)
- active neurological impairment including clinically detectable hepatic encephalopathy
- advanced or decompensated liver disease ( CP score \>10, MELD \>24) (Child-Pugh class C)
- active alcohol consumption or illicit drug abuse
- active prescription for sedation or narcotics
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01141036
Start Date
July 1 2008
End Date
February 1 2009
Last Update
June 10 2010
Active Locations (1)
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1
Ziv medical center liver unit
Safed, Israel, Israel, 13100