Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-30 @ 5:45 PM
Study NCT ID:
NCT04431557
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2020-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Electroencephalogram Analysis in the Differences Between Inhalation Anesthetic and Propofol.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 268}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-11', 'studyFirstSubmitDate': '2020-06-09', 'studyFirstSubmitQcDate': '2020-06-11', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The gamma, beta, alpha and theta power of EEG', 'timeFrame': 'the total duration inclusions in operation room', 'description': 'We will try to observe the differences between hypnotic medications through EEG decomposed and power analysis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sevoflurane', 'Propofol']}, 'descriptionModule': {'briefSummary': 'The investigators will record 120 patients who received general anesthesia, their EEG data recorded from Bispectral Index (BIS) machine for emperical mode decomposition (EMD) analysis, the investigators decomposed EEG signal to different oscillations and tried to observe the differences between hypnotic medications through EEG analysis.', 'detailedDescription': 'The electroencephalography (EEG) is a noninvasive medical technique for monitoring and recording the electrical activity of brain. The Hilbert-Huang transform (HHT) was proposed to decompose EEG signal into intrinsic mode functions (IMF) which can obtain instantaneous frequency data and work well for data that is nonstationary and nonlinear.\n\nThe relationship between frontal EEG patterns and hypnotics remain poorly understood. The investigators only can tell the increase in frontal EEG power and shift power to lower frequencies during general anesthesia from publications. The investigators are going to decompose EEG with HHT and find the energy shift during general anesthesia, compare with different anesthetics.\n\nThe investigators will record 120 patients who received general anesthesia, their EEG data recorded from BIS machine for EMD analysis, the investigators decomposed EEG signal to different oscillations and tried to observe the differences between hypnotic medications through EEG analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population was focus on the patients who need schedule general anesthesia with low anesthesia risk (ASA I-II).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n* scheduled surgery who need general anesthesia\n\nExclusion Criteria:\n\n* allergy to the BIS patch\n* not suitable for general anesthesia'}, 'identificationModule': {'nctId': 'NCT04431557', 'briefTitle': 'The Electroencephalogram Analysis in the Differences Between Inhalation Anesthetic and Propofol.', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Electroencephalogram Analysis in the Differences Between Inhalation Anesthetic and Propofol.', 'orgStudyIdInfo': {'id': '201509018RINB'}}, 'contactsLocationsModule': {'locations': [{'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Feng-Fang Tsai, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}