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

Sponsor

Erasme University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00596414

Collaborator

(none)

180

Enrollment

Location

Arms

Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

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 Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2003

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Oct 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Patient tolerance to the procedure [1 hour after the procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hopital Erasme - Dpt of Gastroenterology	Brussels		Belgium	1070

Sponsors and Collaborators

Erasme University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00596414

Other Study ID Numbers:

BHTJ-1
BHTJ-1

First Posted:

Jan 17, 2008

Last Update Posted:

Jan 17, 2008

Last Verified:

Dec 1, 2007

Keywords provided by , ,

liver

biopsy

Additional relevant MeSH terms:

Hepatitis, Chronic

Midazolam

Meperidine

Study Results

No Results Posted as of Jan 17, 2008