Ignite Creation Date:
2025-12-17 @ 1:46 PM
Ignite Modification Date:
2025-12-23 @ 4:53 PM
Study NCT ID:
NCT02056561
Status:
COMPLETED
Last Update Posted:
2014-02-06
First Post:
2014-01-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects on Immun System of Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Before induction and after the operation venous blood samples were taken.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'targetDuration': '3 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-05', 'studyFirstSubmitDate': '2014-01-29', 'studyFirstSubmitQcDate': '2014-02-05', 'lastUpdatePostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of glutathion peroxidase, total oxidants and antioxidants.', 'timeFrame': '24 hours', 'description': 'Before induction and after the operation venous blood samples were taken to evaluate the levels of glutathion peroxidase, total oxidants and antioxidants.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Oxidants', 'Antioxidants'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Introduction and Aim: Desflurane and sevoflurane are frequently used for maintenance of anesthesia and studies have shown that these anesthetics cause a variety of changes in oxidative stress and antioxidative defense mechanisms. The chemical structure of propofol is similar to some free radical consumers such as endogenous vitamin E and butylated hydroxene toluene. This study aims to compare the effects of sevoflurane, desflurane and propofol infusion anesthesia on the oxidant and antioxidant systems of patients undergoing laparoscopic cholecystectomy.\n\nMaterial and Method: Forty-five patients, ASA (American Society of Anesthesiologists) I-II, score between 18-50 years with planned laparoscopic cholecystectomy under general anesthesia were included in the study. Patients were divided into 3 groups as total intravenous anesthesia (TIVA) (group T n: 15), sevoflurane (group S n: 15) and desflurane (group D n: 15). Propofol 2 mg/kg IV, fentanyl 1 mcg/kg IV, vecuronium 0.1 mg/kg IV given to all groups for anesthesia induction. For maintenance of anesthesia group S were ventilated with 2% sevoflurane, 50% air and 50% O2 mix at 6 L/min flow. Group D were given 6% desflurane 50% air and 50% O2 mix at 6 L/min flow. Group T were given propofol infusions of 12 mg/kg/hr for the first 10 minutes, 9 mg/kg/hr for the second 10 minutes and 6 mg/kg/hr after that. Patients were ventilated with 50% air and 50% O2 mix at 6 L/min flow. Before induction and after the operation venous blood samples were taken to evaluate the levels of glutathion peroxidase, total oxidants and antioxidants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '45 patients ASA I-II between 18-50 years with planned laparoscopic cholecystectomy under general anesthetic were included in the study. Patients were divided into 3 groups on the way to surgery; TIVA (group T n: 15), sevoflurane (group S n: 15) and desflurane (group D n: 15).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II with patients\n* Between 18-50 years\n* Planned laparoscopic cholecystectomy under general anesthetic\n\nExclusion Criteria:\n\n* Patients with endocrine dysfunction\n* blood transfusion in the previous 2 weeks\n* signs of infection and inflammation\n* history of preoperative medication use\n* anemia\n* hemorrhage requiring transfusion during the operation were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT02056561', 'briefTitle': 'Effects on Immun System of Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Duzce University'}, 'officialTitle': 'Investigation Of The Effects Of General Anesthesia On The Oxidant/Antioxidant System', 'orgStudyIdInfo': {'id': 'MESUT-81'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TIVA (group T n: 15)', 'description': 'Group T were given propofol infusions of 12 mg/kg/hr for the first 10 minutes, 9 mg/kg/hr for the second 10 minutes and 6 mg/kg/hr after that. Patients were ventilated with 50% air and 50% O2 mix at 6 L/min flow.'}, {'label': 'Sevoflurane (group S n: 15)', 'description': 'Group S were ventilated with 2% sevoflurane, 50% air and 50% O2 mix at 6 L/min flow.'}, {'label': 'Desflurane (group D n: 15)', 'description': 'Group D cases were given 6% desflurane 50% air and 50% O2 mix at 6 L/min flow.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81600', 'city': 'Düzce', 'country': 'Turkey (Türkiye)', 'facility': 'Duzce Univercity Medical Fauculty', 'geoPoint': {'lat': 40.83889, 'lon': 31.16389}}], 'overallOfficials': [{'name': 'yavuz demiraran, MD prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'duzce university medical faculty'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duzce University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor', 'investigatorFullName': 'yavuz demiraran', 'investigatorAffiliation': 'Duzce University'}}}}