Effects of Propofol on Oxidative Stress and Liver Regeneration After Partial Hepatectomy
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
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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-
-
Rennes, France, 35033
- Surgical Intensive Care Unit - Rennes University Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 1
Anesthesic induction and maintenance with intravenous propofol.
|
|
|
Comparateur actif: 2
Anesthesic induction with intravenous penthotal and maintenance with inhaled desflurane.
|
Intravenous penthotal at the dose of 3 to 5 mg/kg
Inhaled desflurane aiming an alveolar concentration of 4 to 6 per cent.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Plasma MDA levels
Délai: 30 minutes after the end of hepatic clamping
|
30 minutes after the end of hepatic clamping
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Kinetics of post surgical biological hepatic function recovery
Délai: Days 1, 2, 5, 10
|
|
Days 1, 2, 5, 10
|
|
Kinetics of post surgical hepatic function recovery
Délai: Day 2
|
Monoethylglycinexylidide (MEGX) test
|
Day 2
|
|
Other biological markers of oxidative stress
Délai: Days 1 and 2
|
|
Days 1 and 2
|
|
Hemodynamics during and after surgery
Délai: Days 1 and 2
|
|
Days 1 and 2
|
|
Surgery related complications
Délai: 10 days
|
|
10 days
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Yannick Malledant, MD, Rennes University Hospital
- Chaise d'étude: Bruno Laviolle, MD, Rennes University Hospital
- Chercheur principal: David Aguillon, MD, Rennes University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AFSSAPS 040366
- PHRC/03-02 (Autre identifiant: Rennes University Hospital)
- CIC0203/026
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