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
  Purpose

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.


Condition Intervention Phase
Cirrhosis
Chronic Hepatitis
Anxiety
Procedure: transjugular liver biopsy
Drug: placebo
Drug: midazolam
Drug: midazolam + pethidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Erasme University Hospital:

Primary Outcome Measures:
  • Patient tolerance to the procedure [ Time Frame: 1 hour after the procedure ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: May 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Procedure: transjugular liver biopsy
liver biopsy through the transjugular route with hepatic-venous pressure gradient measurement
Drug: placebo
Experimental: 2
midazolam
Procedure: transjugular liver biopsy
liver biopsy through the transjugular route with hepatic-venous pressure gradient measurement
Drug: midazolam
Experimental: 3
midazolam + pethidine
Procedure: transjugular liver biopsy
liver biopsy through the transjugular route with hepatic-venous pressure gradient measurement
Drug: midazolam + pethidine

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • suspected liver disease
  • known liver disease

Exclusion Criteria:

  • liver transplants
  • hepatocellular carcinoma
  • hypersensitivity or allergy to benzodiazepines or morphinic derivatives
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00596414

Locations
Belgium
Hopital Erasme - Dpt of Gastroenterology
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
  More Information

No publications provided

Responsible Party: Olivier Le Moine, MD, PhD, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT00596414     History of Changes
Other Study ID Numbers: BHTJ-1, BHTJ-1
Study First Received: January 8, 2008
Last Updated: January 16, 2008
Health Authority: Belgium: Institutional Review Board

Keywords provided by Erasme University Hospital:
liver
biopsy

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014