Effects of Propofol on Oxidative Stress and Liver Regeneration After Partial Hepatectomy

Rennes University Hospital

Status and phase: Completed; Phase 3

Conditions: Hepatectomy

Treatments: Drug: Propofol; Drug: Desflurane; Drug: Penthotal

Study type: Interventional

Funder types: Other

Identifiers

NCT00219856

CIC0203/026

AFSSAPS 040366

PHRC/03-02 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

1

Experimental group

Description:

Anesthesic induction and maintenance with intravenous propofol.

Treatment:

Drug: Propofol

2

Active Comparator group

Description:

Anesthesic induction with intravenous penthotal and maintenance with inhaled desflurane.

Treatment:

Drug: Penthotal

Drug: Desflurane