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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596414
• Other study ID #: BHTJ-1
• Secondary ID: BHTJ-1
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2008
• Last updated: January 16, 2008
• Start date: May 2003
• Est. completion date: October 2005

Study information

• Verified date: December 2007
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• suspected liver disease

• known liver disease

Exclusion Criteria:

• liver transplants

• hepatocellular carcinoma

• hypersensitivity or allergy to benzodiazepines or morphinic derivatives

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Chronic Hepatitis
• Cirrhosis
• Hepatitis, Chronic

Intervention

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

Drug:
• placebo

• midazolam

• midazolam + pethidine

Locations

Country	Name	City	State
Belgium	Hopital Erasme - Dpt of Gastroenterology	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient tolerance to the procedure		1 hour after the procedure	Yes