Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT01200433
Status:
COMPLETED
Last Update Posted:
2016-12-14
First Post:
2010-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Effects of Dexmedetomidine and Propofol on Cerebral Blood Flow and Brain Oxygenation During Deep Brain Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'farage@ccf.org', 'phone': '216-444-9950', 'title': 'Ehab Farag, MD', 'organization': 'Clevland Clinic Foundation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Propofol', 'description': "Subjects will be sedated with propofol.\n\npropofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response", 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexmedetomidine', 'description': 'Subjects will be sedated with dexmedetomidine.\n\ndexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cerebral Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol', 'description': "Subjects will be sedated with propofol.\n\npropofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response"}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'Subjects will be sedated with dexmedetomidine.\n\ndexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.4', 'groupId': 'OG000', 'lowerLimit': '37.0', 'upperLimit': '48.0'}, {'value': '39.9', 'groupId': 'OG001', 'lowerLimit': '31.5', 'upperLimit': '47.0'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.94', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.05', 'estimateComment': 'Dexmedetomidine vs. propofol', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'We tested a joint hypothesis that dexmedetomidine was noninferior to propofol both in terms of cerebral blood flow velocity and brain oxygenation during DBS surgery.\n\nA total of 44 patients provided a 90% power at the 0.05 significance level to detect noninferiority of dexmedetomidine to propofol using a noninferiority ratio of geometric means of 0.80, assuming a coefficient of variation of 25% for each of the 2 primary outcomes. Both outcomes were expected to follow a log-normal distribution.'}], 'paramType': 'MEDIAN', 'timeFrame': 'For patients randomized to dexmedetomidine: at the first peak of study drug (i.e., at peak dose of study drug during first infusion period); for patients randomized to propofol: when infusion of propofol stopped.', 'description': 'Cerebral blood flow was the average of right and left carotid velocities recorded by transcranial Doppler.', 'unitOfMeasure': 'cm/sec', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Brain Oxygen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol', 'description': "Subjects will be sedated with propofol.\n\npropofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response"}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'Subjects will be sedated with dexmedetomidine.\n\ndexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000', 'lowerLimit': '70.3', 'upperLimit': '76.6'}, {'value': '72.7', 'groupId': 'OG001', 'lowerLimit': '70.0', 'upperLimit': '75.3'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.99', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.02', 'estimateComment': 'Dexmedetomidine vs. propofol', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'We tested a joint hypothesis that dexmedetomidine was noninferior to propofol both in terms of cerebral blood flow velocity and brain oxygenation during DBS surgery.\n\nA total of 44 patients provided a 90% power at the 0.05 significance level to detect noninferiority of dexmedetomidine to propofol using a noninferiority ratio of geometric means of 0.80, assuming a coefficient of variation of 25% for each of the 2 primary outcomes. Both outcomes were expected to follow a log-normal distribution.'}], 'paramType': 'MEDIAN', 'timeFrame': 'during first (10-20 minutes) and second (throughout the procedure) study drug infusion periods', 'description': 'Brain oxygenation values were estimated by near-infrared spectroscopy and brain oxygenation was averaged across the first and second study drug infusion periods.', 'unitOfMeasure': '% oxygenation', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cerebral Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol', 'description': "Subjects will be sedated with propofol.\n\npropofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response"}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'Subjects will be sedated with dexmedetomidine.\n\ndexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '46.7', 'spread': '10.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after procedure, in post anesthesia care unit (PACU)', 'description': 'The investigator will test the hypothesis that dexmedetomidine is non-inferior to propofol for cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by near-infrared spectroscopy.', 'unitOfMeasure': 'cm/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The cerebral flow at PACU was not planned as a primary outcome. The primary outcome was cerebral flow at the first peak of study drug. The data was collect for information purpose only. No test was done for cerebral blood flow at PACU.'}, {'type': 'SECONDARY', 'title': 'Alertness/Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol', 'description': "Subjects will be sedated with propofol.\n\npropofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response"}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'Subjects will be sedated with dexmedetomidine.\n\ndexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '1', 'ciLowerLimit': '0', 'ciUpperLimit': '2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'at the first peak during DBS surgery', 'description': "Modified observer's assessment of alertness /sedation (OAA/S) scale which ranges from 0 to 5 (0 = does not respond to noxious stimuli and 5 = responds to name spoken in normal tone)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pulsatility Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol', 'description': "Subjects will be sedated with propofol.\n\npropofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response"}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'Subjects will be sedated with dexmedetomidine.\n\ndexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '1.05'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0.92', 'upperLimit': '1.15'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '1', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.18', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'at the first peak during DBS surgery', 'description': 'Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and minimum diastolic velocities divided by the mean velocity during the cardiac cycle.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cerebral Perfusion Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol', 'description': "Subjects will be sedated with propofol.\n\npropofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response"}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'Subjects will be sedated with dexmedetomidine.