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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00596414

Enrollment

180

Registered

2008-01-17

Start date

2003-05-31

Completion date

2005-10-31

Last updated

2008-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Chronic Hepatitis, Cirrhosis

Keywords

liver, biopsy

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.

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.

Interventions

PROCEDUREtransjugular liver biopsy

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

DRUGplacebo

DRUGmidazolam

DRUGmidazolam + pethidine

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* suspected liver disease * known liver disease

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Patient tolerance to the procedure	1 hour after the procedure

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026