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

Free University of Brussels (ULB)

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis; Cirrhosis; Anxiety

Treatments: Drug: midazolam; Procedure: transjugular liver biopsy; Drug: placebo; Drug: midazolam + pethidine

Study type: Interventional

Funder types: Other

Identifiers

NCT00596414

BHTJ-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• suspected liver disease
• known liver disease

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

180 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: placebo

Procedure: transjugular liver biopsy

2

Experimental group

Description:

midazolam

Treatment:

Procedure: transjugular liver biopsy

Drug: midazolam

3

Experimental group

Description:

midazolam + pethidine

Treatment:

Procedure: transjugular liver biopsy

Drug: midazolam + pethidine