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
Overview
- Phase
- Phase 3
- Intervention
- Propofol
- Conditions
- Hepatectomy
- Sponsor
- Rennes University Hospital
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Plasma MDA levels
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Arms & Interventions
1
Anesthesic induction and maintenance with intravenous propofol.
Intervention: Propofol
2
Anesthesic induction with intravenous penthotal and maintenance with inhaled desflurane.
Intervention: Penthotal
2
Anesthesic induction with intravenous penthotal and maintenance with inhaled desflurane.
Intervention: Desflurane
Outcomes
Primary Outcomes
Plasma MDA levels
Time Frame: 30 minutes after the end of hepatic clamping
Secondary Outcomes
- Surgery related complications(10 days)
- Kinetics of post surgical biological hepatic function recovery(Days 1, 2, 5, 10)
- Kinetics of post surgical hepatic function recovery(Day 2)
- Hemodynamics during and after surgery(Days 1 and 2)
- Other biological markers of oxidative stress(Days 1 and 2)