Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT02334059
Status:
COMPLETED
Last Update Posted:
2020-06-01
First Post:
2014-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D008274', 'term': 'Magnesium'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sadhikary1@pennstatehealth.psu.edu', 'phone': '717-531-6597', 'title': 'Sanjib D Adhikary', 'organization': 'Penn State Health Anesthesiology and Perioperative Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Perioperative time period (within 24 hours) up to 24 hours post surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Ketamine', 'description': 'Ketamine: 0.5 mg/kg IV dose\n\nKetamine: Ketamine infusion plus placebo infusion of normal saline\n\nPlacebo: 2 placebo infusions', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ketamine Plus Magnesium', 'description': 'Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV\n\nKetamine plus magnesium: Ketamine plus magnesium infusion', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo (normal saline)\n\nPlacebo: 2 placebo infusions', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Hydromorphone Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Ketamine: 0.5 mg/kg IV dose\n\nKetamine: Ketamine infusion plus placebo infusion of normal saline\n\nPlacebo: 2 placebo infusions'}, {'id': 'OG001', 'title': 'Ketamine Plus Magnesium', 'description': 'Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV\n\nKetamine plus magnesium: Ketamine plus magnesium infusion'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (normal saline)\n\nPlacebo: 2 placebo infusions'}], 'classes': [{'title': 'Intraoperative', 'categories': [{'measurements': [{'value': '161.5', 'groupId': 'OG000', 'lowerLimit': '119.6', 'upperLimit': '203.3'}, {'value': '159.6', 'groupId': 'OG001', 'lowerLimit': '109.4', 'upperLimit': '209.7'}, {'value': '195.9', 'groupId': 'OG002', 'lowerLimit': '149.6', 'upperLimit': '242.3'}]}]}, {'title': 'PACU', 'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000', 'lowerLimit': '20.5', 'upperLimit': '63.3'}, {'value': '47.8', 'groupId': 'OG001', 'lowerLimit': '24.6', 'upperLimit': '71.0'}, {'value': '47.3', 'groupId': 'OG002', 'lowerLimit': '24.1', 'upperLimit': '70.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During surgery and 24 hours post-op', 'description': 'Total hydromorphone use in 1st 24 hours post-operatively.', 'unitOfMeasure': 'mcg/Kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Scores Using Verbal Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Ketamine: 0.5 mg/kg IV dose\n\nKetamine: Ketamine infusion plus placebo infusion of normal saline\n\nPlacebo: 2 placebo infusions'}, {'id': 'OG001', 'title': 'Ketamine Plus Magnesium', 'description': 'Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV\n\nKetamine plus magnesium: Ketamine plus magnesium infusion'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (normal saline)\n\nPlacebo: 2 placebo infusions'}], 'classes': [{'title': 'Prior to Surgery', 'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000', 'lowerLimit': '-0.03', 'upperLimit': '0.84'}, {'value': '0.35', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.68'}, {'value': '0.27', 'groupId': 'OG002', 'lowerLimit': '-0.08', 'upperLimit': '0.62'}]}]}, {'title': 'PACU', 'categories': [{'measurements': [{'value': '5.78', 'groupId': 'OG000', 'lowerLimit': '4.86', 'upperLimit': '6.71'}, {'value': '6.03', 'groupId': 'OG001', 'lowerLimit': '4.86', 'upperLimit': '6.78'}, {'value': '5.95', 'groupId': 'OG002', 'lowerLimit': '4.91', 'upperLimit': '6.98'}]}]}, {'title': '4h after surgery', 'categories': [{'measurements': [{'value': '3.89', 'groupId': 'OG000', 'lowerLimit': '3.20', 'upperLimit': '4.57'}, {'value': '4.29', 'groupId': 'OG001', 'lowerLimit': '3.53', 'upperLimit': '5.06'}, {'value': '4.65', 'groupId': 'OG002', 'lowerLimit': '4.01', 'upperLimit': '5.29'}]}]}, {'title': '8h after surgery', 'categories': [{'measurements': [{'value': '3.67', 'groupId': 'OG000', 'lowerLimit': '3.09', 'upperLimit': '4.24'}, {'value': '3.75', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '4.60'}, {'value': '3.64', 'groupId': 'OG002', 'lowerLimit': '3.08', 'upperLimit': '4.20'}]}]}, {'title': '12h after surgery', 'categories': [{'measurements': [{'value': '3.16', 'groupId': 'OG000', 'lowerLimit': '2.59', 'upperLimit': '3.73'}, {'value': '3.91', 'groupId': 'OG001', 'lowerLimit': '3.28', 'upperLimit': '4.53'}, {'value': '2.69', 'groupId': 'OG002', 'lowerLimit': '2.07', 'upperLimit': '3.30'}]}]}, {'title': '16h after surgery', 'categories': [{'measurements': [{'value': '2.97', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '3.64'}, {'value': '3.64', 'groupId': 'OG001', 'lowerLimit': '2.89', 'upperLimit': '4.38'}, {'value': '3.09', 'groupId': 'OG002', 'lowerLimit': '2.51', 'upperLimit': '3.66'}]}]}, {'title': '20h after surgery', 'categories': [{'measurements': [{'value': '3.22', 'groupId': 'OG000', 'lowerLimit': '2.42', 'upperLimit': '4.01'}, {'value': '4.13', 'groupId': 'OG001', 'lowerLimit': '3.45', 'upperLimit': '4.8'}, {'value': '2.94', 'groupId': 'OG002', 'lowerLimit': '2.36', 'upperLimit': '3.53'}]}]}, {'title': '24h after surgery', 'categories': [{'measurements': [{'value': '3.24', 'groupId': 'OG000', 'lowerLimit': '2.59', 'upperLimit': '3.88'}, {'value': '3.48', 'groupId': 'OG001', 'lowerLimit': '2.81', 'upperLimit': '4.15'}, {'value': '3.33', 'groupId': 'OG002', 'lowerLimit': '2.63', 'upperLimit': '4.04'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Preoperatively