Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-02 @ 1:06 AM
Study NCT ID:
NCT03448068
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2018-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Perioperative Ketamine for Pain With Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D059039', 'term': 'Standard of Care'}], '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'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Gorlin.Andrew@mayo.edu', 'phone': '480-342-2446', 'title': 'Dr. Andrew W. Gorlin', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected 30 days following surgery for each participant, over a study duration of approximately 48 months', 'eventGroups': [{'id': 'EG000', 'title': 'Ketamine Therapy', 'description': 'Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 13, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Therapy', 'description': 'Subjects received standard of care anesthesia', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 11, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 19, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Cumulative Perioperative Opioid Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine Therapy', 'description': 'Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours'}, {'id': 'OG001', 'title': 'Standard Therapy', 'description': 'Subjects received standard of care anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '179.9', 'spread': '113.1', 'groupId': 'OG000'}, {'value': '248.6', 'spread': '91.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'approximately 48 hours after induction of anesthesia', 'description': 'Measured in oral morphine equivalents', 'unitOfMeasure': 'Morphine Equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Pain Score 0-12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine Therapy', 'description': 'Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours'}, {'id': 'OG001', 'title': 'Standard Therapy', 'description': 'Subjects received standard of care anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2252', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'approximately 0-12 hours post operatively', 'description': 'Patient reported pain scores at 0-12 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Pain Score 12-24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine Therapy', 'description': 'Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours'}, {'id': 'OG001', 'title': 'Standard Therapy', 'description': 'Subjects received standard of care anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0610', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'approximately 12-24 hours post operatively', 'description': 'Patient reported pain scores at 12-24 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Pain Score 24-48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine Therapy', 'description': 'Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours'}, {'id': 'OG001', 'title': 'Standard Therapy', 'description': 'Subjects received standard of care anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2720', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'approximately 24-48 hours post operatively', 'description': 'Patient reported pain scores at 24-48 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2 subjects were discharged early so data was not collected or analyzed for 1 subject from the ketamine therapy group and 1 subject from the standard therapy group'}, {'type': 'SECONDARY', 'title': 'Post-Operative Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine Therapy', 'description': 'Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours'}, {'id': 'OG001', 'title': 'Standard Therapy', 'description': 'Subjects received standard of care anesthesia'}], 'classes': [{'title': 'Nausea 1st 12 hours', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Nausea 2nd 12 hours', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Nausea 2nd 24 hours', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7298', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Nausea 1st 12 hours for Ketamine Therapy vs Standard Therapy', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1058', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Nausea 2nd 12 hours for Ketamine Therapy vs Standard Therapy', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Nausea 2nd 24 hours for Ketamine Therapy vs Standard Therapy', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 hours, 24 hours, and 48 hours', 'description': 'Number of subject to experience post-operative nausea', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay in Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine Therapy', 'description': 'Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours'}, {'id': 'OG001', 'title': 'Standard Therapy', 'description': 'Subjects received standard of care anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'spread': '18.0', 'groupId': 'OG000'}, {'value': '36.7', 'spread': '14.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Arrival at hospital until discharge from hospital, approximately 2 days', 'description': 'Length of hospital stay measured in hours', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Pain Control at Time of Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine Therapy', 'description': 'Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours'}, {'id': 'OG001', 'title': 'Standard Therapy', 'description': 'Subjects received standard of care anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately 1-2 days post-operatively', 'description': 'Self-reported questionnaire at the time of discharge from the hospital rating satisfaction of pain treatment while in the hospital using a scale of 0= extremely dissatisfied, 10 = extremely satisfied.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Pain Control at Postoperative Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine Therapy', 'description': 'Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours'}, {'id': 'OG001', 'title': 'Standard Therapy', 'description': 'Subjects received standard of care anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately 30 days post-operatively', 'description': 'Self-reported questionnaire at the time of first post-operative visit with the surgeon, rating the worst amount of pain since being discharged from the hospital using a scale of 0= no pain, 10 = worst pain possible.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketamine Therapy', 'description': 'Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours'}, {'id': 'FG001', 'title': 'Standard Therapy', 'description': 'Subjects received standard of care anesthesia'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketamine Therapy', 'description': 'Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours'}, {'id': 'BG001', 'title': 'Standard Therapy', 'description': 'Subjects received standard of care anesthesia'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.2', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '48.8', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '51.5', 'spread': '11.