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

NCT00219856 | Completed Phase 3

• 3 other identifiers: AFSSAPS 040366PHRC/03-02CIC0203/026
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatectomy

Keywords

Propofol; Hepatectomy; Oxidative stress

Outcome Measures

Primary Outcomes (1)

• Plasma MDA levels

  30 minutes after the end of hepatic clamping

Secondary Outcomes (5)

• Kinetics of post surgical biological hepatic function recovery

  Days 1, 2, 5, 10

• Kinetics of post surgical hepatic function recovery

  Day 2

• Other biological markers of oxidative stress

  Days 1 and 2

• Hemodynamics during and after surgery

  Days 1 and 2

• Surgery related complications

  10 days

Study Arms (2)

1

EXPERIMENTAL

Anesthesic induction and maintenance with intravenous propofol.

Drug: Propofol

2

ACTIVE COMPARATOR

Anesthesic induction with intravenous penthotal and maintenance with inhaled desflurane.

Drug: Penthotal; Drug: Desflurane

Interventions

Propofol DRUG

* Induction : intravenous propofol aiming a concentration of 4 to 8 µg/ml * Maintenance : intravenous propofol aiming a concentration of 3 to 6 µg/ml

1

Penthotal DRUG

Intravenous penthotal at the dose of 3 to 5 mg/kg

2

Desflurane DRUG

Inhaled desflurane aiming an alveolar concentration of 4 to 6 per cent.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Hemochromatosis
• 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
• Patient in which the follow up seems impossible

Sponsors & Collaborators

• Rennes University Hospital: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Surgical Intensive Care Unit - Rennes University Hospital

Rennes, 35033, France

Location

MeSH Terms

Interventions

Propofol; Desflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• David Aguillon, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

• Yannick Malledant, MD

  Rennes University Hospital

  STUDY DIRECTOR

• Bruno Laviolle, MD

  Rennes University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: June 26, 2012

Record last verified: 2012-06

Locations

FR (1)