Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-04-23 @ 6:59 PM
Study NCT ID:
NCT02452060
Status:
COMPLETED
Last Update Posted:
2020-03-16
First Post:
2015-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study on the Use of Low Dose Ketamine After Gastric Bypass and Gastrectomy
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': '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': 'jing.wang@nyulangone.org', 'phone': '212-460-0176', 'title': 'Jing Wang', 'organization': 'NYU Langone Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 Year', 'description': '0', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment/Placebo', 'description': 'saline infusion\n\nPlacebo Comparator: 0.4mg/kg infusion', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 9, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment', 'description': 'ketamine (0.4mg/kg)\n\nKetamine: 0.4mg/kg infusion', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 7, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'dizziness/lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'euphoria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'visual hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphoria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment/Placebo', 'description': 'saline infusion\n\nPlacebo Comparator: 0.4mg/kg infusion'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'ketamine (0.4mg/kg)\n\nKetamine: 0.4mg/kg infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'spread': '.23', 'groupId': 'OG000'}, {'value': '1', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (DOS) to 7 days (Post Op)', 'description': 'VAS Scores will be assessed on Day of Surgery (DOS), Post-op Day (POD) 1, 2 and 7. If patients have been discharged, coordinators will contact patient by home.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment/Placebo', 'description': 'saline infusion\n\nPlacebo Comparator: 0.4mg/kg infusion'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'ketamine (0.4mg/kg)\n\nKetamine: 0.4mg/kg infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 days', 'description': 'LOS will be recorded from medical record.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Opioid Usage Per Hour During the PACU Stay Before and After Ketamine Infusion', 'timeFrame': '8 Days', 'description': 'Length of stay and opioid usage will be recorded from electronic medical chart', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Opioid Usage Per Day Throughout the Hospital Stay', 'timeFrame': '8 days', 'description': 'recorded from medical chart', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Out of Bed to Chair (OOB)', 'timeFrame': '7 Days', 'description': 'Patient will be asked to record and report the time to OOB', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Spirometry Use 4 Hours After the Termination of Ketamine Infusion', 'timeFrame': '1 day', 'description': 'Spirometry use will be assessed by a study team member to determine whether the patient is meeting the goal set by the surgical team 4 hours after ketamine infusion.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Level of IL-1 After Ketamine Infusion', 'timeFrame': '1 day', 'description': 'changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Survey Scores - McGill's Short Form", 'timeFrame': 'Pre-op,Day of Surgery through Post-op Day 8', 'description': "Change in survey scores -- McGill's short form", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Survey Scores - Becks Depression Index (BDI)', 'timeFrame': 'Pre-op,Day of Surgery through Post-op Day 8', 'description': 'Change in survey scores for Becks Depression Index (BDI)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Survey Scores - QoR15', 'timeFrame': 'Pre-op,Day of Surgery through Post-op Day 8', 'description': 'Change in scores for Quality of Recovery 15 - QoR15', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Survey Scores - MADRS', 'timeFrame': 'Pre-op,Day of Surgery through Post-op Day 8', 'description': 'Change in scores for MADRS', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Level of IL-6 After Ketamine Infusion', 'timeFrame': '1 day', 'description': 'changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Level of TNF-α After Ketamine Infusion', 'timeFrame': '1 day', 'description': 'changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Level of BDNF After Ketamine Infusion', 'timeFrame': '1 day', 'description': 'changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment/Placebo', 'description': 'saline infusion\n\nPlacebo Comparator: 0.4mg/kg infusion'}, {'id': 'FG001', 'title': 'Treatment', 'description': 'ketamine (0.4mg/kg)\n\nKetamine: 0.4mg/kg infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo Comparator: 0.4mg/kg saline infusion'}, {'id': 'BG001', 'title': 'Ketamine', 'description': 'Ketamine: 0.4mg/kg infusion'}, {'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': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '90', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-20', 'size': 965818, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-12T11:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2015-04-16', 'resultsFirstSubmitDate': '2019-07-12', 'studyFirstSubmitQcDate': '2015-05-18', 'lastUpdatePostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-02', 'studyFirstPostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Opioid Usage Per Hour During the PACU Stay Before and After Ketamine Infusion', 'timeFrame': '8 Days', 'description': 'Length of stay and opioid usage will be recorded from electronic medical chart'}, {'measure': 'Opioid Usage Per Day Throughout the Hospital Stay', 'timeFrame': '8 days', 'description': 'recorded from medical chart'}, {'measure': 'Time to Out of Bed to Chair (OOB)', 'timeFrame': '7 Days', 'description': 'Patient will be asked to record and report the time to OOB'}, {'measure': 'Spirometry Use 4 Hours After the Termination of Ketamine Infusion', 'timeFrame': '1 day', 'description': 'Spirometry use will be assessed by a study team member to determine whether the patient is meeting the goal set by the surgical team 4 hours after ketamine infusion.'}, {'measure': 'Change in Serum Level of IL-1 After Ketamine Infusion', 'timeFrame': '1 day', 'description': 'changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.'