Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial - Tabular View

Tracking Information
First Received Date ^ICMJE	January 8, 2008
Last Updated Date	January 16, 2008
Start Date ^ICMJE	May 2003
Primary Completion Date	October 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 16, 2008)	Patient tolerance to the procedure [ Time Frame: 1 hour after the procedure ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00596414 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial
Official Title ^ICMJE	Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial
Brief 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.
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.
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study
Condition ^ICMJE	Cirrhosis Chronic Hepatitis Anxiety
Intervention ^ICMJE	Procedure: transjugular liver biopsy Drug: placebo Drug: midazolam Drug: midazolam + pethidine
Study Arms / Comparison Groups	Experimental: midazolam Experimental: midazolam + pethidine
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	180
Completion Date	October 2005
Primary Completion Date	October 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: suspected liver disease known liver disease Exclusion Criteria: liver transplants hepatocellular carcinoma hypersensitivity or allergy to benzodiazepines or morphinic derivatives
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium

Administrative Information
NCT ID ^ICMJE	NCT00596414
Responsible Party	Olivier Le Moine, MD, PhD, Erasme University Hospital
Study ID Numbers ^ICMJE	BHTJ-1, BHTJ-1
Study Sponsor ^ICMJE	Erasme University Hospital
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Erasme University Hospital
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP