Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-28 @ 8:03 AM
Study NCT ID:
NCT03361605
Status:
COMPLETED
Last Update Posted:
2020-08-18
First Post:
2017-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neuroimaging of Anesthetic Modulation of Human Consciousness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}}}}, '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': 'adrongo@med.umich.edu', 'phone': '734-647-8129', 'title': 'Amy McKinney', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Propofol Administration', 'description': 'Propofol: Propofol administration', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol Administration', 'description': 'Propofol: Propofol administration'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.349', 'spread': '0.223', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.349', 'pValueComment': 'The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.223', 'estimateComment': 'Difference = BOLD Response During Sedation - BOLD Response During Baseline', 'groupDescription': 'The null hypothesis is no difference in BOLD response between sedated state and baseline.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Our study adopted a within-subject design, which is not a randomized controlled trial (RCT) such as testing if one treatment is superior to another. Therefore, here the "Superiority" indicates if propofol administration has a statistically significant impact on the brain activity in response to sensory stimuli.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 minutes', 'description': 'Change = BOLD Response During Sedation - BOLD Response During Baseline', 'unitOfMeasure': 'percentage of BOLD signal change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to study brain activity change (BOLD response) during propofol administration'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Squeeze Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol Administration', 'description': 'Propofol: Propofol administration'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.16', 'spread': '3.09', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.00148', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-2.16', 'pValueComment': 'The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.09', 'estimateComment': 'Difference = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline', 'groupDescription': 'The null hypothesis is no difference in squeeze pressure between sedated state and baseline.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Our study adopted a within-subject design, which is not a randomized controlled trial (RCT) such as testing if one treatment is superior to another. Therefore, here the "Superiority" indicates if propofol administration has a statistically significant impact on the squeeze pressure in response to verbal instructions.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 minutes', 'description': "Measurements of the force of participants' hand squeezing on a rubber ball in response to instructions. Change = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline.", 'unitOfMeasure': 'Millimeter of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to study squeeze pressure change during propofol administration'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Propofol Administration', 'description': 'Propofol: Propofol administration'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Analyzable data not available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Propofol Administration', 'description': 'Propofol: Propofol administration'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BOLD response', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.599', 'spread': '0.244', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The BOLD (blood oxygen level-dependent) signal is the measured variable as obtained by functional magnetic resonance imaging (fMRI). It is an indirect, relative measure of local neuronal activity in the brain. Higher BOLD signal value indicates more neuronal activity.', 'unitOfMeasure': 'percentage of BOLD signal change', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Analyzable data was not available for four subjects'}, {'title': 'Squeeze pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13.98', 'spread': '5.27', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Analyzable data was not available for four subjects'}], 'populationDescription': '29 participants were consented and received study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-10', 'size': 351322, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-25T06:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-04', 'studyFirstSubmitDate': '2017-11-03', 'resultsFirstSubmitDate': '2020-06-25', 'studyFirstSubmitQcDate': '2017-11-28', 'lastUpdatePostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-27', 'studyFirstPostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation', 'timeFrame': 'Baseline to 90 minutes', 'description': 'Change = BOLD Response During Sedation - BOLD Response During Baseline'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Squeeze Pressure', 'timeFrame': 'Baseline to 90 minutes', 'description': "Measurements of the force of participants' hand squeezing on a rubber ball in response to instructions. Change = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study\'s purpose is to see if mental functions take place during different levels of anesthesia, using a commonly used drug (Propofol). fMRI (functional Magnetic Resonance Imaging, or "brain imaging") shows areas in the brain involved in thinking at different depths of anesthesia.', 'detailedDescription': 'Administering anesthetic drugs to suppress consciousness is an imperatively important step in major surgical operations. Yet the neurobiological mechanisms that underlie loss of consciousness under general anesthesia remain elusive. Despite advancements in understanding the molecular, synaptic, and cellular effects of anesthetics, the large-scale, systems-level modulation of neuronal processes that support conscious cognitive functions is incompletely understood. While profound decreases in global and regional brain metabolism, blood flow, and functional connectivity have been reported, these changes often fail to correlate with the loss and return of consciousness. To date, there is no "consciousness meter" or "gold standard" to objectively assess and monitor the level of consciousness under general anesthesia. Several studies suggest that residual cognitive functions may not completely vanish under general anesthesia; however, the level and complexity of residual information processing in the anesthetized brain remains unknown. Finally, the neurobiological mechanisms that govern anesthesia induction and emergence appear to be partially different, but the relevance of these differences to the modulation of the state of consciousness is unclear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must have a body mass index (BMI) less than 30.\n2. Must be right handed\n3. Must be English speaking\n4. Must be capable of giving written informed consent.\n5. Must have history of playing tennis (or any type of racquet sport) at least 30 times over lifetime.\n\nExclusion Criteria:\n\n1. History of obstructive sleep apnea;\n2. History of a difficult airway with a previous anesthetic;\n3. History of neurological disorders;\n4. Hypertension or other cardiovascular abnormalities;\n5. Pulmonary hypertension or other pulmonary abnormalities;\n6. Gastroesophageal reflux disease (GERD) or heartburn;\n7. History of significant head injury with loss of consciousness;\n8. Learning disability or other developmental disorder;\n9. Allergic reactions to eggs;\n10. Pregnant or nursing mothers;\n11. Contraindications to neuroimaging methods;\n12. Inability or unwilling to fast, or withhold food and liquid intake, for 8 hours prior to your scheduled study visit.\n13. Unwilling to abstain from alcohol use for 24 hours prior to your scheduled study visit.\n14. History of drug use, or have a positive drug screen.\n15. Tattoos on the head or neck region - all other tattoos are subject to determination by investigators.\n16. Any impairment, activity or situation that in the judgment of the study coordinator or Principal Investigators would prevent satisfactory completion of the study protocol.'}, 'identificationModule': {'nctId': 'NCT03361605', 'briefTitle': 'Neuroimaging of Anesthetic Modulation of Human Consciousness', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Neuroimaging of Anesthetic Modulation of Human Consciousness', 'orgStudyIdInfo': {'id': 'HUM00103361'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propofol Administration', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'Propofol administration', 'armGroupLabels': ['Propofol Administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Medicine - University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Anthony G Hudetz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Anthony G Hudetz', 'investigatorAffiliation': 'University of Michigan'}}}}