Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-28 @ 11:16 AM
Study NCT ID:
NCT03563833
Status:
UNKNOWN
Last Update Posted:
2018-06-20
First Post:
2018-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Minimal and High Flow Anesthesia on Thiol Disulfide Balance and StO2 in Hypotensive Anesthesia Applications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-19', 'studyFirstSubmitDate': '2018-05-20', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thiol Disulfide Balance', 'timeFrame': 'For two groups; First blood sample will be taken 30 min before the start of surgery, second blood sample will be taken at the 60th min of the surgery', 'description': 'Change of Oxidative Stress Marker'}], 'secondaryOutcomes': [{'measure': 'StO2', 'timeFrame': 'For two groups; simultaneously, 30 min before the start of surgery, 60th min of the surgery', 'description': 'Change of Peripheral Tissue Oxygen Saturation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Minimal Flow Anesthesia', 'Thiol/disulfide balance', 'Tissue oxygen saturation', 'hypotensive anesthesia'], 'conditions': ['Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'The effects of Minimal Flow Anesthesia (0.4 l / min) and High Flow Anaesthesia (2 l / min) on tissue oxygen saturation (St02) and thiol / disulfide balance in hypotensive anesthesia operations will be investigated.', 'detailedDescription': 'The oxidative stress at the cellular level and the possible effects of general anesthesia techniques on the antioxidant system make the method of anesthesia more important.\n\nThe effects of Minimal Flow Anesthesia (0.4 l / min) and High Flow Anaesthesia (2 l / min) on tissue oxygen saturation (St02) and thiol / disulfide balance in hypotensive anesthesia operations will be investigated.\n\nMinimal flow anesthesia is widely used because of its advantages such as cost reduction, prevention of environmental pollution, minimization of heat and humidity loss.\n\nHypotensive anesthesia is preferred in some specialized surgical procedures in order to reduce bleeding and improve the surgical field of view.\n\nThe use of hypotensive anesthesia and inhalation agents may cause hypoperfusion at the tissue level and cause hypoxia-induced oxidative stress and initiate cell damage.\n\nDetermining the ideal anesthesia technique in terms of oxidative stress and tissue perfusion will reduce intra- and postoperative risks by protecting patients from the harmful effects of anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA (American Society of Anesthesiologists) I tympanoplasty operations with hypotensive anesthesia,\n* ASA (American Society of Anesthesiologists) II tympanoplasty operations with hypotensive anesthesia,\n\nExclusion Criteria:\n\n* operations in less than one hour\n* uncontrolled hypertension\n* DM (Diabetes Mellitus)\n* cerebrovascular disease\n* coagulopathy\n* morbid obesity ((BMI ≥ 35)\n* renal disease'}, 'identificationModule': {'nctId': 'NCT03563833', 'briefTitle': 'Effects of Minimal and High Flow Anesthesia on Thiol Disulfide Balance and StO2 in Hypotensive Anesthesia Applications', 'organization': {'class': 'OTHER', 'fullName': 'Recep Tayyip Erdogan University Training and Research Hospital'}, 'officialTitle': 'Investigation of the Effects of Minimal and High Flow Anesthesia on Thiol Disulfide Balance and Peripheral Tissue Saturation (StO2) in Hypotensive Anesthesia Applications', 'orgStudyIdInfo': {'id': '2018/64'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Minimal Flow Anesthesia', 'description': 'Minimal Flow Anesthesia (50% O2, 50% air), Desflurane (MAC = 4,5). In hypotensive anesthesia application; Remifentanil will be used at infusion rates of 0.025-0.1μg / kg / min after a loading dose of 1 μg / kg / min, with mean Arterial Pressure 55-65 mmHg.\n\nBefore the induction of anesthesia and 30 minutes of anesthesia, 2 ml of venous blood sample will be taken from the patients and simultaneous tissue oxygen saturation will be recorded. Serum thiol disulfide levels obtained from the blood sample of the recipient will be studied in the biochemistry research laboratory using the method developed by Erel et al.', 'interventionNames': ['Other: Minimal Flow Anesthesia']}, {'type': 'OTHER', 'label': 'High Flow Anesthesia', 'description': 'High Flow Anesthesia (50% O2, 50% air), Desflurane (MAC = 4,5) In hypotensive anesthesia application; Remifentanil will be used at infusion rates of 0.025-0.1μg / kg / min after a loading dose of 1 μg / kg / min, with mean Arterial Pressure 55-65 mmHg.\n\nBefore the induction of anesthesia and 30 minutes of anesthesia, 2 ml of venous blood sample will be taken from the patients and simultaneous tissue oxygen saturation will be recorded. Serum thiol disulfide levels obtained from the blood sample of the recipient will be studied in the biochemistry research laboratory using the method developed by Erel et al.', 'interventionNames': ['Other: High Flow Anesthesia']}], 'interventions': [{'name': 'Minimal Flow Anesthesia', 'type': 'OTHER', 'description': 'Minimal Flow Anesthesia with 0,4 L min-1', 'armGroupLabels': ['Minimal Flow Anesthesia']}, {'name': 'High Flow Anesthesia', 'type': 'OTHER', 'description': 'High Flow Anesthesia with 2 L min-1', 'armGroupLabels': ['High Flow Anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53200', 'city': 'Rize', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Şule Batçık, Asst. Prof.', 'role': 'CONTACT'}], 'facility': 'Recep Tayyip Erdoğan University Training and Research Hospital', 'geoPoint': {'lat': 41.02083, 'lon': 40.52194}}], 'centralContacts': [{'name': 'Şule Batçık, Asst. Prof.', 'role': 'CONTACT', 'email': 'drsulebatcik@gmail.com', 'phone': '+904642130491', 'phoneExt': '2128'}, {'name': 'Leyla Kazancıoğlu, Asst. Prof.', 'role': 'CONTACT', 'email': 'leylahotaman@hotmail.com', 'phone': '+904642130491', 'phoneExt': '2128'}], 'overallOfficials': [{'name': 'Şule Batçık, Asst. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Recep Tayyip Erdoğan University Medical School Department of Anesthesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Recep Tayyip Erdogan University Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Şule Batçık', 'investigatorAffiliation': 'Recep Tayyip Erdogan University Training and Research Hospital'}}}}