Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-29 @ 5:52 PM
Study NCT ID:
NCT01344759
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2011-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, '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': 'Mohamed.Mahmoud@cchmc.org', 'phone': '513-636-4408', 'title': 'Dr. Mohamed Mahmoud', 'organization': "Cincinnati Children's Hosptial Medical Center"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Failure to standardize mouth opening, due to stimulation of the subject during manipulation of the mouth No baseline measurements were obtained while awake Many patients had Downs syndrome so the results may not apply across all patients with OSA'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Propofol', 'description': 'Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cross Sectional Area of the Pharyngeal Airway', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol', 'description': '* Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump (Low dose). Baseline airway images are obtained during this time.\n* If a subject moves during baseline images a bolus of Propofol 0.5 mcg/kg will be given over 10 seconds and infusion rate will be increased to 120 mcg/kg/hr. If the subject moves a second time the research study will be terminated and patient will be under care of clinical team.\n* After the initial set of airway images are obtained, a bolus dose of propofol 2 mcg/kg will be given over 2 minutes followed by an increase in the infusion rate to 200 mcg/kg/hr (high dose).'}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': '* Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump (low dose). Baseline airway images are obtained during this time.\n* If a subject moves during baseline images a bolus of DEX 0.5 mcg/kg will be given over 3 minutes and infusion rate will be increased to 1.5 mcg/kg/hr. If the subject moves a second time the research study will be terminated and patient will be under care of clinical team.\n* After the initial set of airway images are obtained, a 2 mcg/kg bolus of DEX will be given over 10 minutes followed by an increase in the infusion rate to 3 mcg/kg/hr (high dose).'}], 'classes': [{'title': 'Low Dose Sedative, Nasopharyngeal measurement', 'categories': [{'measurements': [{'value': '239.9', 'groupId': 'OG000', 'lowerLimit': '185.4', 'upperLimit': '267.2'}, {'value': '178.5', 'groupId': 'OG001', 'lowerLimit': '148.5', 'upperLimit': '222.4'}]}]}, {'title': 'High Dose Sedative, Nasopharyngeal measurement', 'categories': [{'measurements': [{'value': '201.6', 'groupId': 'OG000', 'lowerLimit': '148.9', 'upperLimit': '291.7'}, {'value': '235.4', 'groupId': 'OG001', 'lowerLimit': '145.0', 'upperLimit': '258.8'}]}]}, {'title': 'Low Dose Sedative, Retroglossal measurement', 'categories': [{'measurements': [{'value': '115.1', 'groupId': 'OG000', 'lowerLimit': '67.8', 'upperLimit': '167.0'}, {'value': '120.9', 'groupId': 'OG001', 'lowerLimit': '63.6', 'upperLimit': '179.5'}]}]}, {'title': 'High dose sedative, Retroglossal measurement', 'categories': [{'measurements': [{'value': '108.1', 'groupId': 'OG000', 'lowerLimit': '53.6', 'upperLimit': '134.4'}, {'value': '120.5', 'groupId': 'OG001', 'lowerLimit': '50.1', 'upperLimit': '178.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'during MRI within first 10 minutes of scanning', 'description': 'The primary outcome measures will be the cross sectional area of the pharyngeal airway of the patients measured at two levels soft palate (nasopharyngeal) and base of the tongue (retroglossal). Magnetic resonance images of the airway were obtained during low (1 mcg/kg/hr) and high (3 mcg/kg/hr) doses of DEX or low (100 mcg/kg/m) and high (200 mcg/kg/m) doses of Propofol. All were administered through an intravenous (IV) catheter.', 'unitOfMeasure': 'mm^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Obstructive Index Until Recovery Room Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild OSA and Dexmedetomidine', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive DEX."}, {'id': 'OG001', 'title': 'Mild OSA and Propofol', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive Propofol."}, {'id': 'OG002', 'title': 'Moderate OSA and Dexmedetomidine', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive DEX."}, {'id': 'OG003', 'title': 'Moderate OSA and Propofol', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive Propofol."}, {'id': 'OG004', 'title': 'Severe OSA and Dexmedetomidine', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive DEX."}, {'id': 'OG005', 'title': 'Severe OSA and Propofol', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive Propofol."}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '4.9'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '3.5'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '7.4', 'upperLimit': '8.6'}, {'value': '8.0', 'groupId': 'OG003', 'lowerLimit': '5.9', 'upperLimit': '8.9'}, {'value': '16.7', 'groupId': 'OG004', 'lowerLimit': '14.1', 'upperLimit': '23.3'}, {'value': '17.1', 'groupId': 'OG005', 'lowerLimit': '14.6', 'upperLimit': '37.