Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial
Information source: Erasme University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cirrhosis; Chronic Hepatitis; Anxiety
Intervention: transjugular liver biopsy (Procedure); placebo (Drug); midazolam (Drug); midazolam + pethidine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Erasme University Hospital
Summary
Transjugular liver catheterisation allows the measurement of hepatic venous pressure gradient
(HVPG) and the sampling of liver tissue but patient's tolerance to the procedure is unknown.
The aim of this study was to assess tolerance to transjugular hepatic liver biopsy with or
without conscious sedation/analgesia.
Clinical Details
Official title: Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study
Primary outcome: Patient tolerance to the procedure
Detailed description:
Consecutive patients undergoing transjugular liver biopsy will be randomly assigned to
receive either placebo or midazolam (0. 02 mg/kg) or 0. 02 mg/kg midazolam combined with 1
mg/kg pethidine before the procedure.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- suspected liver disease
- known liver disease
Exclusion Criteria:
- liver transplants
- hepatocellular carcinoma
- hypersensitivity or allergy to benzodiazepines or morphinic derivatives
Locations and Contacts
Hopital Erasme - Dpt of Gastroenterology, BRUSSELS 1070, Belgium
Additional Information
Starting date: May 2003
Ending date: October 2005
Last updated: January 16, 2008
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