Hepatectomy
Conditions
Keywords
Propofol, Hepatectomy, Oxidative stress
Brief 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.
Detailed description
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.
Interventions
DRUGPropofol
* Induction : intravenous propofol aiming a concentration of 4 to 8 µg/ml * Maintenance : intravenous propofol aiming a concentration of 3 to 6 µg/ml
DRUGPenthotal
Intravenous penthotal at the dose of 3 to 5 mg/kg
DRUGDesflurane
Inhaled desflurane aiming an alveolar concentration of 4 to 6 per cent.
Sponsors
Ministry of Health, France
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma MDA levels | 30 minutes after the end of hepatic clamping |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kinetics of post surgical biological hepatic function recovery | Days 1, 2, 5, 10 | * Gamma gluatamyltransferase * ASAT * ALAT * Factor V * AlfagluthationeS-transferase |
| Kinetics of post surgical hepatic function recovery | Day 2 | Monoethylglycinexylidide (MEGX) test |
| Other biological markers of oxidative stress | Days 1 and 2 | * Glutathione * Myeloperoxidase * Nitric oxide |
| Hemodynamics during and after surgery | Days 1 and 2 | * Mean arterial pressure * Heart rate * Diuresis |
| Surgery related complications | 10 days | * Liver insufficiency * Hepato renal syndrome * Local infections |
Countries
France
Outcome results
None listed