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During MRI and until recovery room discharge - approximately 30-250 minutes', 'description': 'The Obstructive Index is a count of the obstructive apnea events per hour of sleep', 'unitOfMeasure': 'Apnea events/hour of sleep', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Respiratory Disturbance Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild OSA and Dexmedetomidine', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive DEX."}, {'id': 'OG001', 'title': 'Mild OSA and Propofol', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive Propofol."}, {'id': 'OG002', 'title': 'Moderate OSA and Dexmedetomidine', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive DEX."}, {'id': 'OG003', 'title': 'Moderate OSA and Propofol', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive Propofol."}, {'id': 'OG004', 'title': 'Severe OSA and Dexmedetomidine', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive DEX."}, {'id': 'OG005', 'title': 'Severe OSA and Propofol', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive Propofol."}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '5.4'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '4.1'}, {'value': '8.8', 'groupId': 'OG002', 'lowerLimit': '7.7', 'upperLimit': '9.8'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '5.9', 'upperLimit': '9.1'}, {'value': '16.6', 'groupId': 'OG004', 'lowerLimit': '14.3', 'upperLimit': '19.6'}, {'value': '25.2', 'groupId': 'OG005', 'lowerLimit': '14.7', 'upperLimit': '41.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During MRI and until recovery room discharge - approximately 30-250 minutes', 'description': 'The respiratory disturbance index is a count of respiratory disturbance events per hour of sleep.', 'unitOfMeasure': 'respir.disturbance events/hr of sleep', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Needed Artificial Airway', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild OSA and Dexmedetomidine', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive DEX."}, {'id': 'OG001', 'title': 'Mild OSA and Propofol', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive Propofol."}, {'id': 'OG002', 'title': 'Moderate OSA and Dexmedetomidine', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive DEX."}, {'id': 'OG003', 'title': 'Moderate OSA and Propofol', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive Propofol."}, {'id': 'OG004', 'title': 'Severe OSA and Dexmedetomidine', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive DEX."}, {'id': 'OG005', 'title': 'Severe OSA and Propofol', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive Propofol."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During MRI and until recovery room discharge - approximately 30-250 minutes', 'description': 'This is the count of the number of patients who needed an artificial airway.', 'unitOfMeasure': 'Number of artifical airway events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Room Air SpO2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild OSA and Dexmedetomidine', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive DEX."}, {'id': 'OG001', 'title': 'Mild OSA and Propofol', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive Propofol."}, {'id': 'OG002', 'title': 'Moderate OSA and Dexmedetomidine', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive DEX."}, {'id': 'OG003', 'title': 'Moderate OSA and Propofol', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive Propofol."}, {'id': 'OG004', 'title': 'Severe OSA and Dexmedetomidine', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive DEX."}, {'id': 'OG005', 'title': 'Severe OSA and Propofol', 'description': "Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index \\>5-10, Severe=obstructive index\\>10)\n\nAdditionally this patient was assigned to receive Propofol."}], 'classes': [{'categories': [{'measurements': [{'value': '87.2', 'groupId': 'OG000', 'lowerLimit': '86.7', 'upperLimit': '87.7'}, {'value': '88.0', 'groupId': 'OG001', 'lowerLimit': '83.0', 'upperLimit': '91.0'}, {'value': '86.3', 'groupId': 'OG002', 'lowerLimit': '84.8', 'upperLimit': '87.5'}, {'value': '89.0', 'groupId': 'OG003', 'lowerLimit': '87.0', 'upperLimit': '93.0'}, {'value': '84.0', 'groupId': 'OG004', 'lowerLimit': '77.0', 'upperLimit': '88.8'}, {'value': '88.0', 'groupId': 'OG005', 'lowerLimit': '80.4', 'upperLimit': '88.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During MRI and until recovery room discharge - approximately 30-250 minutes', 'description': "The patient's oxygen saturation on room air.", 'unitOfMeasure': 'percentage of SpO2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Propofol', 'description': 'Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.'