Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-05 @ 5:30 PM
Study NCT ID:
NCT01905904
Status:
COMPLETED
Last Update Posted:
2019-05-16
First Post:
2013-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sevoflurane in Electroconvulsive Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-15', 'studyFirstSubmitDate': '2013-07-16', 'studyFirstSubmitQcDate': '2013-07-22', 'lastUpdatePostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure', 'timeFrame': 'taken prior to the seizure'}], 'secondaryOutcomes': [{'measure': 'sevoflurane used in electroconvulsive therapy (ECT) on hemodynamic response.', 'timeFrame': 'taken prior to the seizure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['electroconvulsive therapy', 'seizures', 'sevoflurane'], 'conditions': ['ECT', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to investigate the effects of different doses of sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and recovery profiles', 'detailedDescription': 'Motor (EMG) and electroencephalography seizure duration (EEG), heart rate (HR) and mean arterial pressure (MAP) values, and recovery times were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Study included 25 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who were scheduled for ECT sessions under general anesthesia\n\nExclusion Criteria:\n\n* Pregnancy\n* Cerebrovascular disease\n* Epilepsy\n* Unstable cardiovascular disease\n* Chronic obstructive pulmonary disease; and\n* Renal or hepatic failure'}, 'identificationModule': {'nctId': 'NCT01905904', 'briefTitle': 'Sevoflurane in Electroconvulsive Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'The Comparision of Different Doses of Sevoflurane for Induction of General Anesthesia in Electroconvulsive Therapy', 'orgStudyIdInfo': {'id': 'ulkü_2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'sevorane', 'description': 'Sevorane 4% concentration during anesthesia induction', 'interventionNames': ['Drug: sevorane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sevorane %7', 'description': 'Sevorane 7% concentration during anesthesia induction', 'interventionNames': ['Drug: sevorane']}], 'interventions': [{'name': 'sevorane', 'type': 'DRUG', 'otherNames': ['Sevoflurane'], 'description': 'Sevorane 4% Sevorane 7%', 'armGroupLabels': ['sevorane', 'sevorane %7']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44100', 'city': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Inonu Unıversity School of Medicine', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}], 'overallOfficials': [{'name': 'Huseyin Toprak, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inonu University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant profesor', 'investigatorFullName': 'Ülkü Özgül', 'investigatorAffiliation': 'Inonu University'}}}}