Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-04 @ 2:34 PM
Study NCT ID:
NCT02150759
Status:
COMPLETED
Last Update Posted:
2019-04-29
First Post:
2014-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dexmedetomidine-ketamine in Femur Proximal Fracture Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tedy3333@naver.com', 'phone': '82-51-797-0421', 'title': 'Ki Hwa Lee', 'organization': 'Inje University, Haeundae paik hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 week', 'eventGroups': [{'id': 'EG000', 'title': 'Dexmedetomidine-Ketamine', 'description': 'Dexmedetomidine-Ketamine combination', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 21, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexmedetomidine-Fentanyl', 'description': 'Dexmedetomidine-Fentanyl combination', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 20, 'seriousNumAtRisk': 21, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'desaturation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'postoperative cardiopulmonary resuscitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Score Using Five Scales', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine-ketamine', 'description': 'Dexmedetomidine-ketamine group\n\nDexmedetomidine: dexmedetomidine infusion during spinal anesthesia\n\nKetamine: add dexmedetomidine during position change'}, {'id': 'OG001', 'title': 'Dexmedetomidine-fentanyl', 'description': 'Dexmedetomidine-fentanyl group\n\nDexmedetomidine: dexmedetomidine infusion during spinal anesthesia\n\nFentanyl: add dexmedetomidine during position change'}], 'classes': [{'title': 'Lateral position', 'categories': [{'title': '0', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '1', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '2', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hip flexion', 'categories': [{'title': '0', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '1', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': '3', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Spinal blodk', 'categories': [{'title': '0', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': '1', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': '2', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'average 10-20 minutes', 'description': 'We want to compare pain score (five scales; 0=calm, 1=facial grimacing, 2=moaning, 3=screaming, 4=restlessness or agitation, unable to proceed) when patients are lateral position during spinal anesthesia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Patient Positioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine-ketamine', 'description': 'Dexmedetomidine-ketamine group\n\nDexmedetomidine: dexmedetomidine infusion during spinal anesthesia\n\nKetamine: add dexmedetomidine during position change'}, {'id': 'OG001', 'title': 'Dexmedetomidine-fentanyl', 'description': 'Dexmedetomidine-fentanyl group\n\nDexmedetomidine: dexmedetomidine infusion during spinal anesthesia\n\nFentanyl: add dexmedetomidine during position change'}], 'classes': [{'title': 'Lateral position', 'categories': [{'title': '0', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': '1', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': '2', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': '3', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hip flexion', 'categories': [{'title': '0', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': '1', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': '2', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': '3', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Spinal block', 'categories': [{'title': '0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': '1', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': '2', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': '3', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'average 10-20 minutes during spinal anesthesia', 'description': 'We estimate quality of patient positioning (0=not satisfactory, 1=satisfactory, 2=good, 3=optimal) during spinal anesthesia between two groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dexmedetomidine-ketamine', 'description': 'Dexmedetomidine-ketamine group\n\nDexmedetomidine: dexmedetomidine infusion during spinal anesthesia\n\nKetamine: add dexmedetomidine during position change'}, {'id': 'FG001', 'title': 'Dexmedetomidine-fentanyl', 'description': 'Dexmedetomidine-fentanyl group\n\nDexmedetomidine: dexmedetomidine infusion during spinal anesthesia\n\nFentanyl: add dexmedetomidine during position change'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'from May 2014 to October 2016'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dexmedetomidine-Ketamine', 'description': 'Dexmedetomidine-Ketamine combination'}, {'id': 'BG001', 'title': 'Dexmedetomidine-Fentanyl', 'description': 'Dexmedetomidine-Fentanyl combination'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '78.28', 'spread': '6.47', 'groupId': 'BG000'}, {'value': '79.57', 'spread': '7.13', 'groupId': 'BG001'}, {'value': '78.90', 'spread': '6.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'weight', 'classes': [{'categories': [{'measurements': [{'value': '52.22', 'spread': '8.67', 'groupId': 'BG000'}, {'value': '55.79', 'spread': '8.15', 'groupId': 'BG001'}, {'value': '53.96', 'spread': '8.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-24', 'size': 256345, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-25T04:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-25', 'studyFirstSubmitDate': '2014-05-23', 'resultsFirstSubmitDate': '2018-08-19', 'studyFirstSubmitQcDate': '2014-05-27', 'lastUpdatePostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-25', 'studyFirstPostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score Using Five Scales', 'timeFrame': 'average 10-20 minutes', 'description': 'We want to compare pain score (five scales; 0=calm, 1=facial grimacing, 2=moaning, 3=screaming, 4=restlessness or agitation, unable to proceed) when patients are lateral position during spinal anesthesia.'}], 'secondaryOutcomes': [{'measure': 'Quality of Patient Positioning', 'timeFrame': 'average 10-20 minutes during spinal anesthesia', 'description': 'We estimate quality of patient positioning (0=not satisfactory, 1=satisfactory, 2=good, 3=optimal) during spinal anesthesia between two groups.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'Ketamine', 'Pain'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': '* Comparison study of analgesic effects for dexmedetomidine-fentanyl vs dexmedetomidine-ketamine\n* lateral position for spinal anesthesia in femur proximal fracture patients', 'detailedDescription': '* Dexmedetomidine (1mcg/kg)- fentanyl (1mcg/kg) vs dexmedetomidine (1mcg/kg) - ketamine (1mg/kg) 10 minutes loading.\n* After 10 minutes of drug infusion, patients are prepared for spinal anesthesia.\n* pain scale and quality of patient positioning are measured three times (lateral position, chest-knee position, intrathecal local anesthetics injection)\n* When patients have severe pain during intraoperative period, fentanyl 50 mcg will be intravenously inject.\n* Patients will be injected propofol 10mg when they have agitation signs during operation.\n* vital signs, bispectral index, korean version of mini mental status examination, verbal rating scale,fentany/propofol consumption, frequency of intrathecal injection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American society of anesthesiologists classification 1-3 patients\n* \\>20 years old\n\nExclusion Criteria:\n\n* patients refuse\n* dementia patients, cooperation difficult patients\n* anaphylaxis of dexmedetomidine, ketamine, local anesthetics\n* heart problem (bradycardia, atrioventricular block)'}, 'identificationModule': {'nctId': 'NCT02150759', 'briefTitle': 'Dexmedetomidine-ketamine in Femur Proximal Fracture Patients', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'Comparison Study of Analgesic Effects for Dexmedetomidine-fentanyl vs Dexmedetomidine-ketamine in Femur Proximal Fracture Patients', 'orgStudyIdInfo': {'id': '2014-027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine-ketamine', 'description': 'Dexmedetomidine-ketamine group', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Ketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine-fentanyl', 'description': 'Dexmedetomidine-fentanyl group', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Fentanyl']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'dexmedetomidine infusion during spinal anesthesia', 'armGroupLabels': ['Dexmedetomidine-fentanyl', 'Dexmedetomidine-ketamine']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['fentanyl citrate'], 'description': 'add dexmedetomidine during position change', 'armGroupLabels': ['Dexmedetomidine-fentanyl']}, {'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['ketamine HCl'], 'description': 'add dexmedetomidine during position change', 'armGroupLabels': ['Dexmedetomidine-ketamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '612-896', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Haeundae paik hospital, inje university', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'overallOfficials': [{'name': 'Sang Eun Lee, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Inje University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ki Hwa Lee', 'investigatorAffiliation': 'Inje University'}}}}