Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-30 @ 3:29 PM
Study NCT ID:
NCT07040735
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-Flow Anesthesia and Open-Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-06', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'physiological parameter ; heart rate', 'timeFrame': 'Intraoperatively', 'description': 'Heart rate will be recorded every 10 minutes, expressed as beats per minute, starting before induction and including the sternotomy and pericardiotomy periods.'}, {'measure': 'physiological parameter; systolic/diastolic blood pressure', 'timeFrame': 'Intraoperatively', 'description': 'Systolic and diastolic blood pressure will be recorded every 10 minutes in mmHg, starting before induction and including the sternotomy and pericardiotomy periods.'}, {'measure': 'physiological parameter; SpO2', 'timeFrame': 'Intraoperatively', 'description': 'SpO2 will be recorded as a percentage every 10 minutes, starting before induction and including the sternotomy and pericardiotomy periods.'}, {'measure': 'Monitoring parameter; Bispectral Index (BIS)', 'timeFrame': 'Intraoperatively', 'description': 'The BIS value will be recorded numerically every 10 minutes, starting from before induction and including the sternotomy and pericardiotomy periods.'}, {'measure': 'Monitoring parameter; Minimum alveolar concentration (MAC)', 'timeFrame': 'Intraoperatively', 'description': 'The MAC value will be recorded numerically every 10 minutes, starting from before induction and including the sternotomy and pericardiotomy periods.'}], 'secondaryOutcomes': [{'measure': 'Preoperative data; ASA classification', 'timeFrame': '24 hours before surgery', 'description': "During the preoperative period, the patient's ASA classification will be recorded as I, II, III, IV."}, {'measure': 'Preoperative data', 'timeFrame': '24 hours before surgery', 'description': 'In the preoperative period, the degree of valve dysfunction (such as I.degree TY, II.degree MY) of the patients will be recorded.'}, {'measure': 'Preoperaitive data', 'timeFrame': '24 hours before surgery', 'description': "In the preoperative period, the patient's ejection fraction will be recorded as a percentage."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low-flow anesthesia', 'Hemodynamics', 'Open-heart surgery'], 'conditions': ['Low-flow Anesthesia', 'Hemodynamics', 'Open-heart Surgery']}, 'descriptionModule': {'briefSummary': 'Low-flow anesthesia (LFA) is a technique in which at least 50% of the exhaled air, after carbon dioxide absorption, is mixed with a certain amount of fresh gas and returned to the patient during the next inspiration. In 1974, R. Virtue defined minimal flow anesthesia (MFA) as 0.5 L/min. In 1984, Baker and Simionescu classified LFA as 0.5-1 L/min and MFA as 0.25-0.5 L/min. The aim of this study is to investigate whether there are hemodynamic differences between open-heart surgery cases performed with LFA at different fresh gas flow rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '≥18 years and scheduled for open-heart surgery patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-≥18 years and scheduled for open-heart surgery patients\n\n-ASA I-II-III-IV physical class\n\nExclusion Criteria:\n\n* Emergency cases\n* Patients under 18 years of age\n* Patients who have had open heart surgery before\n* Patients for whom the use of inhaled anesthetic agents is contraindicated\n* Patients who do not sign a voluntary consent form'}, 'identificationModule': {'nctId': 'NCT07040735', 'briefTitle': 'Low-Flow Anesthesia and Open-Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'The Effect of Low-Flow Anesthesia on Hemodynamics in Open-Heart Surgery', 'orgStudyIdInfo': {'id': '2025-146'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Followed using Bispectral Index (BIS) with 4% Sevoflurane and fresh gas flow set at 0.5 L/min'}, {'label': 'Group 2', 'description': 'Followed using Minimum Alveolar Concentration (MAC) with 4% Sevoflurane and fresh gas flow set at 0.5 L/min'}, {'label': 'Group 3', 'description': 'Followed using BIS with 4% Sevoflurane and fresh gas flow set at 1 L/min'}, {'label': 'Group 4', 'description': 'Followed using MAC with 4% Sevoflurane and fresh gas flow set at 1 L/min'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University Faculty of Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Çağrı Özdemir', 'role': 'CONTACT', 'email': 'cagriozdemir@gazi.edu.tr', 'phone': '+905544239196'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Çağrı Özdemir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'asst. prof.', 'investigatorFullName': 'Çağrı Özdemir', 'investigatorAffiliation': 'Gazi University'}}}}