Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-01 @ 11:49 PM
Study NCT ID:
NCT04773002
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2021-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Volatile Anesthesia and Total Intravenous Anesthesia (TIVA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004438', 'term': 'Ecchymosis'}, {'id': 'D004487', 'term': 'Edema'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2021-02-23', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Edema and ecchymosis in rhinoplasty according to the type of anesthesia.', 'timeFrame': 'one time in six months', 'description': 'It is evaluation developing edema and ecchymosis according to total intravenous anesthesia and volatile anesthesia in rhinoplasty.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rhinoplasty', 'Ecchymosis', 'Edema', 'Hemorrhage']}, 'descriptionModule': {'briefSummary': 'In this study, investigators wanted to investigate the effect of volatile anesthesia and total intravenous anesthesia (TIVA) on ecchymosis, edema, and intraoperative bleeding in rhinoplasty.', 'detailedDescription': "Routine monitorization (blood pressure, pulse, oxygen saturation with pulse oximetry and electrocardiogram) will be applied to all patients taken into the operation room.\n\nIn Group P (TIVA), induction of anesthesia will be achieved with 2 mg/kg propofol, 0.6 mg/kg rocuronium, and 1 μ / kg fentanyl. Propofol and remifentanil will be used in the continuation of anesthesia.\n\nIn Group S (Volatile), anesthesia will be induced with 2 mg / kg propofol, 0.6 mg / kg rocuronium and 1 μ / kg fentanyl. 50% nitrous oxide + 50% oxygen and 2% sevoflurane will be used in the continuation of anesthesia.\n\nAll patients will receive 2 ml/kg/hour Ringer's lactate solution during the operation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Rhinoplasty patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 and 65 years\n* Planned to rhinoplasty\n* An American Society of Anesthesiologists score of 1 or 2\n\nExclusion Criteria:\n\n* Steroid use\n* Patients with coagulation disorders, •Rejected to participation'}, 'identificationModule': {'nctId': 'NCT04773002', 'briefTitle': 'A Comparison of Volatile Anesthesia and Total Intravenous Anesthesia (TIVA)', 'organization': {'class': 'OTHER', 'fullName': 'Tokat Gaziosmanpasa University'}, 'officialTitle': 'A Comparison of Volatile Anesthesia and Total Intravenous Anesthesia (TIVA) on Ecchymosis, Edema, and Intraoperative Bleeding in Rhinoplasty', 'orgStudyIdInfo': {'id': '21-KAEK-006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group P', 'description': 'Total intravenous anesthesia (TIVA)', 'interventionNames': ['Other: Different anesthesia methods']}, {'label': 'Group S', 'description': 'Volatile anestesia', 'interventionNames': ['Other: Different anesthesia methods']}], 'interventions': [{'name': 'Different anesthesia methods', 'type': 'OTHER', 'description': 'Total intravenous anesthesia (TIVA)and volatile anesthesia', 'armGroupLabels': ['Group P', 'Group S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60200', 'city': 'Tokat Province', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziosmanpasa University', 'geoPoint': {'lat': 40.31389, 'lon': 36.55444}}], 'overallOfficials': [{'name': 'Muzaffer Katar', 'role': 'STUDY_CHAIR', 'affiliation': 'Gaziosmanpasa university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokat Gaziosmanpasa University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Hakan Tapar', 'investigatorAffiliation': 'Tokat Gaziosmanpasa University'}}}}