Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial - Full Text View

Sponsor:	Erasme University Hospital
Information provided by:	Erasme University Hospital
ClinicalTrials.gov Identifier:	NCT00596414

Purpose

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	Intervention	Phase
Cirrhosis Chronic Hepatitis Anxiety	Procedure: transjugular liver biopsy Drug: placebo Drug: midazolam Drug: midazolam + pethidine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Anxiety Cirrhosis Hepatitis Hepatitis A

Drug Information available for: Meperidine hydrochloride Meperidine Midazolam Midazolam maleate Midazolam hydrochloride

U.S. FDA Resources

Further study details as provided by Erasme University Hospital:

Primary Outcome Measures:

Patient tolerance to the procedure [ Time Frame: 1 hour after the procedure ] [ Designated as safety issue: Yes ]

Enrollment:	180
Study Start Date:	May 2003
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596414

Locations

Belgium
Hopital Erasme - Dpt of Gastroenterology
Brussels, Belgium, 1070

Sponsors and Collaborators

Erasme University Hospital

More Information

No publications provided

Responsible Party:	Olivier Le Moine, MD, PhD, Erasme University Hospital
ClinicalTrials.gov Identifier:	NCT00596414 History of Changes
Other Study ID Numbers:	BHTJ-1, BHTJ-1
Study First Received:	January 8, 2008
Last Updated:	January 16, 2008
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Erasme University Hospital:

liver
biopsy

Additional relevant MeSH terms:

Anxiety Disorders
Hepatitis
Hepatitis A
Hepatitis, Chronic
Liver Cirrhosis
Fibrosis
Mental Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pathologic Processes

Meperidine
Midazolam
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Adjuvants, Anesthesia
Narcotics
Anti-Anxiety Agents
Tranquilizing Agents

ClinicalTrials.gov processed this record on February 12, 2012