Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-27 @ 9:38 PM
Study NCT ID:
NCT02386995
Status:
COMPLETED
Last Update Posted:
2022-12-22
First Post:
2013-11-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BIS and Entropy in Deep Brain Simulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009069', 'term': 'Movement Disorders'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emad.alazazi@uhnresearch.ca', 'phone': '416-603-8500', 'title': 'Emad Al Azazi', 'phoneExt': '6237', 'organization': 'Toronto Western Hospital/UHN'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'one day', 'eventGroups': [{'id': 'EG000', 'title': 'BIS and Entropy Monitoring', 'description': 'Depth of anesthesia monitoring (BIS and entropy) are compared with standard clinical monitoring in patients with deep brain stimulators inserted at internalization whilst they are having a general anesthesia.\n\nBIS monitor: Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia monitoring are then compared.\n\nEntropy monitor: Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bispectral Index BIS', 'description': 'The trends of Bispectral index (BIS) at different study time points (T)'}, {'id': 'OG001', 'title': 'Response Entropy Index', 'description': 'The trends of Response Entropy index (RE) at different study time points (T)'}], 'classes': [{'title': 'T1 Awake (preinduction)', 'categories': [{'measurements': [{'value': '96', 'spread': '1', 'groupId': 'OG000'}, {'value': '96', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'T2 Loss of response to speech', 'categories': [{'measurements': [{'value': '65', 'spread': '4', 'groupId': 'OG000'}, {'value': '77', 'spread': '9', 'groupId': 'OG001'}]}]}, {'title': 'T3 Loss of eyelash reflex', 'categories': [{'measurements': [{'value': '59', 'spread': '5', 'groupId': 'OG000'}, {'value': '63', 'spread': '6', 'groupId': 'OG001'}]}]}, {'title': 'T4 Intubation', 'categories': [{'measurements': [{'value': '44', 'spread': '4', 'groupId': 'OG000'}, {'value': '53', 'spread': '5', 'groupId': 'OG001'}]}]}, {'title': 'T5 Knife to skin', 'categories': [{'measurements': [{'value': '44', 'spread': '2', 'groupId': 'OG000'}, {'value': '44', 'spread': '5', 'groupId': 'OG001'}]}]}, {'title': 'T6 Maintenance (prior to tunneling)', 'categories': [{'measurements': [{'value': '40', 'spread': '4', 'groupId': 'OG000'}, {'value': '33', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'T7 Tunneling in the neck', 'categories': [{'measurements': [{'value': '36', 'spread': '6', 'groupId': 'OG000'}, {'value': '32', 'spread': '5', 'groupId': 'OG001'}]}]}, {'title': 'T8 Start of skin closure', 'categories': [{'measurements': [{'value': '40', 'spread': '6', 'groupId': 'OG000'}, {'value': '37', 'spread': '6', 'groupId': 'OG001'}]}]}, {'title': 'T9 End of skin closure', 'categories': [{'measurements': [{'value': '42', 'spread': '8', 'groupId': 'OG000'}, {'value': '49', 'spread': '9', 'groupId': 'OG001'}]}]}, {'title': 'T10 Anaesthetic agent turned off', 'categories': [{'measurements': [{'value': '66', 'spread': '7', 'groupId': 'OG000'}, {'value': '59', 'spread': '6', 'groupId': 'OG001'}]}]}, {'title': 'T11 Obeying commands', 'categories': [{'measurements': [{'value': '87', 'spread': '3', 'groupId': 'OG000'}, {'value': '89', 'spread': '6', 'groupId': 'OG001'}]}]}, {'title': 'T12 Extubation', 'categories': [{'measurements': [{'value': '92', 'spread': '3', 'groupId': 'OG000'}, {'value': '93', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'T13 Post-extubation', 'categories': [{'measurements': [{'value': '93', 'spread': '3', 'groupId': 'OG000'}, {'value': '96', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One day', 'description': 'The trends of Bispectral (BIS) and Response entropy (RE) at different study time points.\n\nBispectral (BIS) and Response entropy (RE) values range from 0 (absence of brain activity) to 100 (fully awake state).\n\nValues below 40 indicate deep anesthesia, values from 40 to 60 optimal and above 60 but below 90 inadequate anesthesia.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Correlation analysis between BIS and RE from pre-induction time (T1) until the surgical closure time (T9) Bispectral (BIS) and Response entropy (RE) values range from 0 (absence of brain activity) to 100 (fully awake state).\n\nValues below 40 indicate deep anesthesia, values from 40 to 60 optimal and above 60 but below 90 inadequate anesthesia.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BIS and Entropy Monitoring', 'description': 'Depth of anesthesia monitoring (BIS and entropy) are compared with standard clinical monitoring in patients with deep brain stimulators inserted at internalization whilst they are having a general anesthesia.\n\nBIS monitor: Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia monitoring are then compared.\n\nEntropy monitor: Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'BIS and Entropy Monitoring', 'description': 'Depth of anesthesia monitoring (BIS and entropy) are compared with standard clinical monitoring in patients with deep brain stimulators inserted at internalization whilst they are having a general anesthesia.