\n\ndexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000', 'lowerLimit': '45.1', 'upperLimit': '69.8'}, {'value': '54.6', 'groupId': 'OG001', 'lowerLimit': '48.9', 'upperLimit': '66.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at the first peak during DBS surgery', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Hypertensive Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol', 'description': "Subjects will be sedated with propofol.\n\npropofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response"}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'Subjects will be sedated with dexmedetomidine.\n\ndexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-1.9', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '0.2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'During DBS surgery', 'description': 'The number of hypertensive episodes during Deep Brain Stimulation (DBS) surgery.', 'unitOfMeasure': 'number of episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Apneic Episodes.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol', 'description': "Subjects will be sedated with propofol.\n\npropofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response"}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'Subjects will be sedated with dexmedetomidine.\n\ndexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '>0.99', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'during DBS surgery', 'description': 'The number of antihypertensive interventions during Deep Brain Stimulation (DBS) surgery.', 'unitOfMeasure': 'number of episodes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Propofol', 'description': "Subjects will be sedated with propofol.\n\npropofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response"}, {'id': 'FG001', 'title': 'Dexmedetomidine', 'description': 'Subjects will be sedated with dexmedetomidine.\n\ndexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Propofol', 'description': "Subjects will be sedated with propofol.\n\npropofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response"}, {'id': 'BG001', 'title': 'Dexmedetomidine', 'description': 'Subjects will be sedated with dexmedetomidine.\n\ndexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '65.4', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '64.5', 'spread': '8.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Others', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-31', 'studyFirstSubmitDate': '2010-09-10', 'resultsFirstSubmitDate': '2016-05-05', 'studyFirstSubmitQcDate': '2010-09-10', 'lastUpdatePostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-05', 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral Blood Flow', 'timeFrame': 'For patients randomized to dexmedetomidine: at the first peak of study drug (i.e., at peak dose of study drug during first infusion period); for patients randomized to propofol: when infusion of propofol stopped.', 'description': 'Cerebral blood flow was the average of right and left carotid velocities recorded by transcranial Doppler.'}, {'measure': 'Brain Oxygen', 'timeFrame': 'during first (10-20 minutes) and second (throughout the procedure) study drug infusion periods', 'description': 'Brain oxygenation values were estimated by near-infrared spectroscopy and brain oxygenation was averaged across the first and second study drug infusion periods.'}], 'secondaryOutcomes': [{'measure': 'Cerebral Blood Flow', 'timeFrame': 'after procedure, in post anesthesia care unit (PACU)', 'description': 'The investigator will test the hypothesis that dexmedetomidine is non-inferior to propofol for cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by near-infrared spectroscopy.'}, {'measure': 'Alertness/Sedation', 'timeFrame': 'at the first peak during DBS surgery', 'description': "Modified observer's assessment of alertness /sedation (OAA/S) scale which ranges from 0 to 5 (0 = does not respond to noxious stimuli and 5 = responds to name spoken in normal tone)"}, {'measure': 'Pulsatility Index', 'timeFrame': 'at the first peak during DBS surgery', 'description': 'Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and minimum diastolic velocities divided by the mean velocity during the cardiac cycle.'}, {'measure': 'Cerebral Perfusion Pressure', 'timeFrame': 'at the first peak during DBS surgery'}, {'measure': 'Number of Hypertensive Episodes', 'timeFrame': 'During DBS surgery', 'description': 'The number of hypertensive episodes during Deep Brain Stimulation (DBS) surgery.'}, {'measure': 'Number of Apneic Episodes.', 'timeFrame': 'during DBS surgery', 'description': 'The number of antihypertensive interventions during Deep Brain Stimulation (DBS) surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'propofol', 'cerebral blood flow', 'brain oxygenation'], 'conditions': ['Intracranial Neurosurgery']}, 'referencesModule': {'references': [{'pmid': '28891839', 'type': 'DERIVED', 'citation': 'Farag E, Kot M, Podolyak A, Argalious M, Deogaonkar M, Mascha EJ, Xu Z, Katzan I, Ebrahim Z. The relative effects of dexmedetomidine and propofol on cerebral blood flow velocity and regional brain oxygenation: A randomised noninferiority trial. Eur J Anaesthesiol. 2017 Nov;34(11):732-739. doi: 10.1097/EJA.0000000000000662.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will evaluate the effects of dexmedetomidine and propofol on cerebral blood flow and brain oxygenation during Deep Brain Stimulation (DBS) surgery. Specifically, the investigators will test the hypothesis that dexmedetomidine is non-inferior to propofol for cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by near-infrared spectroscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III.\n* Scheduled for DBS.\n\nExclusion Criteria:\n\n* History of dystonia.\n* Severe heart failure with ejection fraction less than 30%.\n* History of obstructive sleep apnea.\n* History of renal failure with creatinine level \\> 2 mg/dl.\n* Allergies to α-2 agonists and propofol.\n* Current use of α-2 agonist medications such as clonidine.'}, 'identificationModule': {'nctId': 'NCT01200433', 'briefTitle': 'The Effects of Dexmedetomidine and Propofol on Cerebral Blood Flow and Brain Oxygenation During Deep Brain Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'orgStudyIdInfo': {'id': '10-715'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'propofol', 'description': 'Subjects will be sedated with propofol.', 'interventionNames': ['Drug: propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine', 'description': 'Subjects will be sedated with dexmedetomidine.', 'interventionNames': ['Drug: dexmedetomidine']}], 'interventions': [{'name': 'dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.', 'armGroupLabels': ['dexmedetomidine']}, {'name': 'propofol', 'type': 'DRUG', 'description': "Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response", 'armGroupLabels': ['propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Ehab Farag, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ehab Farag', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}