Clinical trial NCT00219856: Effects of Propofol on Oxidative Stress and Liver Regeneration After Partial Hepatectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatectomy
Keywords: Propofol
Hepatectomy
Oxidative stress
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2005-09-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Plasma MDA levels
timeFrame: 30 minutes after the end of hepatic clamping
Secondary outcomes:
measure: Kinetics of post surgical biological hepatic function recovery
timeFrame: Days 1, 2, 5, 10
measure: Kinetics of post surgical hepatic function recovery
timeFrame: Day 2
measure: Other biological markers of oxidative stress
timeFrame: Days 1 and 2
measure: Hemodynamics during and after surgery
timeFrame: Days 1 and 2
measure: Surgery related complications
timeFrame: 10 days
Other outcomes:
Locations:
city: Rennes
country: France
facility: Surgical Intensive Care Unit - Rennes University Hospital
Study officials:
affiliation: Rennes University Hospital
name: David Aguillon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Yannick Malledant, MD
role: STUDY_DIRECTOR
affiliation: Rennes University Hospital
name: Bruno Laviolle, MD
role: STUDY_CHAIR
References: