Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT00219856
Status:
COMPLETED
Last Update Posted:
2012-06-26
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Propofol on Oxidative Stress and Liver Regeneration After Partial Hepatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077335', 'term': 'Desflurane'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005019', 'term': 'Ethyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-25', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma MDA levels', 'timeFrame': '30 minutes after the end of hepatic clamping'}], 'secondaryOutcomes': [{'measure': 'Kinetics of post surgical biological hepatic function recovery', 'timeFrame': 'Days 1, 2, 5, 10', 'description': '* Gamma gluatamyltransferase\n* ASAT\n* ALAT\n* Factor V\n* AlfagluthationeS-transferase'}, {'measure': 'Kinetics of post surgical hepatic function recovery', 'timeFrame': 'Day 2', 'description': 'Monoethylglycinexylidide (MEGX) test'}, {'measure': 'Other biological markers of oxidative stress', 'timeFrame': 'Days 1 and 2', 'description': '* Glutathione\n* Myeloperoxidase\n* Nitric oxide'}, {'measure': 'Hemodynamics during and after surgery', 'timeFrame': 'Days 1 and 2', 'description': '* Mean arterial pressure\n* Heart rate\n* Diuresis'}, {'measure': 'Surgery related complications', 'timeFrame': '10 days', 'description': '* Liver insufficiency\n* Hepato renal syndrome\n* Local infections'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Propofol', 'Hepatectomy', 'Oxidative stress'], 'conditions': ['Hepatectomy']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe primary endpoint will be the level of malondialdehyde (a plasmatic marker of oxidative stress), 30 minutes after the end of hepatic clamping.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18\n* Need for partial hepatic resection requiring heptic clamping\n* Resection of 4 liver segments or less\n* In case of cirrhosis, child A\n* Written informed consent\n\nNon-inclusion Criteria:\n\n* Hemochromatosis\n* chemotherapy in the previous week before inclusion\n* Thrombosis of the portal vein or the hepatic artery\n* Absence of contraception among fertil woman\n* Concomitant treatment that could have potential interaction with propofol\n* Concomitant treatment known to have antioxidant properties\n* Inclusion in another study protocol using a medication incompatible with the present study\n* Patient in which the follow up seems impossible'}, 'identificationModule': {'nctId': 'NCT00219856', 'briefTitle': 'Effects of Propofol on Oxidative Stress and Liver Regeneration After Partial Hepatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AFSSAPS 040366'}, 'secondaryIdInfos': [{'id': 'PHRC/03-02', 'type': 'OTHER', 'domain': 'Rennes University Hospital'}, {'id': 'CIC0203/026'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Anesthesic induction and maintenance with intravenous propofol.', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Anesthesic induction with intravenous penthotal and maintenance with inhaled desflurane.', 'interventionNames': ['Drug: Penthotal', 'Drug: Desflurane']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': '* Induction : intravenous propofol aiming a concentration of 4 to 8 µg/ml\n* Maintenance : intravenous propofol aiming a concentration of 3 to 6 µg/ml', 'armGroupLabels': ['1']}, {'name': 'Penthotal', 'type': 'DRUG', 'description': 'Intravenous penthotal at the dose of 3 to 5 mg/kg', 'armGroupLabels': ['2']}, {'name': 'Desflurane', 'type': 'DRUG', 'description': 'Inhaled desflurane aiming an alveolar concentration of 4 to 6 per cent.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'Surgical Intensive Care Unit - Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'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', 'affiliation': 'Rennes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Direction of Clinical Research', 'oldOrganization': 'Rennes University Hospital'}}}}