Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT01158820
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2010-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Alternative Sedation During Bronchoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D004155', 'term': 'Diphenhydramine'}, {'id': 'D004319', 'term': 'Doxylamine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mandelj@uphs.upenn.edu', 'phone': '2156150553', 'title': 'Jeff E Mandel MD MS', 'organization': 'Department of Anesthesiology & Critical Care'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The presence of an anesthesiologist may have affected the aggressiveness of the pulmonologists in administering sedation.\n\nAlterations in the study drug were not permitted; an open label study might find larger differences in respiratory measures'}}, 'adverseEventsModule': {'timeFrame': 'The AE data was collected over a 2 year period from the enrollment date for each participant .', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo + Standard of Care (midazolam and fentanyl)', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexmedetomidine and Ketamine', 'description': 'dexmedetomidine and ketamine + Standard of Care (midazolam + fentanyl)', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Decreased Minute Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo + Standard of Care of midazolam and fentanyl'}, {'id': 'OG001', 'title': 'Dexmedetomidine and Ketamine', 'description': 'dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.736', 'groupId': 'OG000', 'lowerLimit': '0.592', 'upperLimit': '0.848'}, {'value': '0.764', 'groupId': 'OG001', 'lowerLimit': '0.592', 'upperLimit': '0.891'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.028', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'No data available for power analysis'}], 'paramType': 'MEDIAN', 'timeFrame': 'During the bronchoscopy procedure only, 58.5 minutes average', 'description': 'An initial baseline minute ventilation estimate was obtained via calibrated respiratory impedance plethysmography bands. Subsequent minute ventilation was normalized to this value. Values exceeding 100% were excluded from analysis, as these typically reflected a period of hyperpnea subsequent to relief of airway obstruction by chin lift or jaw thrust.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Fentanyl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo + Standard of Care of midazolam and fentanyl'}, {'id': 'OG001', 'title': 'Dexmedetomidine and Ketamine', 'description': 'dexmedetomidine and ketamine + Standard of Care (midazolam + fentanyl)'}], 'classes': [{'categories': [{'measurements': [{'value': '112.5', 'groupId': 'OG000', 'lowerLimit': '87.5', 'upperLimit': '188.4'}, {'value': '68.75', 'groupId': 'OG001', 'lowerLimit': '21.9', 'upperLimit': '103.1'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '43.75', 'estimateComment': 'units are µg', 'groupDescription': 'See reference power analysis', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'During the bronchoscopy procedure only, 58.5 minutes average', 'description': 'Total fentanyl dose delivered during the procedure', 'unitOfMeasure': 'µg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Midazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo + Standard of Care of midazolam and fentanyl'}, {'id': 'OG001', 'title': 'Dexmedetomidine and Ketamine', 'description': 'dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '7.5'}, {'value': '2.75', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '4.1'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.75', 'estimateComment': 'units are mg', 'groupDescription': 'See reference for power analysis', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of procedure', 'description': 'Total midazolam delivered during procedure', 'unitOfMeasure': 'mg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Desaturation (Cumulative)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo + Standard of Care of midazolam and fentanyl'}, {'id': 'OG001', 'title': 'Dexmedetomidine and Ketamine', 'description': 'dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '117.5'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '170.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the bronchoscopy procedure only, 58.5 minutes average', 'description': 'Cumulative time below saturation of 90% - the total number of seconds that the pulse oximeter reported a saturation below 90%', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Desaturation (Longest)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo + Standard of Care of midazolam and fentanyl'}, {'id': 'OG001', 'title': 'Dexmedetomidine and Ketamine', 'description': 'dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '43.5'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '53.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the bronchoscopy procedure only, 58.5 minutes average', 'description': 'Longest time below saturation of 90% (the number of seconds elapsed between the start of a period in which the pulse oximeter saturation fell below 90% and the return above 90%)', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Conversion to General Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo + Standard of Care of midazolam and fentanyl'}, {'id': 'OG001', 'title': 'Dexmedetomidine and Ketamine', 'description': 'dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the bronchoscopy procedure only, 58.5 minutes average', 'description': 'Patients in which the procedure could not be completed without conversion to general anesthesia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo + Standard of Care of midazolam and fentanyl'}, {'id': 'OG001', 'title': 'Dexmedetomidine and Ketamine', 'description': 'dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '10'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'After the bronchoscopy procedure only', 'description': 'Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Endoscopist Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo + Standard of Care of midazolam and fentanyl'}, {'id': 'OG001', 'title': 'Dexmedetomidine and Ketamine', 'description': 'dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '8.5'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '9.