Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-01-17 @ 6:42 PM
Study NCT ID:
NCT02550795
Status:
COMPLETED
Last Update Posted:
2020-08-24
First Post:
2015-08-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'endless37@gilhospital.com', 'phone': '82324603636', 'title': 'Dr. Youn Yi Jo', 'organization': 'Gil hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'administration of 0.9% normal saline 10ml\n\nControl: administration of normal saline', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexmedetomidine', 'description': 'administration of 0.5ug/kg of dexmedetomidine (5ml)\n\nDexmedetomidine: administration of dexmedetomidine only', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dexmedetomidine and Dexamethasone', 'description': 'administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)\n\nDexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postoperative Nausea (Numeric Rating Scale for Nausea)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'administration of 0.9% normal saline 10ml\n\nControl: administration of normal saline'}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'administration of 0.5ug/kg of dexmedetomidine (5ml)\n\nDexmedetomidine: administration of dexmedetomidine only'}, {'id': 'OG002', 'title': 'Dexmedetomidine and Dexamethasone', 'description': 'administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)\n\nDexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.25'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Changes from baseline in postoperative nausea at 30 min', 'description': 'Numeric rating scale for postoperative nausea (scores on a scale) (0-no symptoms; 10-worst symptoms imaginable). Ramosetron 0.3 mg was administered to patients with nausea \\>5 points on the numeric rating scale', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who underwent breast cancer surgery'}, {'type': 'SECONDARY', 'title': 'Postoperative Vomiting (Number of Participants With Vomiting)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'administration of 0.9% normal saline 10ml\n\nControl: administration of normal saline'}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'administration of 0.5ug/kg of dexmedetomidine (5ml)\n\nDexmedetomidine: administration of dexmedetomidine only'}, {'id': 'OG002', 'title': 'Dexmedetomidine and Dexamethasone', 'description': 'administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)\n\nDexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone'}], 'classes': [{'title': '0-1 hour', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '1-6 hour', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '6-24hour', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Changes from baseline in postoperative nausea at 30 min', 'description': 'frequencies of vomiting (number of participants with vomiting) 24 hour post-operatively', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who underwent breast cancer surgery'}, {'type': 'SECONDARY', 'title': 'Rhodes Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'administration of 0.9% normal saline 10ml\n\nControl: administration of normal saline'}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'administration of 0.5ug/kg of dexmedetomidine (5ml)\n\nDexmedetomidine: administration of dexmedetomidine only'}, {'id': 'OG002', 'title': 'Dexmedetomidine and Dexamethasone', 'description': 'administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)\n\nDexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone'}], 'classes': [{'title': '1-6 hour after surgery', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5.5'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0.5'}]}]}, {'title': '6-24 hour after surgery', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '13'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3.5'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'assessed at 6 and 24 hour after operative end', 'description': 'Rhodes Index of nausea, vomiting, and retching at 6 to 24 hours after surgery (ask 8 question about discomfort due to PONV and each questions are consist of 0\\~4 score) (minimal PONV 0 to maximal PONV 32) lower values represent a bettwer outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'administration of 0.9% normal saline 10ml\n\nControl: administration of normal saline'}, {'id': 'FG001', 'title': 'Dexmedetomidine', 'description': 'administration of 0.5ug/kg of dexmedetomidine (5ml)\n\nDexmedetomidine: administration of dexmedetomidine only'}, {'id': 'FG002', 'title': 'Dexmedetomidine and Dexamethasone', 'description': 'administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)\n\nDexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'There was no one who excluded before assignment to groups'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'administration of 0.9% normal saline 10ml\n\nControl: administration of normal saline'}, {'id': 'BG001', 'title': 'Dexmedetomidine', 'description': 'administration of 0.5ug/kg of dexmedetomidine (5ml)\n\nDexmedetomidine: administration of dexmedetomidine only'}, {'id': 'BG002', 'title': 'Dexmedetomidine and Dexamethasone', 'description': 'administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)\n\nDexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '48.7', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '48.2', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '48.4', 'spread': '7.5', 'groupId': 'BG002'}, {'value': '48.5', 'spread': '7.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'one patient excluded from the analysis according to changes of surgery method'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2015-08-30', 'resultsFirstSubmitDate': '2019-02-14', 'studyFirstSubmitQcDate': '2015-09-14', 'lastUpdatePostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-11', 'studyFirstPostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Nausea (Numeric Rating Scale for Nausea)', 'timeFrame': 'Changes from baseline in postoperative nausea at 30 min', 'description': 'Numeric rating scale for postoperative nausea (scores on a scale) (0-no symptoms; 10-worst symptoms imaginable). Ramosetron 0.3 mg was administered to patients with nausea \\>5 points on the numeric rating scale'}], 'secondaryOutcomes': [{'measure': 'Postoperative Vomiting (Number of Participants With Vomiting)', 'timeFrame': 'Changes from baseline in postoperative nausea at 30 min', 'description': 'frequencies of vomiting (number of participants with vomiting) 24 hour post-operatively'}, {'measure': 'Rhodes Index Score', 'timeFrame': 'assessed at 6 and 24 hour after operative end', 'description': 'Rhodes Index of nausea, vomiting, and retching at 6 to 24 hours after surgery (ask 8 question about discomfort due to PONV and each questions are consist of 0\\~4 score) (minimal PONV 0 to maximal PONV 32) lower values represent a bettwer outcome'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postoperative Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'Previous reports demonstrated that dexmedetomidine could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.', 'detailedDescription': 'Previous reports demonstrated that dexmedetomidine, a alpha 2 selective agonist could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy.\n\nExclusion Criteria:\n\n* uncontrolled cardiovascular disease\n* history of chronic pain\n* smoker\n* previous history of steroid administraion\n* neoajuvant chemotherapy'}, 'identificationModule': {'nctId': 'NCT02550795', 'briefTitle': 'Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'Effects of Single Dose Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer', 'orgStudyIdInfo': {'id': 'Breast PONV'}, 'secondaryIdInfos': [{'id': 'GCIRB2014', 'type': 'REGISTRY', 'domain': 'GCIRB2014-154'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'administration of 0.9% normal saline 10ml', 'interventionNames': ['Drug: Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'description': 'administration of 0.5ug/kg of dexmedetomidine (5ml)', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine and dexamethasone', 'description': 'administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)', 'interventionNames': ['Drug: Dexmedetomidine and dexamethasone']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['DO'], 'description': 'administration of dexmedetomidine only', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'Dexmedetomidine and dexamethasone', 'type': 'DRUG', 'otherNames': ['DD'], 'description': 'administration of dexmedetomidine and dexamethasone', 'armGroupLabels': ['Dexmedetomidine and dexamethasone']}, {'name': 'Control', 'type': 'DRUG', 'otherNames': ['OO'], 'description': 'administration of normal saline', 'armGroupLabels': ['Control']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Youn Yi Jo', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}