Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-04-11 @ 10:56 PM
Study NCT ID:
NCT02925858
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2016-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Ketamine on Analgesia Post-Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'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': 'matthew.cameron@mcgill.ca', 'phone': '514-340-8222', 'title': 'Dr Matthew Cameron', 'phoneExt': '25701', 'organization': 'Jewish General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year, 6 months', 'description': 'No noted adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Ketamine', 'description': 'Intraoperative infusion of ketamine\n\nKetamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Control group receiving a saline infusion\n\nNormal Saline Flush, 0.9% Injectable Solution\\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quantity of Opioids Used in the First 48 Hours Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Intraoperative infusion of ketamine\n\nKetamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Control group receiving a saline infusion\n\nNormal Saline Flush, 0.9% Injectable Solution\\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight'}], 'classes': [{'categories': [{'measurements': [{'value': '10.71', 'groupId': 'OG000', 'lowerLimit': '9.41', 'upperLimit': '12.02'}, {'value': '11.14', 'groupId': 'OG001', 'lowerLimit': '9.68', 'upperLimit': '12.61'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First 48 hours after arrival to the ICU', 'description': 'Opioids used, in Dilaudid equivalents', 'unitOfMeasure': 'mg of Dilaudid', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quantity of Opioids Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Intraoperative infusion of ketamine\n\nKetamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Control group receiving a saline infusion\n\nNormal Saline Flush, 0.9% Injectable Solution\\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '5.75', 'upperLimit': '7.24'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '5.94', 'upperLimit': '7.45'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours postoperatively', 'description': 'Quantity in mg', 'unitOfMeasure': 'mg of Dilaudid', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Scores (Visual Analog Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Intraoperative infusion of ketamine\n\nKetamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Control group receiving a saline infusion\n\nNormal Saline Flush, 0.9% Injectable Solution\\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4.25'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Postoperative days 2', 'description': 'Average Pain Score as reported by the patient on a numeric scale ranging from 0 (no pain) to a maximum of 10 points (worst pain imaginable)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Nausea and Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Intraoperative infusion of ketamine\n\nKetamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Control group receiving a saline infusion\n\nNormal Saline Flush, 0.9% Injectable Solution\\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours after ICU arrival', 'description': 'Whether or not the patient suffered from nausea and vomiting after surgery which required treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intensive Care Unit Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Intraoperative infusion of ketamine\n\nKetamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Control group receiving a saline infusion\n\nNormal Saline Flush, 0.9% Injectable Solution\\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 day - 2 weeks', 'description': 'Number of days spent in the intensive care unit', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Intraoperative infusion of ketamine\n\nKetamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Control group receiving a saline infusion\n\nNormal Saline Flush, 0.9% Injectable Solution\\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '13'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 days - 2 weeks', 'description': 'number of days spent in the hospital, starting from the day of surgery', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Extubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Intraoperative infusion of ketamine\n\nKetamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Control group receiving a saline infusion\n\nNormal Saline Flush, 0.9% Injectable Solution\\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight'}], 'classes': [{'categories': [{'measurements': [{'value': '539', 'groupId': 'OG000', 'lowerLimit': '397', 'upperLimit': '682'}, {'value': '494', 'groupId': 'OG001', 'lowerLimit': '383', 'upperLimit': '605'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 hours - 2 weeks', 'description': 'Number of minutes from the time of ICU arrival to extubation', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Delirium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Intraoperative infusion of ketamine\n\nKetamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Control group receiving a saline infusion\n\nNormal Saline Flush, 0.9% Injectable Solution\\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'ICU stay', 'description': 'Delirium as assessed by a positive CAM-ICU score during the ICU stay', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Mobilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Intraoperative infusion of ketamine\n\nKetamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Control group receiving a saline infusion\n\nNormal Saline Flush, 0.9% Injectable Solution\\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '40'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '27'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During hospital stay', 'description': 'Time from ICU arrival until patient able to mobilize to chair, measured in hours', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Ambulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Intraoperative infusion of ketamine\n\nKetamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Control group receiving a saline infusion\n\nNormal Saline Flush, 0.9% Injectable Solution\\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '54', 'upperLimit': '76'}, {'value': '56', 'groupId': 'OG001', 'lowerLimit': '46', 'upperLimit': '64'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week postoperatively', 'description': 'Time from ICU