}, {'measure': "Survey Scores - McGill's Short Form", 'timeFrame': 'Pre-op,Day of Surgery through Post-op Day 8', 'description': "Change in survey scores -- McGill's short form"}, {'measure': 'Survey Scores - Becks Depression Index (BDI)', 'timeFrame': 'Pre-op,Day of Surgery through Post-op Day 8', 'description': 'Change in survey scores for Becks Depression Index (BDI)'}, {'measure': 'Survey Scores - QoR15', 'timeFrame': 'Pre-op,Day of Surgery through Post-op Day 8', 'description': 'Change in scores for Quality of Recovery 15 - QoR15'}, {'measure': 'Survey Scores - MADRS', 'timeFrame': 'Pre-op,Day of Surgery through Post-op Day 8', 'description': 'Change in scores for MADRS'}, {'measure': 'Change in Serum Level of IL-6 After Ketamine Infusion', 'timeFrame': '1 day', 'description': 'changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.'}, {'measure': 'Change in Serum Level of TNF-α After Ketamine Infusion', 'timeFrame': '1 day', 'description': 'changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.'}, {'measure': 'Change in Serum Level of BDNF After Ketamine Infusion', 'timeFrame': '1 day', 'description': 'changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.'}], 'primaryOutcomes': [{'measure': 'Change in Pain Scores', 'timeFrame': 'Baseline (DOS) to 7 days (Post Op)', 'description': 'VAS Scores will be assessed on Day of Surgery (DOS), Post-op Day (POD) 1, 2 and 7. If patients have been discharged, coordinators will contact patient by home.'}], 'secondaryOutcomes': [{'measure': 'Length of Stay During Hospitalization', 'timeFrame': '8 days', 'description': 'LOS will be recorded from medical record.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['perioperative period', 'pain', 'gastric bypass'], 'conditions': ['Pain', 'Postoperative Depression']}, 'referencesModule': {'references': [{'pmid': '30095550', 'type': 'DERIVED', 'citation': 'Wang J, Echevarria GC, Doan L, Ekasumara N, Calvino S, Chae F, Martinez E, Robinson E, Cuff G, Franco L, Muntyan I, Kurian M, Schwack BF, Bedrosian AS, Fielding GA, Ren-Fielding CJ. Effects of a single subanaesthetic dose of ketamine on pain and mood after laparoscopic bariatric surgery: A randomised double-blind placebo controlled study. Eur J Anaesthesiol. 2019 Jan;36(1):16-24. doi: 10.1097/EJA.0000000000000860.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled, two-arm parallel, single-center study. One hundred subjects (50 in each arm) will be enrolled. Subjects, between the ages 18 and 65, undergoing laparoscopic gastric bypass or sleeve gastrectomy will be recruited and consented during the preadmission visit prior to surgery.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled, two-arm parallel, single-center study. One hundred subjects (50 in each arm) will be enrolled. Subjects, between the ages 18 and 65, undergoing laparoscopic gastric bypass or sleeve gastrectomy will be recruited and consented during the preadmission visit prior to surgery. Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ketamine (0.4mg/kg) or matching placebo. Both men and women will be recruited, and there is no limitation as to racial and ethnic origin. In the PACU, patients will receive either 0.4mg/kg IV ketamine or placebo. All patients will also receive standard post-anesthetic monitoring and care, as well as routine care after transfer out of the PACU. Patients are followed until the date of discharge, and endpoints (see below) are collected from patient reports as well as from medical charts. During their hospital stay (and once after their discharge from the hospital), patients will fill out five questionnaires which provide estimates of their postoperative pain control, mood and function, and quality of postsurgical recovery. An additional component of the study, which is entirely optional, is to obtain patient serum samples (about two teaspoons) in the operating room and 15 minutes and 4 hours after ketamine infusion. The investigators will use these samples to assess levels of IL-1, IL-6, TNF-α, and BDNF, which are markers for pain. In addition, with patient consent, the investigators will also store serum samples for future research use to measure other cytokines and neurotrophic factors and molecular markers associated with pain and depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults, \\>18 years, \\<65 years, who will undergo gastric bypass or sleeve gastrectomy.\n2. Subject is non-lactating and is either:\n\n * Not of childbearing potential; or\n * Of childbearing potential but is not pregnant at time of baseline as determined by pre-operative pregnancy testing.\n3. Subject is ASA physical status 1, 2, or 3.\n4. Subject who is deemed medically stable\n\nExclusion Criteria:\n\n1. \\<18 years of age; \\>65 years of age\n2. Pregnant or breastfeeding\n3. Does not speak or understand English (the study forms used are copy-righted in English)\n4. Cognitively impairment (by history) or clinical signs of altered mental status\n5. History of misuse or abuse of ketamine\n6. History of chest pain or chest pain in the PACU\n7. Use of a medication that interferes with metabolism of ketamine within the last 24 hours\n8. A diagnosis of schizophrenia and/ or a history of chronic antipsychotic medication use\n9. History of head trauma\n10. History of intracranial mass or hemorrhage\n11. History of stroke\n12. History of cardiac arrhythmia\n13. Subject for whom ketamine is contraindicated\n14. Unwillingness to give informed consent according to HIC guidelines'}, 'identificationModule': {'nctId': 'NCT02452060', 'briefTitle': 'Study on the Use of Low Dose Ketamine After Gastric Bypass and Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Randomized, Double-blind, Placebo Controlled Study on the Effect of a Single Postoperative Administration of Low Dose Ketamine After Gastric Bypass and Gastrectomy Surgeries', 'orgStudyIdInfo': {'id': '14-00472'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'treatment/placebo', 'description': 'saline infusion', 'interventionNames': ['Other: Placebo Comparator']}, {'type': 'EXPERIMENTAL', 'label': 'treatment', 'description': 'ketamine (0.4mg/kg)', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['ketalar'], 'description': '0.4mg/kg infusion', 'armGroupLabels': ['treatment']}, {'name': 'Placebo Comparator', 'type': 'OTHER', 'otherNames': ['Saline Infusion'], 'description': '0.4mg/kg infusion', 'armGroupLabels': ['treatment/placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jing Wang, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}