Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial
Phase 4
Completed
- Conditions
- Chronic HepatitisAnxietyCirrhosis
- Interventions
- Registration Number
- NCT00596414
- Lead Sponsor
- Erasme University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
- suspected liver disease
- known liver disease
Exclusion Criteria
- liver transplants
- hepatocellular carcinoma
- hypersensitivity or allergy to benzodiazepines or morphinic derivatives
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 transjugular liver biopsy - 1 placebo - 2 transjugular liver biopsy midazolam 3 midazolam + pethidine midazolam + pethidine 3 transjugular liver biopsy midazolam + pethidine 2 midazolam midazolam
- Primary Outcome Measures
Name Time Method Patient tolerance to the procedure 1 hour after the procedure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hopital Erasme - Dpt of Gastroenterology
🇧🇪Brussels, Belgium