\n\nBIS monitor: Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia monitoring are then compared.\n\nEntropy monitor: Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '58.4', 'spread': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Demographic data values are presented as (mean±SD)'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-20', 'studyFirstSubmitDate': '2013-11-28', 'resultsFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2015-03-06', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-01', 'studyFirstPostDateStruct': {'date': '2015-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices', 'timeFrame': 'One day', 'description': 'The trends of Bispectral (BIS) and Response entropy (RE) at different study time points.\n\nBispectral (BIS) and Response entropy (RE) values range from 0 (absence of brain activity) to 100 (fully awake state).\n\nValues below 40 indicate deep anesthesia, values from 40 to 60 optimal and above 60 but below 90 inadequate anesthesia.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['depth of anesthesia monitors', 'deep brain stimulation'], 'conditions': ['Movement Disorders', 'Depth of Anesthesia Monitors']}, 'descriptionModule': {'briefSummary': "The main objective of the study is to determine whether depth of anesthesia (DOA) monitoring such as Bispectral Index (BIS) and entropy are accurate in patients with neuro-psychological conditions such as Parkinson's disease by comparing these monitoring with standard clinical monitoring like heart rate, blood pressure and respiratory rate.", 'detailedDescription': "Deep brain simulation (DBS) is an increasingly popular treatment for movement and psychiatric disorders such as Parkinson's disease and dystonia. These patients are quite sensitive to anesthetics and use of depth of anesthesia monitors are often needed to titrate the anesthetics. The calibration of BIS and entropy monitors has been done only on subjects with no neurological diseases. The investigators plan to record BIS and entropy readings during general anesthesia (GA) for the internalization of DBS electrodes. This would be useful as there are very few studies in this subset of patients with regards to DOA monitoring. Ashraf argued that the EEG may be altered under these circumstances and hence produce invalid BIS readings. Pemberton et al. studied patients undergoing tumour surgery using a sleep- awake-sleep anaesthesia technique. They found a poor correlation between BIS values and the observer's assessment of anesthesia level, suggesting that BIS is not a reliable tool for patients with brain abnormalities. The purpose of this study was to investigate whether BIS and entropy are helpful in titrating DOA in patients undergoing neurosurgical procedures or suffering from neurological diseases as they were frequently excluded from validation studies of the BIS monitoring device."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients having a general anesthesia post DBS insertion for the internalization of DBS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients older than 18 years of age scheduled for elective internalisation of DBS electrodes under general anesthesia.\n\nExclusion Criteria:\n\n* lack of informed consent\n* language barrier\n* those that are transferred to an intensive care unit postoperatively.'}, 'identificationModule': {'nctId': 'NCT02386995', 'briefTitle': 'BIS and Entropy in Deep Brain Simulation', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Comparison of Bispectral Index and Entropy Monitoring in Patients Undergoing Internalization of Deep Brain Simulation', 'orgStudyIdInfo': {'id': '13-6060'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BIS and Entropy monitoring', 'description': 'Depth of anesthesia monitoring (BIS and entropy) are compared with standard clinical monitoring in patients with deep brain stimulators inserted at internalization whilst they are having a general anesthesia.', 'interventionNames': ['Device: BIS monitor', 'Device: Entropy monitor']}], 'interventions': [{'name': 'BIS monitor', 'type': 'DEVICE', 'description': 'Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia monitoring are then compared.', 'armGroupLabels': ['BIS and Entropy monitoring']}, {'name': 'Entropy monitor', 'type': 'DEVICE', 'description': 'Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia', 'armGroupLabels': ['BIS and Entropy monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Heath Network, Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Lashmi Venkatraghavan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto Western Hospital'}, {'name': 'Pirjo Manninen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Heath Network, Toronto Western Hospital'}, {'name': 'Audrey MY Tan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Heath Network, Toronto Western Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Lashmi Venkatraghavan', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}