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', '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': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-12', 'size': 333844, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-04T11:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-05', 'studyFirstSubmitDate': '2018-02-09', 'resultsFirstSubmitDate': '2021-03-08', 'studyFirstSubmitQcDate': '2018-02-26', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-05', 'studyFirstPostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Cumulative Perioperative Opioid Dose', 'timeFrame': 'approximately 48 hours after induction of anesthesia', 'description': 'Measured in oral morphine equivalents'}], 'secondaryOutcomes': [{'measure': 'Average Pain Score 0-12 Hours', 'timeFrame': 'approximately 0-12 hours post operatively', 'description': 'Patient reported pain scores at 0-12 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.'}, {'measure': 'Average Pain Score 12-24 Hours', 'timeFrame': 'approximately 12-24 hours post operatively', 'description': 'Patient reported pain scores at 12-24 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.'}, {'measure': 'Average Pain Score 24-48 Hours', 'timeFrame': 'approximately 24-48 hours post operatively', 'description': 'Patient reported pain scores at 24-48 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.'}, {'measure': 'Post-Operative Nausea', 'timeFrame': '12 hours, 24 hours, and 48 hours', 'description': 'Number of subject to experience post-operative nausea'}, {'measure': 'Length of Stay in Hospital', 'timeFrame': 'Arrival at hospital until discharge from hospital, approximately 2 days', 'description': 'Length of hospital stay measured in hours'}, {'measure': 'Patient Satisfaction With Pain Control at Time of Hospital Discharge', 'timeFrame': 'approximately 1-2 days post-operatively', 'description': 'Self-reported questionnaire at the time of discharge from the hospital rating satisfaction of pain treatment while in the hospital using a scale of 0= extremely dissatisfied, 10 = extremely satisfied.'}, {'measure': 'Patient Satisfaction With Pain Control at Postoperative Visit', 'timeFrame': 'approximately 30 days post-operatively', 'description': 'Self-reported questionnaire at the time of first post-operative visit with the surgeon, rating the worst amount of pain since being discharged from the hospital using a scale of 0= no pain, 10 = worst pain possible.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laparoscopic Gastric Bypass Surgery', 'Ketamine']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Opioid medications such as morphine, hydrocodone and oxycodone are standard for treating pain after surgery, however there are disadvantages. Because of the way opioids work, gastric bypass patients may have an increased risk of having sedation or problems with breathing. In patients with sleep apnea, opioids may increase the risk of severe apnea.\n\nKetamine is an alternative pain medicine that can be used to treat pain after surgery and may have fewer effects on breathing. Using ketamine as part of the regimen may be a better choice for laparoscopic gastric bypass patients.\n\nThis study is being done to find out if intraoperative ketamine infusion combined with continuation for twenty-four hours post-surgery provides superior pain control and decreases post-operative opioid use versus standard non-ketamine therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients undergoing laparoscopic gastric bypass at Mayo Clinic in Arizona\n2. BMI is ≥ 35 kg/m2\n3. Consent is able to be obtained as per Mayo Clinic policy\n\nExclusion Criteria:\n\n1. Intolerance to ketamine\n2. History of schizophrenia, schizoaffective disorder, or other psychiatric diagnosis with psychotic features\n3. Presence of unstable cardiovascular disease (presence of acute coronary syndrome, unstable angina, hypertension emergency, acute transient ischemic attack (TIA) or stroke)\n4. Presence of acute elevation of intracranial or intraocular pressure\n5. Presence of seizure disorder\n6. History of substance abuse or addiction\n7. Creatinine greater than 1.5 mg/dL\n8. End-stage liver disease\n9. Pregnancy\n10. Patients with chronic pain and/or chronic opioid therapy will not be excluded to more closely replicate the study patient population of interest. However, patients taking greater than 50 morphine equivalents (ME) per day for greater than 1 month prior to surgery will be excluded.'}, 'identificationModule': {'nctId': 'NCT03448068', 'briefTitle': 'Perioperative Ketamine for Pain With Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Low-dose Ketamine Infusions for Perioperative Pain Management in Patients Undergoing Laparoscopic Gastric Bypass', 'orgStudyIdInfo': {'id': '17-000301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine Therapy', 'description': '1. Ketamine 0.3 mg/kg (IBW) bolus with induction.\n2. Ketamine infusion 0.2 mg/kg/hr. (IBW) initiated after induction and terminated after 24 hours.\n3. Ketamine infusion will not be titrated.\n4. Remaining care will be identical to standard therapy group.', 'interventionNames': ['Drug: Ketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Therapy', 'description': '1. Calculation ideal body weight (IBW)\n2. Pre-op dexamethasone\n3. Pre-op midazolam at discretion of anesthesiologist\n4. Anesthesia Induction - Propofol and fentanyl, anesthesiologist discretion. Neuromuscular block with succinylcholine and/or rocuronium at discretion of anesthesiologist. Orotracheal intubation.\n5. Anesthesia Maintenance - Sevoflurane/rocuronium. Addl. doses of fentanyl, discretion of anesthesiologist.\n6. Emergence from anesthesia - Acetaminophen, Ketorolac and Ondansetron unless contraindicated. Sugammadex depending on twitch response per drug manufacturer recommended protocol.\n7. Post-Op Analgesia - Hydromorphone, acetaminophen and ketorolac\n8. Other post-op care as per usual surgical routine', 'interventionNames': ['Drug: Standard therapy']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'Ketamine 0.3 mg/kg (IBW) bolus with induction. Ketamine infusion 0.2mg/kg/hr. (IBW) initiated after induction and terminated after 24 hours.\n\nKetamine infusion not titrated.', 'armGroupLabels': ['Ketamine Therapy']}, {'name': 'Standard therapy', 'type': 'DRUG', 'description': 'Pre-op dexamethasone 4mg IV and midazolam 1-2mg IV Anesthesia Induction - Propofol 2-3mg/kg IV, Fentanyl 1mcg/kg IV, neuromuscular block w/succinylcholine and/or rocuronium, orotracheal intubation Anesthesia maintenance - Sevoflurane/rocuronium, fentanyl 0.5-1mcg/kg Anesthesia emergence - Acetaminophen 1g, ketorolac 30 mg IV, ondansetron 4mg IV, sugammadex 2mg/kg or 4 mg/kg dose depending on twitch Post-op anesthesia - Hydromorphone patient-controlled analgesia (PCA) 0.2 mg/8 min, acetaminophen 1 g IV Q8 around the clock (ATC) x 3 addl. doses, ketorolac 15 mg IV Q6 ATC x 3 addl. doses.\n\nOther standard surgical post-op care', 'armGroupLabels': ['Standard Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Andrew W Gorlin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesiology, College of Medicine', 'investigatorFullName': 'Andrew Gorlin, MD', 'investigatorAffiliation': 'Mayo Clinic'}}}}