Skip to main content
OpenTrials
Completed

NCT Number: NCT00219856

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Surgical Intensive Care Unit - Rennes University Hospital

Rennes, 35033, France

About this study

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 hilum during the surgical intervention. Our hypothesis is that propofol, by increasing liver resistance to ischemic-reperfusion injury, 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 hilum clamping.

The primary endpoint will be the level of malondialdehyde (a plasmatic marker of oxidative stress), 30 minutes after the end of hepatic clamping.

The evolution over time of other markers of oxidative stress will be studied (glutathione, myeloperoxidase, nitric oxide), as well as functional and biological markers of liver regeneration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18
  • Need for partial hepatic resection requiring heptic clamping
  • Resection of 4 liver segments or less
  • In case of cirrhosis, child A
  • Written informed consent

Non-inclusion Criteria:

  • Hemochromatosis
  • chemotherapy in the previous week before inclusion
  • Thrombosis of the portal vein or the hepatic artery
  • Absence of contraception among fertil woman
  • Concomitant treatment that could have potential interaction with propofol
  • Concomitant treatment known to have antioxidant properties
  • Inclusion in another study protocol using a medication incompatible with the present study
  • Patient in which the follow up seems impossible

Treatment and study plan

Propofol

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

Penthotal

Drug

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

Desflurane

Drug

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

Primary outcomes

  1. Plasma MDA levels

    Time frame: 30 minutes after the end of hepatic clamping

Secondary outcomes

  1. Kinetics of post surgical biological hepatic function recovery

    Time frame: Days 1, 2, 5, 10

    • Gamma gluatamyltransferase
    • ASAT
    • ALAT
    • Factor V
    • AlfagluthationeS-transferase
  2. Kinetics of post surgical hepatic function recovery

    Time frame: Day 2

    Monoethylglycinexylidide (MEGX) test

  3. Other biological markers of oxidative stress

    Time frame: Days 1 and 2

    • Glutathione
    • Myeloperoxidase
    • Nitric oxide
  4. Hemodynamics during and after surgery

    Time frame: Days 1 and 2

    • Mean arterial pressure
    • Heart rate
    • Diuresis
  5. Surgery related complications

    Time frame: 10 days

    • Liver insufficiency
    • Hepato renal syndrome
    • Local infections

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Prospective, Randomized, Simple Blind Study Comparing the Effects of an Anaesthesia With Propofol to an Anaesthesia With Desflurane on Oxydative Stress and Liver Function Recovery After Hepatectomy

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Jun 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.