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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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-
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Rennes, Frankrig, 35033
- Surgical Intensive Care Unit - Rennes University Hospital
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
Anesthesic induction and maintenance with intravenous propofol.
|
|
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Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Plasma MDA levels
Tidsramme: 30 minutes after the end of hepatic clamping
|
30 minutes after the end of hepatic clamping
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Kinetics of post surgical biological hepatic function recovery
Tidsramme: 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
Tidsramme: 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
Tidsramme: Days 1 and 2
|
|
Days 1 and 2
|
|
Hemodynamics during and after surgery
Tidsramme: Days 1 and 2
|
|
Days 1 and 2
|
|
Surgery related complications
Tidsramme: 10 days
|
|
10 days
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Yannick Malledant, MD, Rennes University Hospital
- Studiestol: Bruno Laviolle, MD, Rennes University Hospital
- Ledende efterforsker: David Aguillon, MD, Rennes University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AFSSAPS 040366
- PHRC/03-02 (Anden identifikator: Rennes University Hospital)
- CIC0203/026
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