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

January 16, 2008 updated by: Erasme University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Hopital Erasme - Dpt of Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • suspected liver disease
  • known liver disease

Exclusion Criteria:

  • liver transplants
  • hepatocellular carcinoma
  • hypersensitivity or allergy to benzodiazepines or morphinic derivatives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 1
Drug: placebo
Procedure: transjugular liver biopsy
liver biopsy through the transjugular route with hepatic-venous pressure gradient measurement
EXPERIMENTAL: 2
midazolam
Drug: midazolam
Procedure: transjugular liver biopsy
liver biopsy through the transjugular route with hepatic-venous pressure gradient measurement
EXPERIMENTAL: 3
midazolam + pethidine
Procedure: transjugular liver biopsy
liver biopsy through the transjugular route with hepatic-venous pressure gradient measurement
Drug: midazolam + pethidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient tolerance to the procedure
Time Frame: 1 hour after the procedure
1 hour after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (ACTUAL)

October 1, 2005

Study Completion (ACTUAL)

October 1, 2005

Study Registration Dates

First Submitted

January 8, 2008

First Submitted That Met QC Criteria

January 16, 2008

First Posted (ESTIMATE)

January 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 17, 2008

Last Update Submitted That Met QC Criteria

January 16, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHTJ-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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