}, {'id': 'FG001', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'comment': 'Two of the original DEX group subjects were removed, due to receiving dexmedetomidine and propofol.', 'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Patients failed to reach sedation level', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Propofol', 'description': 'Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.'}, {'id': 'BG001', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'groupId': 'BG000', 'lowerLimit': '5.8', 'upperLimit': '14.3'}, {'value': '8.3', 'groupId': 'BG001', 'lowerLimit': '4.7', 'upperLimit': '16.1'}, {'value': '8.6', 'groupId': 'BG002', 'lowerLimit': '5.3', 'upperLimit': '15.2'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-06', 'studyFirstSubmitDate': '2011-04-21', 'resultsFirstSubmitDate': '2015-08-20', 'studyFirstSubmitQcDate': '2011-04-28', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-26', 'studyFirstPostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cross Sectional Area of the Pharyngeal Airway', 'timeFrame': 'during MRI within first 10 minutes of scanning', 'description': 'The primary outcome measures will be the cross sectional area of the pharyngeal airway of the patients measured at two levels soft palate (nasopharyngeal) and base of the tongue (retroglossal). Magnetic resonance images of the airway were obtained during low (1 mcg/kg/hr) and high (3 mcg/kg/hr) doses of DEX or low (100 mcg/kg/m) and high (200 mcg/kg/m) doses of Propofol. All were administered through an intravenous (IV) catheter.'}], 'secondaryOutcomes': [{'measure': 'Obstructive Index Until Recovery Room Discharge', 'timeFrame': 'During MRI and until recovery room discharge - approximately 30-250 minutes', 'description': 'The Obstructive Index is a count of the obstructive apnea events per hour of sleep'}, {'measure': 'Respiratory Disturbance Index', 'timeFrame': 'During MRI and until recovery room discharge - approximately 30-250 minutes', 'description': 'The respiratory disturbance index is a count of respiratory disturbance events per hour of sleep.'}, {'measure': 'Needed Artificial Airway', 'timeFrame': 'During MRI and until recovery room discharge - approximately 30-250 minutes', 'description': 'This is the count of the number of patients who needed an artificial airway.'}, {'measure': 'Room Air SpO2', 'timeFrame': 'During MRI and until recovery room discharge - approximately 30-250 minutes', 'description': "The patient's oxygen saturation on room air."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea', 'MRI', 'Pediatrics', 'Dexmedetomidine', 'Propofol', 'Anesthesia'], 'conditions': ['Sleep Apnea, Obstructive']}, 'referencesModule': {'references': [{'pmid': '16790626', 'type': 'BACKGROUND', 'citation': "Mason KP, Zgleszewski SE, Dearden JL, Dumont RS, Pirich MA, Stark CD, D'Angelo P, Macpherson S, Fontaine PJ, Connor L, Zurakowski D. Dexmedetomidine for pediatric sedation for computed tomography imaging studies. Anesth Analg. 2006 Jul;103(1):57-62, table of contents. doi: 10.1213/01.ane.0000216293.16613.15."}, {'pmid': '10910487', 'type': 'BACKGROUND', 'citation': 'Ebert TJ, Hall JE, Barney JA, Uhrich TD, Colinco MD. The effects of increasing plasma concentrations of dexmedetomidine in humans. Anesthesiology. 2000 Aug;93(2):382-94. doi: 10.1097/00000542-200008000-00016.'}, {'pmid': '12826844', 'type': 'BACKGROUND', 'citation': 'Talke P, Lobo E, Brown R. Systemically administered alpha2-agonist-induced peripheral vasoconstriction in humans. Anesthesiology. 2003 Jul;99(1):65-70. doi: 10.1097/00000542-200307000-00014.'}, {'pmid': '9356115', 'type': 'BACKGROUND', 'citation': 'Talke P, Richardson CA, Scheinin M, Fisher DM. Postoperative pharmacokinetics and sympatholytic effects of dexmedetomidine. 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Upper airway obstruction during midazolam/nitrous oxide sedation in children with enlarged tonsils. Pediatr Dent. 1998 Sep-Oct;20(5):318-20.'}, {'pmid': '11930064', 'type': 'BACKGROUND', 'citation': 'Donnelly LF, Casper KA, Chen B, Koch BL. Defining normal upper airway motion in asymptomatic children during sleep by means of cine MR techniques. Radiology. 2002 Apr;223(1):176-80. doi: 10.1148/radiol.2231011023.'}, {'pmid': '15208134', 'type': 'BACKGROUND', 'citation': 'Donnelly LF, Shott SR, LaRose CR, Chini BA, Amin RS. Causes of persistent obstructive sleep apnea despite previous tonsillectomy and adenoidectomy in children with down syndrome as depicted on static and dynamic cine MRI. AJR Am J Roentgenol. 2004 Jul;183(1):175-81. doi: 10.2214/ajr.183.1.1830175.'}, {'pmid': '14693585', 'type': 'BACKGROUND', 'citation': 'Ibacache ME, Munoz HR, Brandes V, Morales AL. Single-dose dexmedetomidine reduces agitation after sevoflurane anesthesia in children. 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No abstract available.'