Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT05963256
Status:
UNKNOWN
Last Update Posted:
2023-08-01
First Post:
2023-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediction Model for TOF
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': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-27', 'studyFirstSubmitDate': '2023-07-19', 'studyFirstSubmitQcDate': '2023-07-19', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Train-of-four (TOF) ratio', 'timeFrame': '30 minutes after reaching the TOF plateau', 'description': 'The ratio of the height of the fourth muscle response to the first one following the nerve stimulation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurophysiologic Monitoring']}, 'descriptionModule': {'briefSummary': 'This study was aimed to investigate a prediction model for predicting train-of-four (TOF) 50% in patients undergoing neurosurgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient undergoing neurosurgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient undergoing neurosurgery\n* scheduled for intra-operative neurophysiological monitoring\n* American Society of Anesthesiologists physical class I, II, III\n\nExclusion Criteria:\n\n* unable to monitor train-of-four\n* decline to participate in the study'}, 'identificationModule': {'nctId': 'NCT05963256', 'briefTitle': 'Prediction Model for TOF', 'organization': {'class': 'OTHER', 'fullName': 'Kangbuk Samsung Hospital'}, 'officialTitle': 'Investigation for Development of Predictive Model for Train of Four (TOF)% for Neurophysiological Monitoring During Neuroanesthesia', 'orgStudyIdInfo': {'id': '2023-01-056'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Twitch Electrode Array', 'type': 'DEVICE', 'description': 'Monitor train-of-four (TOF) count and percentage'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03181', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Eunah Cho, PhD', 'role': 'CONTACT', 'email': 'mintflavored@naver.com', 'phone': '821094800531'}], 'facility': 'Eunah Cho', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Eunah Cho, PhD', 'role': 'CONTACT', 'email': 'mintflavored@naver.com', 'phone': '82-10-9480-0531'}], 'overallOfficials': [{'name': 'Eunah Cho, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KangbukSamsung Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunah Cho, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Eunah Cho, MD', 'investigatorAffiliation': 'Kangbuk Samsung Hospital'}}}}