Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT04743193
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2021-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Different Low-flow Sevoflurane Anesthesia Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-27', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-02-05', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sevoflurane versus desflurane', 'timeFrame': 'the study will comlete in one month', 'description': 'To compare the instant and total consumption of sevoflurane using 2 different concentrations and different minute / fresh gas flow to fill the system in the initial phase of anesthesia.'}], 'secondaryOutcomes': [{'measure': 'sevoflurane', 'timeFrame': 'studdy will complete in one month', 'description': 'Its secondary purpose is to compare the depth of anesthesia and hemodynamic parameters between the two groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inhalation'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'After reaching 1 MAC level with 4 lt / min fresh gas flow and 2.5% sevoflurane concentration in the initial stage in 35 patients, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC. For 35 patients, after reaching 1 (MAC) level with 1 lt / min fresh gas flow and 8% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration, targeting 1 MAC.', 'detailedDescription': 'The primary aim of this study is to compare the instantaneous and total consumption of sevoflurane using 2 different concentrations and different minute / fresh gas flow to fill the system in the initial phase of anesthesia. Its secondary purpose is to compare the depth of anesthesia and hemodynamic parameters between the two groups.\n\nA total of 70 patients between the ages of 18-65 will be included in the study.in 2.5 % sevoflurane grup After reaching 1 MAC level with 4 lt / min fresh gas flow and 2.5% sevoflurane concentration in the initial stage in 35 patients, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC. in sevoflurane 8 % group for 35 patients, after reaching 1 (MAC) level with 1 lt / min fresh gas flow and 8% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC. . The depth of anesthesia for both groups will be measured by the Bispectral Index (BIS). BIS values between 40 and 60 are appropriate values for general anesthesia, for this value 1 MAC sevoflurane inhalation anesthesia and remifentanil infusion (0.1-0.3mcg / kg / min) will be used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Patients between the ages of 18-65\n* ASA1,2,3 group patients', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients between the ages of 18-65\n* ASA1,2,3 group patients\n* Patients under general anesthesia\n* Patients scheduled for elective surgery\n\nExclusion Criteria:\n\n* The patient's refusal to participate in the study\n* Patients with less than 90 minutes of total anesthesia time\n* Patients whose total anesthesia time exceeds 180 minutes"}, 'identificationModule': {'nctId': 'NCT04743193', 'briefTitle': 'Different Low-flow Sevoflurane Anesthesia Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli Derince Education and Research Hospital'}, 'officialTitle': 'Comparison of the Consumption of Sevoflurane in Two Different Concentrations and Two Different Currents During the Initial Period of Anesthesia in Patients Undergoing General Anesthesia With Minimal Flow', 'orgStudyIdInfo': {'id': '2020-514-169-13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'sevoflurane 8 %', 'description': 'In the initial phase, after reaching 1 (MAK) level with 1lt / min fresh gas flow and 8% sevoflurane concentration, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC.', 'interventionNames': ['Other: 8% sevoflurane low flow anesthesia']}, {'label': 'sevoflurane 2.5 %', 'description': 'In the initial phase, after reaching 1 MAK level with 4 lt / min fresh gas flow and 2.5% sevoflurane concentration, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC.', 'interventionNames': ['Other: 2.5 %sevoflurane']}], 'interventions': [{'name': '2.5 %sevoflurane', 'type': 'OTHER', 'description': 'for 35 patients after reaching 1 MAK level with 4 lt / min fresh gas flow and 2,5% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 minimum alveolar concentration', 'armGroupLabels': ['sevoflurane 2.5 %']}, {'name': '8% sevoflurane low flow anesthesia', 'type': 'OTHER', 'description': 'For 35 patients after reaching 1 (MAC) level with 1 lt / min fresh gas flow and 8% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration, targeting 1 MAC. .', 'armGroupLabels': ['sevoflurane 8 %']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'state': 'Kartal', 'country': 'Turkey (Türkiye)', 'facility': 'Tahsin Şimşek', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli Derince Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Tahsin Şimşek', 'investigatorAffiliation': 'Kocaeli Derince Education and Research Hospital'}}}}