arrival until patient able to ambulate, measured in hours', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Intraoperative infusion of ketamine\n\nKetamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)'}, {'id': 'FG001', 'title': 'Control', 'description': 'Control group receiving a saline infusion\n\nNormal Saline Flush, 0.9% Injectable Solution\\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketamine', 'description': 'Bolus 0.5mg/kg, Infusion 0.5mg/kg/hr'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Normal Saline 0.025cc/kg bolus, 0.025cc/kg/hr'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65.9', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '67.1', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '66.5', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (kg/m^2)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.0', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '28.0', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '28.5', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cardiopulmonary Bypass time (mins)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '105.4', 'spread': '33.7', 'groupId': 'BG000'}, {'value': '108.2', 'spread': '29.6', 'groupId': 'BG001'}, {'value': '106.7', 'spread': '31.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mins', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cross Clamp Time (mins)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '83.6', 'spread': '33.4', 'groupId': 'BG000'}, {'value': '82.7', 'spread': '25.6', 'groupId': 'BG001'}, {'value': '83.6', 'spread': '33.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Intraoperative Sufentanil per kg', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.17', 'spread': '1.11', 'groupId': 'BG000'}, {'value': '1.96', 'spread': '0.86', 'groupId': 'BG001'}, {'value': '2.07', 'spread': '1.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mcg/kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-23', 'size': 356681, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-18T12:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-06', 'studyFirstSubmitDate': '2016-10-04', 'resultsFirstSubmitDate': '2019-03-01', 'studyFirstSubmitQcDate': '2016-10-05', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-06', 'studyFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantity of Opioids Used in the First 48 Hours Postoperatively', 'timeFrame': 'First 48 hours after arrival to the ICU', 'description': 'Opioids used, in Dilaudid equivalents'}], 'secondaryOutcomes': [{'measure': 'Quantity of Opioids Used', 'timeFrame': '24 hours postoperatively', 'description': 'Quantity in mg'}, {'measure': 'Pain Scores (Visual Analog Scale)', 'timeFrame': 'Postoperative days 2', 'description': 'Average Pain Score as reported by the patient on a numeric scale ranging from 0 (no pain) to a maximum of 10 points (worst pain imaginable)'}, {'measure': 'Postoperative Nausea and Vomiting', 'timeFrame': '48 hours after ICU arrival', 'description': 'Whether or not the patient suffered from nausea and vomiting after surgery which required treatment'}, {'measure': 'Intensive Care Unit Length of Stay', 'timeFrame': '1 day - 2 weeks', 'description': 'Number of days spent in the intensive care unit'}, {'measure': 'Hospital Length of Stay', 'timeFrame': '5 days - 2 weeks', 'description': 'number of days spent in the hospital, starting from the day of surgery'}, {'measure': 'Time to Extubation', 'timeFrame': '4 hours - 2 weeks', 'description': 'Number of minutes from the time of ICU arrival to extubation'}, {'measure': 'Delirium', 'timeFrame': 'ICU stay', 'description': 'Delirium as assessed by a positive CAM-ICU score during the ICU stay'}, {'measure': 'Time to Mobilization', 'timeFrame': 'During hospital stay', 'description': 'Time from ICU arrival until patient able to mobilize to chair, measured in hours'}, {'measure': 'Time to Ambulation', 'timeFrame': '1 week postoperatively', 'description': 'Time from ICU arrival until patient able to ambulate, measured in hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketamine', 'Cardiac surgery', 'Pain'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative infusion of intravenous Ketamine on the quantity of opioid consumed postoperatively in coronary artery bypass surgery patients receiving a median sternotomy.', 'detailedDescription': 'This is a randomized, controlled, double-blind pilot study to determine the effectiveness of intraoperative Ketamine administration on pain after coronary artery bypass surgery. Patients will be randomized to receive ketamine or saline prior to incision, with a continuous infusion throughout surgery. Opioid dose administered in the first 48 hours will then be documented as the primary outcome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age or older coming for coronary artery bypass surgery with a left ventricular ejection fraction over 50% and able to consent prior to surgery\n\nExclusion Criteria:\n\n* Minimally invasive cardiac surgery\n* Preoperative opioid use\n* Preoperative hepatic or renal dysfunction'}, 'identificationModule': {'nctId': 'NCT02925858', 'briefTitle': 'Effect of Ketamine on Analgesia Post-Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Jewish General Hospital'}, 'officialTitle': 'Pilot Study: The Effect of Intraoperative Ketamine on Analgesia Post-Cardiac Surgery and Prevention of Chronic Pain', 'orgStudyIdInfo': {'id': '16-289'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Intraoperative infusion of ketamine', 'interventionNames': ['Drug: Ketamine Hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Control group receiving a saline infusion', 'interventionNames': ['Drug: Normal Saline Flush, 0.9% Injectable Solution_#1']}], 'interventions': [{'name': 'Normal Saline Flush, 0.9% Injectable Solution_#1', 'type': 'DRUG', 'description': 'Normal saline infusion mimicking infusion rate of ketamine for a given weight', 'armGroupLabels': ['Control']}, {'name': 'Ketamine Hydrochloride', 'type': 'DRUG', 'description': 'Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Matthew Cameron, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jewish General Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Upon request, starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'Will provide all uncoded data', 'accessCriteria': 'For planned meta-analyses'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jewish General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Matthew Cameron', 'investigatorAffiliation': 'Jewish General Hospital'}}}}