Skip to main content
OpenTrials
Completed

NCT Number: NCT00596414

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cirrhosis Anxiety Anxiety Disorders Chronic Disease Chronic Hepatitis Digestive System Diseases Disease Attributes Fibrosis Hepatitis Hepatitis, Chronic Liver Diseases Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Erasme - Dpt of Gastroenterology

Brussels, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • suspected liver disease
  • known liver disease

Exclusion criteria

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

Treatment and study plan

transjugular liver biopsy

Procedure

liver biopsy through the transjugular route with hepatic-venous pressure gradient measurement

Placebo

Drug

midazolam

Drug

midazolam + pethidine

Drug

Primary outcomes

  1. Patient tolerance to the procedure

    Time frame: 1 hour after the procedure

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jan 17, 2008
Registry last updated
Jan 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.