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'After the bronchoscopy procedure only', 'description': 'Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '1. Nebulized lidocaine 2% (maximum dose 200 mg) will be administered for 20 minutes.\n2. Following nebulization, syringe A (placebo) will be given at a rate of 1 µg/kg (based on a concentration of 4 µg/ml) for 10 minutes. Supplemental topical anesthesia will be administered by the pulmonologist during this time.\n3. After step 2, syringe B (midazolam 2 mg and fentanyl 50 µg) will be administered by the anesthesiologist. The infusion rate of syringe A (placebo) will be decreased to 0.7 µg/kg/hr. Syringe C (placebo) will be infused at 4 µg/kg/min (based on 10 mg/ml concentration)\n4. Boluses of 0.5 mg midazolam and 12.5 µg fentanyl will be administered by the pulmonologist from syringe D as needed for patient comfort. Syringe E (benadryl 25 mg) will be administered in entirety by the anesthesiologist after the 6th and 16th bolus of midazolam/fentanyl.\n\nplacebo + Standard of Care of midazolam and fentanyl: Control Saline 50 ml Midazolam 2 mg + Fentanyl 50 µg Saline 20 ml Midazolam 1'}, {'id': 'FG001', 'title': 'Dexmedetomidine and Ketamine', 'description': '1. Nebulized lidocaine 2% (maximum dose 200 mg) will be administered for 20 minutes.\n2. Following nebulization, syringe A (dexmedetomidine) will be given at a rate of 1 µg/kg (based on a concentration of 4 µg/ml) for 10 minutes. Supplemental topical anesthesia will be administered by the pulmonologist during this time.\n3. After step 2, syringe B (ketamine 30 mg) will be administered by the anesthesiologist. The infusion rate of syringe A (dexmedetomidine) will be decreased to 0.7 µg/kg/hr. Syringe C (ketamine) will be infused at 4 µg/kg/min (based on 10 mg/ml concentration)\n4. Boluses of 0.5 mg midazolam and 12.5 µg fentanyl will be administered by the pulmonologist from syringe D as needed for patient comfort. Syringe E (benadryl 25 mg) will be administered in entirety by the anesthesiologist after the 6th and 16th bolus of midazolam/fentanyl.\n\ndexmedetomidine and ketamine Study Medication: Experimental Dexmedetomidine 200 µg in 50 ml Ketamine 30 mg Ketamine 200 mg in 20 ml M'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited from the practices of the pulmonologist sub investigators by the principal investigator'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo + Standard of Care of midazolam and fentanyl'}, {'id': 'BG001', 'title': 'Dexmedetomidine and Ketamine', 'description': 'dexmedetomidine and ketamine + Standard of Care of midazolam and fentanyl'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', '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': '59.4', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '61.2', 'spread': '14.9', 'groupId': 'BG001'}, {'value': '59.88', 'spread': '15.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-05', 'studyFirstSubmitDate': '2010-06-25', 'resultsFirstSubmitDate': '2018-08-29', 'studyFirstSubmitQcDate': '2010-07-07', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-03', 'studyFirstPostDateStruct': {'date': '2010-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decreased Minute Ventilation', 'timeFrame': 'During the bronchoscopy procedure only, 58.5 minutes average', 'description': 'An initial baseline minute ventilation estimate was obtained via calibrated respiratory impedance plethysmography bands. Subsequent minute ventilation was normalized to this value. Values exceeding 100% were excluded from analysis, as these typically reflected a period of hyperpnea subsequent to relief of airway obstruction by chin lift or jaw thrust.'}, {'measure': 'Total Fentanyl', 'timeFrame': 'During the bronchoscopy procedure only, 58.5 minutes average', 'description': 'Total fentanyl dose delivered during the procedure'}, {'measure': 'Total Midazolam', 'timeFrame': 'Duration of procedure', 'description': 'Total midazolam delivered during procedure'}], 'secondaryOutcomes': [{'measure': 'Desaturation (Cumulative)', 'timeFrame': 'During the bronchoscopy procedure only, 58.5 minutes average', 'description': 'Cumulative time below saturation of 90% - the total number of seconds that the pulse oximeter reported a saturation below 90%'}, {'measure': 'Desaturation (Longest)', 'timeFrame': 'During the bronchoscopy procedure only, 58.5 minutes average', 'description': 'Longest time below saturation of 90% (the number of seconds elapsed between the start of a period in which the pulse oximeter saturation fell below 90% and the return above 90%)'}, {'measure': 'Conversion to General Anesthesia', 'timeFrame': 'During the bronchoscopy procedure only, 58.5 minutes average', 'description': 'Patients in which the procedure could not be completed without conversion to general anesthesia'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'After the bronchoscopy procedure only', 'description': 'Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)'}, {'measure': 'Endoscopist Satisfaction', 'timeFrame': 'After the bronchoscopy procedure only', 'description': 'Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bronchoscopy'], 'conditions': ['Sedation']}, 'referencesModule': {'references': [{'pmid': '23607840', 'type': 'RESULT', 'citation': 'Yarmus LB, Akulian JA, Gilbert C, Mathai SC, Sathiyamoorthy S, Sahetya S, Harris K, Gillespie C, Haas A, Feller-Kopman D, Sterman D, Lee HJ. Comparison of moderate versus deep sedation for endobronchial ultrasound transbronchial needle aspiration. Ann Am Thorac Soc. 2013 Apr;10(2):121-6. doi: 10.1513/AnnalsATS.201209-074OC.'