A Phase 3 interventional study of Propofol and Penthotal in Hepatectomy, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-26.
Sponsored by Rennes University Hospital · Phase 3, Interventional, and Treatment
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.
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.
Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.
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Inclusion Criteria:
Non-inclusion Criteria:
Anesthesic induction and maintenance with intravenous propofol.
Drug: Propofol
Anesthesic induction with intravenous penthotal and maintenance with inhaled desflurane.
Drug: Penthotal · Drug: Desflurane
* Induction : intravenous propofol aiming a concentration of 4 to 8 µg/ml * Maintenance : intravenous propofol aiming a concentration of 3 to 6 µg/ml
Intravenous penthotal at the dose of 3 to 5 mg/kg
Inhaled desflurane aiming an alveolar concentration of 4 to 6 per cent.
Plasma MDA levels
Time frame: 30 minutes after the end of hepatic clamping
Kinetics of post surgical biological hepatic function recovery
* Gamma gluatamyltransferase * ASAT * ALAT * Factor V * AlfagluthationeS-transferase
Time frame: Days 1, 2, 5, 10
Kinetics of post surgical hepatic function recovery
Monoethylglycinexylidide (MEGX) test
Time frame: Day 2
Other biological markers of oxidative stress
* Glutathione * Myeloperoxidase * Nitric oxide
Time frame: Days 1 and 2
Hemodynamics during and after surgery
* Mean arterial pressure * Heart rate * Diuresis
Time frame: Days 1 and 2
Surgery related complications
* Liver insufficiency * Hepato renal syndrome * Local infections
Time frame: 10 days
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Rennes University Hospital