Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT01543633
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2012-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'enb@neurostat.mit.edu', 'phone': '(617) 726-8786', 'title': 'Dr. Emery N. Brown', 'organization': 'Neuroscience Statistics Research Laboratory, Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': "24 hours. The day after completion of the anesthesia portion of the study, a follow-up call will be made by the study subject's dedicated anesthesiologist to ensure that the study subject has fully recovered and has no health concerns or problems related to the study.", 'description': 'The definition of adverse event and/or serious adverse event does not differ from the clinical trials.gov definitions.\n\nNote that the study was stopped if the blood pressure fell out of the range of 20% of the baseline values of end-tidal CO2, pulse oximetry levels, O2 saturation, and blood pressure. The study was also aborted if there is a problem with the placement of the intra-arterial or intravenous catheter.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Study Arm', 'description': 'Subjects recruited into this study will be required to undergo a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli.\n\nPropofol: Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press).', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'EEG Power in Alpha, Slow, and Delta Bands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Study Arm', 'description': 'Subjects recruited into this study will be required to undergo a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli.\n\nPropofol: Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press).'}], 'classes': [{'title': 'Alpha Band Power', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '12'}]}]}, {'title': 'Slow Band Power', 'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1'}]}]}, {'title': 'Delta Band Power', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '11 hours', 'description': 'We used EEG measurements to study the dynamics of loss of consciousness, auditory processing, sensation, and memory under general anesthesia induced with propofol. The EEG data in each of the three specific aims will be analyzed using spectral methods, source localization, and event-related potentials. Through spectral analysis, EEG power (in decibels) in alpha, slow, and delta bands are measured.', 'unitOfMeasure': 'Power of alpha band (decibels)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Study Arm', 'description': 'Subjects recruited into this study will be required to undergo a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli.\n\nPropofol: Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}]}], 'preAssignmentDetails': 'Subjects with abnormal cardiological abnormality, failure of the hearing test, abnormal ECG reading, and other medical conditions were excluded. Ten subjects also voluntarily withdrawn consent due to scheduling conflicts.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Study Arm', 'description': 'Subjects recruited into this study will be required to undergo a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli.\n\nPropofol: Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-30', 'size': 287216, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-07T08:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-13', 'studyFirstSubmitDate': '2012-02-16', 'resultsFirstSubmitDate': '2021-09-29', 'studyFirstSubmitQcDate': '2012-03-02', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-13', 'studyFirstPostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EEG Power in Alpha, Slow, and Delta Bands', 'timeFrame': '11 hours', 'description': 'We used EEG measurements to study the dynamics of loss of consciousness, auditory processing, sensation, and memory under general anesthesia induced with propofol. The EEG data in each of the three specific aims will be analyzed using spectral methods, source localization, and event-related potentials. Through spectral analysis, EEG power (in decibels) in alpha, slow, and delta bands are measured.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Brain Activity Under Sedation']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate how the commonly used anesthetic drug propofol works in the brain to produce loss of consciousness. While under general anesthesia your brain waves will be measured using electroencephalogram (EEG). On a separate day, the patient's brain will be imaged using magnetic resonance imaging (MRI)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, non-smoking male and female volunteers, ages 18-36 with normal body weight.\n* American Society of Anesthesiologists (ASA) physical status I\n\nExclusion Criteria:\n\n* History of head trauma\n* Surgical aneurysm clips\n* Cardiac pacemaker\n* Prosthetic heart valve\n* Neurostimulator\n* Implanted pumps\n* Cochlear implants\n* Metal rods, plates\n* Screws\n* Intrauterine device\n* Hearing aid\n* Dentures (which might create NMR artifacts)\n* Metal injury to eyes'}, 'identificationModule': {'nctId': 'NCT01543633', 'briefTitle': 'EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Electroencephalogram Studies of Induction and Recovery From Propofol Induced General Anesthesia', 'orgStudyIdInfo': {'id': '2005P001549'}, 'secondaryIdInfos': [{'id': '5DP1OD003646', 'link': 'https://reporter.nih.gov/quickSearch/5DP1OD003646', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Study Arm', 'description': 'Subjects recruited into this study will be required to undergo a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli.', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press).', 'armGroupLabels': ['Active Study Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Emery N Brown, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Emery N. Brown, M.D., Ph.D.', 'investigatorFullName': 'Emery Brown', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}