NCT00596414

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cirrhosis
• Chronic Hepatitis
• Anxiety

Interventions

Type	Name	Description
PROCEDURE	transjugular liver biopsy	liver biopsy through the transjugular route with hepatic-venous pressure gradient measurement
DRUG	placebo
DRUG	midazolam
DRUG	midazolam + pethidine

Timeline

• Start date: 2003-05-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2008-01-17
• Last updated: 2008-01-17

Locations

1 site across 1 country: Belgium