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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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-
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Rennes, Frankreich, 35033
- Surgical Intensive Care Unit - Rennes University Hospital
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 1
Anesthesic induction and maintenance with intravenous propofol.
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Aktiver Komparator: 2
Anesthesic induction with intravenous penthotal and maintenance with inhaled desflurane.
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Intravenous penthotal at the dose of 3 to 5 mg/kg
Inhaled desflurane aiming an alveolar concentration of 4 to 6 per cent.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Plasma MDA levels
Zeitfenster: 30 minutes after the end of hepatic clamping
|
30 minutes after the end of hepatic clamping
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Kinetics of post surgical biological hepatic function recovery
Zeitfenster: Days 1, 2, 5, 10
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Days 1, 2, 5, 10
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Kinetics of post surgical hepatic function recovery
Zeitfenster: Day 2
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Monoethylglycinexylidide (MEGX) test
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Day 2
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Other biological markers of oxidative stress
Zeitfenster: Days 1 and 2
|
|
Days 1 and 2
|
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Hemodynamics during and after surgery
Zeitfenster: Days 1 and 2
|
|
Days 1 and 2
|
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Surgery related complications
Zeitfenster: 10 days
|
|
10 days
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienleiter: Yannick Malledant, MD, Rennes University Hospital
- Studienstuhl: Bruno Laviolle, MD, Rennes University Hospital
- Hauptermittler: David Aguillon, MD, Rennes University Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- AFSSAPS 040366
- PHRC/03-02 (Andere Kennung: Rennes University Hospital)
- CIC0203/026
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