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Effects of Propofol on Oxidative Stress and Liver Regeneration After Partial Hepatectomy

NCT00219856 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2012-06-26

No results posted yet for this study

Summary

Propofol is an anaesthetic agent that showed in vitro and in vivo anti oxidant properties. No data are available concerning the potential benefit of a total anaesthesia with propofol in partial hepatic surgery. Patients who undergo partial hepatic resection have frequent liver insufficiency that could be related in part to the oxidative stress induced by clamping the hepatic vessels during the surgical intervention. Our hypothesis is that propofol, by increasing liver resistance to this ischemia-reperfusion phenomenon, could improve the remaining liver function recovery, and therefore could reduce post surgical morbidity.

The aim of the study is to evaluate the anti oxidant effects of propofol compared to another widely used anaesthetic agent, inhaled desflurane, during and after partial hepatic resection with hepatic vessels clamping. The primary endpoint will be the level of malondialdehyde (a plasmatic marker of oxidative stress), 30 minutes after the end of hepatic clamping.

Conditions

  • Hepatectomy

Interventions

DRUG

Propofol

* Induction : intravenous propofol aiming a concentration of 4 to 8 µg/ml * Maintenance : intravenous propofol aiming a concentration of 3 to 6 µg/ml

DRUG

Penthotal

Intravenous penthotal at the dose of 3 to 5 mg/kg

DRUG

Desflurane

Inhaled desflurane aiming an alveolar concentration of 4 to 6 per cent.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • David Aguillon, MD · Rennes University Hospital

  • Yannick Malledant, MD · Rennes University Hospital

  • Bruno Laviolle, MD · Rennes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2006-03-31
Completion
2006-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00219856 on ClinicalTrials.gov