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

This study has been completed.
Sponsor:
Information provided by:
Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT00596414
First received: January 8, 2008
Last updated: January 16, 2008
Last verified: December 2007

January 8, 2008
January 16, 2008
May 2003
October 2005   (final data collection date for primary outcome measure)
Patient tolerance to the procedure [ Time Frame: 1 hour after the procedure ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00596414 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial
Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Cirrhosis
  • Chronic Hepatitis
  • Anxiety
  • Procedure: transjugular liver biopsy
    liver biopsy through the transjugular route with hepatic-venous pressure gradient measurement
  • Drug: placebo
  • Drug: midazolam
  • Drug: midazolam + pethidine
  • Placebo Comparator: 1
    Interventions:
    • Procedure: transjugular liver biopsy
    • Drug: placebo
  • Experimental: 2
    midazolam
    Interventions:
    • Procedure: transjugular liver biopsy
    • Drug: midazolam
  • Experimental: 3
    midazolam + pethidine
    Interventions:
    • Procedure: transjugular liver biopsy
    • Drug: midazolam + pethidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
October 2005
October 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • suspected liver disease
  • known liver disease

Exclusion Criteria:

  • liver transplants
  • hepatocellular carcinoma
  • hypersensitivity or allergy to benzodiazepines or morphinic derivatives
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00596414
BHTJ-1, BHTJ-1
Yes
Olivier Le Moine, MD, PhD, Erasme University Hospital
Erasme University Hospital
Not Provided
Not Provided
Erasme University Hospital
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP