Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT00908518
Status:
UNKNOWN
Last Update Posted:
2009-05-27
First Post:
2009-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Difference in Postoperative Cognitive Dysfunction and Myocardial Ischemia Between Propofol and Isoflurane
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-05-26', 'studyFirstSubmitDate': '2009-05-26', 'studyFirstSubmitQcDate': '2009-05-26', 'lastUpdatePostDateStruct': {'date': '2009-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to evaluate whether there is a difference in the occurrence of POCD', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'To evaluate whether there is a difference in the occurrence of post-operative cardiac morbidity', 'timeFrame': '3 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cognitive dysfunction', 'Cardiac morbidity', 'anesthesia'], 'conditions': ['Cognitive Dysfunction', 'Cardiac Morbidity']}, 'descriptionModule': {'briefSummary': "The progressive aging of the general population cause increase in number of extensive and long surgeries in older patients. Age is a risk factor for perioperative myocardial ischemia and Postoperative Cognitive Dysfunction (POCD) The suggested study will deal with the above-mentioned complication in patients older then 65 years undergoing major non-cardiac surgeries.\n\nIt has been shown that Isoflurane and sevoflurane may have a cardio-protective effect after cardiac surgery involving cardio-pulmonary bypass, and it was recommended that isoflurane should be used in these cases. A question was raised but haven't been answered yet, whether this cardio-protective effect exists also in non-cardiac major surgery.\n\nThe aim of this study is to evaluate whether there is a difference in the occurrence of postoperative cognitive dysfunction and perioperative myocardial ischemia between total intravenous anesthesia using propofol and isoflurane based anesthesia.", 'detailedDescription': "The progressive aging of the general population cause increase in number of extensive and long surgeries in older patients. Age is a risk factor for perioperative myocardial ischemia and Postoperative Cognitive Dysfunction (POCD) The suggested study will deal with the above-mentioned complication in patients older then 65 years undergoing major non-cardiac surgeries.\n\nIt has been shown that Isoflurane and sevoflurane may have a cardio-protective effect after cardiac surgery involving cardio-pulmonary bypass, and it was recommended that isoflurane should be used in these cases. A question was raised but haven't been answered yet, whether this cardio-protective effect exists also in non-cardiac major surgery.\n\nThe aim of this study is to evaluate whether there is a difference in the occurrence of postoperative cognitive dysfunction and perioperative myocardial ischemia between total intravenous anesthesia using propofol and isoflurane based anesthesia.\n\nThe suggested study is a randomized controlled study. 500 patients older then 65 years undergoing elective non-cardiac major surgeries will be studied.\n\nOn the day prior to surgery the patient will take a series computerized cognitive tests (Mindstream® cognitive health assessment, neurotrax®, Modiin, Israel). At the holding area before entering the operating room (OR) the patients will be randomly assigned to one of two study groups.\n\nGroup 1 -IA: anesthesia will be maintained using Isoflurane carried by O2/air. Group 2 - TIVA : anesthesia will be maintained with propofol. The patients will be followed for 3 months post-operatively. Cognitive function will be assessed 7 days and 3 months postoperatively using computerized tests and telephone interview."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '500 patients older then 65 year, scheduled for elective non-cardiac, non-neuro surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that refuse or unable to sign an informed consent\n\nExclusion Criteria:\n\n* Patients with any unstable disease\n* Patients treated with medication affecting the nervous system\n* Patients with earring difficulty\n* Patients that will not be able to participate in the study due to language barrier'}, 'identificationModule': {'nctId': 'NCT00908518', 'acronym': 'POCD', 'briefTitle': 'The Difference in Postoperative Cognitive Dysfunction and Myocardial Ischemia Between Propofol and Isoflurane', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Postoperative Cognitive Dysfunction and Perioperative Myocardial Ischemia: Comparing Total IV Anesthesia and Inhalation Anesthesia.', 'orgStudyIdInfo': {'id': 'TASMC-08-RF-514-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Total Intravenous Anesthesia', 'description': 'Propofol based anesthesia'}, {'label': 'Inhaled anesthesia', 'description': 'Isoflurane based anesthesia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'contacts': [{'name': 'Ron Flaishon, MD', 'role': 'CONTACT', 'email': 'flaishon@post.tau.ac.il', 'phone': '972-52-4266496'}, {'name': 'Ron Flaishon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Ron Flaishon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel-Aviv Sourasky Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Tel Aviv University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Ron Flaishon MD', 'oldOrganization': 'Tel Aviv Sourasky Medical Center'}}}}