}, {'pmid': '16129969', 'type': 'BACKGROUND', 'citation': 'Eastwood PR, Platt PR, Shepherd K, Maddison K, Hillman DR. Collapsibility of the upper airway at different concentrations of propofol anesthesia. Anesthesiology. 2005 Sep;103(3):470-7. doi: 10.1097/00000542-200509000-00007.'}, {'pmid': '18363626', 'type': 'BACKGROUND', 'citation': 'Mason KP, Zurakowski D, Zgleszewski SE, Robson CD, Carrier M, Hickey PR, Dinardo JA. High dose dexmedetomidine as the sole sedative for pediatric MRI. Paediatr Anaesth. 2008 May;18(5):403-11. doi: 10.1111/j.1460-9592.2008.02468.x. Epub 2008 Mar 18.'}, {'pmid': '18363628', 'type': 'BACKGROUND', 'citation': 'Mason KP, Zgleszewski SE, Prescilla R, Fontaine PJ, Zurakowski D. Hemodynamic effects of dexmedetomidine sedation for CT imaging studies. Paediatr Anaesth. 2008 May;18(5):393-402. doi: 10.1111/j.1460-9592.2008.02451.x. 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Anesthesiology. 2002 Mar;96(3):607-11. doi: 10.1097/00000542-200203000-00016.'}, {'pmid': '8602656', 'type': 'BACKGROUND', 'citation': 'Mathru M, Esch O, Lang J, Herbert ME, Chaljub G, Goodacre B, vanSonnenberg E. Magnetic resonance imaging of the upper airway. Effects of propofol anesthesia and nasal continuous positive airway pressure in humans. Anesthesiology. 1996 Feb;84(2):273-9. doi: 10.1097/00000542-199602000-00004.'}, {'pmid': '7071350', 'type': 'BACKGROUND', 'citation': 'Thompson JR, Schneider S, Ashwal S, Holden BS, Hinshaw DB Jr, Hasso AN. The choice of sedation for computed tomography in children: a prospective evaluation. Radiology. 1982 May;143(2):475-9. doi: 10.1148/radiology.143.2.7071350.'}, {'pmid': '8765629', 'type': 'BACKGROUND', 'citation': 'Napoli KL, Ingall CG, Martin GR. Safety and efficacy of chloral hydrate sedation in children undergoing echocardiography. J Pediatr. 1996 Aug;129(2):287-91. doi: 10.1016/s0022-3476(96)70256-1.'}, {'pmid': '8352124', 'type': 'BACKGROUND', 'citation': 'Greenberg SB, Faerber EN, Aspinall CL, Adams RC. High-dose chloral hydrate sedation for children undergoing MR imaging: safety and efficacy in relation to age. AJR Am J Roentgenol. 1993 Sep;161(3):639-41. doi: 10.2214/ajr.161.3.8352124.'}, {'pmid': '7989402', 'type': 'BACKGROUND', 'citation': 'Ronchera-Oms CL, Casillas C, Marti-Bonmati L, Poyatos C, Tomas J, Sobejano A, Jimenez NV. Oral chloral hydrate provides effective and safe sedation in paediatric magnetic resonance imaging. J Clin Pharm Ther. 1994 Aug;19(4):239-43. doi: 10.1111/j.1365-2710.1994.tb00680.x.'}, {'pmid': '10702460', 'type': 'BACKGROUND', 'citation': 'Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and propofol, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults with a history of obstructive sleep apnea (OSA) having an MRI scan.\n\nThe results of this study will help in making the best decisions regarding the anesthesia medications that are most appropriate for children, adolescents, and young adults with OSA during MRI studies.', 'detailedDescription': 'Patients with OSA are at risk for airway obstruction (a condition that makes it difficult to breath) during sedation and anesthesia. Dexmedetomidine and propofol are safe and effective drugs regularly used by anesthesiologists. These drugs are used to put patients to sleep for operations and certain studies like MRI scans. However, there have been no studies describing the effects these drugs have on the upper airway of children, adolescents, and young adults with OSA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with documented history of OSA by polysomnography who require anesthesia for MRI sleep study or MRI brain imaging study.\n2. Subjects must be 12 months to 25 years of age (inclusive)\n3. Either the subject (if subject's age is 18-25) or the subject's legally authorized representative has given written informed consent to participate in the study\n\nExclusion Criteria:\n\n1. The subject has life-threatening medical conditions (American Society of Anesthesiologists Physical Status 4, 5 or 6). The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is. For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).\n2. The subject is allergic to or has a contraindication to propofol or dexmedetomidine.\n3. The subject has a tracheostomy or other mechanical airway device\n4. The subject is not scheduled to receive anesthesia-sedation care for the MRI\n5. The subject has a history or a family (parent or sibling) history of malignant hyperthermia."}, 'identificationModule': {'nctId': 'NCT01344759', 'briefTitle': 'Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Effect of Increasing Depth of Dexmedetomidine and Propofol Anesthesia on Upper Airway Morphology in Children With History of Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'CCHMC 2009-0514'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Diprivan'], 'description': 'Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.', 'armGroupLabels': ['Propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Mohamed Mahmoud, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}