Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT05185167
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2021-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Genotoxicity of Desflurane and Propofol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000777', 'term': 'Anesthetics'}], 'ancestors': [{'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2021-12-06', 'studyFirstSubmitQcDate': '2022-01-06', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire', 'timeFrame': 'Before anesthesia induction', 'description': 'The blood samples that evaluate with comet analysis aim to detect the intensity of the DNA tail, and the tail greater, the greater the damage.'}, {'measure': 'Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire', 'timeFrame': '2 hours after anesthesia induction', 'description': 'The blood samples that evaluate with comet analysis aim to detect the intensity of the DNA tail, and the tail greater, the greater the damage.'}, {'measure': 'Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire', 'timeFrame': 'postoperative 1st day', 'description': 'The blood samples that evaluate with comet analysis aim to detect the intensity of the DNA tail, and the tail greater, the greater the damage.'}, {'measure': 'Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire', 'timeFrame': 'postoperative 5th day', 'description': 'The blood samples that evaluate with comet analysis aim to detect the intensity of the DNA tail, and the tail greater, the greater the damage.'}, {'measure': 'Head length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire', 'timeFrame': 'Before anesthesia induction', 'description': 'The blood samples that evaluate with comet analysis aim to detect the head length of DNA, the head greater, the smaller the damage.'}, {'measure': 'Head length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire', 'timeFrame': '2 hours after anesthesia induction', 'description': 'The blood samples that evaluate with comet analysis aim to detect the head length of DNA, the head greater, the smaller the damage.'}, {'measure': 'Head length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire', 'timeFrame': 'postoperative 1 st day', 'description': 'The blood samples that evaluate with comet analysis aim to detect the head length of DNA, the head greater, the smaller the damage.'}, {'measure': 'Head length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire', 'timeFrame': 'postoperative 5th day', 'description': 'The blood samples that evaluate with comet analysis aim to detect the head length of DNA, the head greater, the smaller the damage.'}, {'measure': 'Tail length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire', 'timeFrame': 'before anesthesia induction', 'description': 'The blood samples that evaluate with comet analysis aim to detect the tail length of DNA, the head greater, the greater the damage.'}, {'measure': 'Tail length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire', 'timeFrame': '2 hours after anesthesia induction', 'description': 'The blood samples that evaluate with comet analysis aim to detect the tail length of DNA, the head greater, the greater the damage.'}, {'measure': 'Tail length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire', 'timeFrame': 'postoperative 1 st day', 'description': 'The blood samples that evaluate with comet analysis aim to detect the tail length of DNA, the head greater, the greater the damage.'}, {'measure': 'Tail length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire', 'timeFrame': 'postoperative 5th day', 'description': 'The blood samples that evaluate with comet analysis aim to detect the tail length of DNA, the head greater, the greater the damage.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Desflurane', 'Intravenous anesthetics', 'propofol', 'comet essay'], 'conditions': ['DNA Damage', 'Anesthesia']}, 'referencesModule': {'references': [{'pmid': '38734439', 'type': 'DERIVED', 'citation': 'Toker MK, Altiparmak B, Gursoy G, Uysal AI, Dede G, Gundogdu G, Dodurga Y, Ugur B. Comparison of the genotoxicity of propofol and desflurane using the comet assay in the lymphocytes of patients who underwent lumbar discectomy: A randomized trial. Saudi Med J. 2024 May;45(5):468-475. doi: 10.15537/smj.2024.45.5.20240077.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if the anesthetics propofol and desflurane can damage DNA according to comet essay in patients submitted to lumbar disc surgery.', 'detailedDescription': 'It is expected that DNA damage information provide the possible genotoxic effects of inhalational and intravenous anesthetics and contribute to the establishment of strategies aimed at reducing the risks to exposed patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to understand and willingness to sign an informed consent form\n2. Elective lumbar spinal surgery that will take at least 120 minutes,\n3. American Society of Anesthesiologists (ASA) physical status I and II\n\nExclusion Criteria:\n\n1. Patients with ASA physical status III or IV disease\n2. Chronic systemic disease (diabetes mellitus,chronic pulmonary disorders, chronic kidney and liver disorders)\n3. Smoking or alcohol consumption\n4. Recently received radiation, chemotherapy\n5. Malignancy\n6. Patients who will receive blood transfusion during the operation\n7. Users of antioxidant supplements\n8. Patients who have received general anesthesia in the last three months\n9. Patients with known occupational exposures (operating room personnel, chemical plant worker'}, 'identificationModule': {'nctId': 'NCT05185167', 'briefTitle': 'Comparison of the Genotoxicity of Desflurane and Propofol', 'organization': {'class': 'OTHER', 'fullName': 'Muğla Sıtkı Koçman University'}, 'officialTitle': 'Genotoxic Effects of Desflurane and Propofol Anesthesia in Patients Undergoing Lumbar Disc Surgery', 'orgStudyIdInfo': {'id': 'MSKU 05/III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desflurane Group', 'description': 'Desflurane 1,0 minimum alveolar concentration will be administered during anesthesia maintenance', 'interventionNames': ['Drug: Anesthetics, General Desflurane Maintenance']}, {'type': 'EXPERIMENTAL', 'label': 'Propofol Group', 'description': 'Propofol 6 mg//kg/hour will be administered during anesthesia maintenance', 'interventionNames': ['Drug: Anesthetics, General Propofol Maintenance']}], 'interventions': [{'name': 'Anesthetics, General Desflurane Maintenance', 'type': 'DRUG', 'description': 'Comparison of dna damage of desflurane maintenance with propofol maintenance according to comet analysis', 'armGroupLabels': ['Desflurane Group']}, {'name': 'Anesthetics, General Propofol Maintenance', 'type': 'DRUG', 'description': 'Comparison of dna damage of propofol maintenance with desflurane maintenance according to comet analysis', 'armGroupLabels': ['Propofol Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48000', 'city': 'Muğla', 'country': 'Turkey (Türkiye)', 'facility': 'Mugla Sitki Kocman University', 'geoPoint': {'lat': 37.21807, 'lon': 28.3665}}], 'overallOfficials': [{'name': 'Melike Korkmaz Toker, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mugla Sıtkı Kocman University Department of Anesthesiology and reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muğla Sıtkı Koçman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Melike Korkmaz Toker', 'investigatorAffiliation': 'Muğla Sıtkı Koçman University'}}}}