}]}, 'descriptionModule': {'briefSummary': 'This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in less respiratory depression while providing better compliance with the procedure.', 'detailedDescription': 'All patients enrolled in the study will be undergoing bronchoscopy, which is typically performed with sedation. All procedural sedation carries some risk. Several features of the study may lower the risk of sedation relative to that of conventional sedation. An anesthesiologist will be present throughout the procedure. Continuous monitoring of respiration with RIP will be employed. Administration of sedation will be via a volumetric syringe pump. Benefits specific to dexmedetomidine-ketamine include the lack of respiratory depression and greater hemodynamic stability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over the age of 18 scheduled for elective flexible bronchoscopy in the endoscopy suite or OR of HUP\n\nExclusion Criteria:\n\n* History of inability to complete bronchoscopy attributable to inadequate sedation\n* Requiring more than 2 LPM supplemental oxygen to maintain SaO2 \\> 90%\n* History of allergy to study medications\n* Pregnancy\n* A history of psychosis\n* Any condition deemed likely by the pulmonologist or anesthesiologist to pose a significant risk due to elevation of blood pressure, including cerebral/aortic aneurysm, and or ischemic cardiovascular disease\n* Bradydysrhythmia deemed significant by the anesthesiologist or pulmonologist\n* A diagnosis of significant renal or hepatic impairment'}, 'identificationModule': {'nctId': 'NCT01158820', 'acronym': 'DEX', 'briefTitle': 'Alternative Sedation During Bronchoscopy', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'A Randomized, Placebo-controlled, Concealed Allocation Comparison of Respiratory Depression and Coughing During Bronchoscopy With Dexmedetomidine-ketamine as an Adjunct to Fentanyl-midazolam Sedation', 'orgStudyIdInfo': {'id': '810981'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand', 'interventionNames': ['Drug: Midazolam load', 'Drug: Fentanyl load', 'Drug: Midazolam demand', 'Drug: Fentanyl demand', 'Drug: Benadryl demand']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine and ketamine', 'description': 'dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand', 'interventionNames': ['Drug: Dexmedetomidine load', 'Drug: Ketamine load', 'Drug: Dexmedetomidine maintenance', 'Drug: Ketamine maintenance', 'Drug: Midazolam demand', 'Drug: Fentanyl demand', 'Drug: Benadryl demand']}], 'interventions': [{'name': 'Dexmedetomidine load', 'type': 'DRUG', 'otherNames': ['Precedex', 'Dexmedetomidine Hydrochloride'], 'description': 'Dexmedetomidine 1 µg/kg prior to bronchoscopy', 'armGroupLabels': ['dexmedetomidine and ketamine']}, {'name': 'Ketamine load', 'type': 'DRUG', 'otherNames': ['Ketalar', 'Calypsol', 'Ketamin', 'Ketaminol', 'Ketanest', 'Tekam', 'Vetalar'], 'description': 'Ketamine 30 mg bolus prior to bronchoscopy', 'armGroupLabels': ['dexmedetomidine and ketamine']}, {'name': 'Midazolam load', 'type': 'DRUG', 'otherNames': ['Versed'], 'description': '2 mg bolus prior to bronchoscopy', 'armGroupLabels': ['Placebo']}, {'name': 'Fentanyl load', 'type': 'DRUG', 'otherNames': ['Abstral', 'Actiq', 'Fentora', 'Onsolis'], 'description': '50 µg bolus prior to bronchoscopy', 'armGroupLabels': ['Placebo']}, {'name': 'Dexmedetomidine maintenance', 'type': 'DRUG', 'otherNames': ['Precedex', 'Dexmedetomidine Hydrochloride'], 'description': '0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average)', 'armGroupLabels': ['dexmedetomidine and ketamine']}, {'name': 'Ketamine maintenance', 'type': 'DRUG', 'otherNames': ['Ketalar', 'Calypsol', 'Ketamin', 'Ketaminol', 'Ketanest', 'Tekam', 'Vetalar'], 'description': '8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average)', 'armGroupLabels': ['dexmedetomidine and ketamine']}, {'name': 'Midazolam demand', 'type': 'DRUG', 'otherNames': ['Versed'], 'description': '0.5 mg demand bolus at discretion of pulmonologist', 'armGroupLabels': ['Placebo', 'dexmedetomidine and ketamine']}, {'name': 'Fentanyl demand', 'type': 'DRUG', 'otherNames': ['Abstral', 'Actiq', 'Fentora', 'Onsolis'], 'description': '12.5 µg demand bolus at discretion of pulmonologist', 'armGroupLabels': ['Placebo', 'dexmedetomidine and ketamine']}, {'name': 'Benadryl demand', 'type': 'DRUG', 'otherNames': ['Diphenhydramine Hcl', 'Aler-Dryl', 'Banophen', 'Ben Tann', 'Bromanate AF', 'Diphen', 'Diphenadryl', 'Diphenhist', 'Dytan', 'Unisom', 'Sominex', 'Silphen', 'Siladryl'], 'description': '25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus', 'armGroupLabels': ['Placebo', 'dexmedetomidine and ketamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jeff E Mandel, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospira, now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}