and the 1st 24 hours post-op', 'description': 'Pain scores using VAS scale will be recorded pre-operatively, in the PACU, and every 4 hours until 24 hours post-op. The VAS is a 10 point scale, where 0 = no pain and 10 = the worst pain a subject has ever felt. The highest value 10, indicates an extreme self reported level of pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Ketamine: 0.5 mg/kg IV dose\n\nKetamine: Ketamine infusion plus placebo infusion of normal saline\n\nPlacebo: 2 placebo infusions'}, {'id': 'OG001', 'title': 'Ketamine Plus Magnesium', 'description': 'Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV\n\nKetamine plus magnesium: Ketamine plus magnesium infusion'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (normal saline)\n\nPlacebo: 2 placebo infusions'}], 'classes': [{'categories': [{'measurements': [{'value': '4.05', 'groupId': 'OG000', 'lowerLimit': '3.74', 'upperLimit': '4.35'}, {'value': '4.02', 'groupId': 'OG001', 'lowerLimit': '3.73', 'upperLimit': '4.32'}, {'value': '4.34', 'groupId': 'OG002', 'lowerLimit': '3.98', 'upperLimit': '4.71'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative period', 'description': 'The average MAC concentration of desflurane will be recorded during the intraoperative period. The Minimum Alveolar Concentration (MAC) of an inhaled anesthetic is the alveolar (or end-expiratory) concentration at which 50% of patients will not show a motor response to a standardized surgical incision.', 'unitOfMeasure': 'Minimal Alveolar Concentration (MAC)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intraoperative period: Intraoperative Minimum Alveolar Concentration (MAC) of desflurane'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketamine', 'description': 'Ketamine: 0.5 mg/kg IV dose\n\nKetamine: Ketamine infusion plus placebo infusion of normal saline\n\nPlacebo: 2 placebo infusions'}, {'id': 'FG001', 'title': 'Ketamine Plus Magnesium', 'description': 'Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV\n\nKetamine plus magnesium: Ketamine plus magnesium infusion'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo (normal saline)\n\nPlacebo: 2 placebo infusions'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketamine', 'description': 'Ketamine: 0.5 mg/kg IV dose\n\nKetamine: Ketamine infusion plus placebo infusion of normal saline\n\nPlacebo: 2 placebo infusions'}, {'id': 'BG001', 'title': 'Ketamine Plus Magnesium', 'description': 'Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV\n\nKetamine plus magnesium: Ketamine plus magnesium infusion'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo (normal saline)\n\nPlacebo: 2 placebo infusions'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '43.68', 'spread': '10.82', 'groupId': 'BG000'}, {'value': '44.15', 'spread': '11.91', 'groupId': 'BG001'}, {'value': '39.97', 'spread': '11.60', 'groupId': 'BG002'}, {'value': '42.56', 'spread': '11.49', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], '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': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '47.48', 'spread': '9.85', 'groupId': 'BG000'}, {'value': '45.57', 'spread': '6.73', 'groupId': 'BG001'}, {'value': '47.37', 'spread': '8.70', 'groupId': 'BG002'}, {'value': '46.84', 'spread': '8.53', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Surgery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '55.14', 'spread': '8.25', 'groupId': 'BG000'}, {'value': '67.06', 'spread': '15.12', 'groupId': 'BG001'}, {'value': '64.78', 'spread': '13.23', 'groupId': 'BG002'}, {'value': '62.19', 'spread': '13.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pre-operative Pain Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.27', 'spread': '1.04', 'groupId': 'BG000'}, {'value': '0.35', 'spread': '0.95', 'groupId': 'BG001'}, {'value': '0.41', 'spread': '1.3', 'groupId': 'BG002'}, {'value': '0.34', 'spread': '1.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Pain Scores will be determined pre-operatively using the Visual Analogue Scale (VAS). The VAS is a 10 point scale, where 0 = no pain and 10 = worst pain a subject has ever felt.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pre-operative sedation score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': '0.0', 'groupId': 'BG000'}, {'value': '1.97', 'spread': '0.17', 'groupId': 'BG001'}, {'value': '2', 'spread': '0.16', 'groupId': 'BG002'}, {'value': '2', 'spread': '0.14', 'groupId': 'BG003'}]}]}], 'paramType': 'MEDIAN', 'description': 'Sedation scoring will be determined using the Modified Ramsay Sedation Scale. The Modified Ramsay Sedation Scale is a 6 point scale used to determine alertness, where 1 = patient is awake, anxious, agitated, or restless and 6 = patient with no response to any stimuli (light, noise, or pain). A higher number represents an increased sedative state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pre-operative PONV score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.50', 'groupId': 'BG000'}, {'value': '0.03', 'spread': '0.17', 'groupId': 'BG001'}, {'value': '0.14', 'spread': '0.54', 'groupId': 'BG002'}, {'value': '0.11', 'spread': '0.44', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Pre-Operative PONV score will be determined using the PONV Impact Scale. This scale consists of two questions (rated from 0 to 3) for both questions and the sum of the responses are added for a total PONV score.\n\nQuestion 1 asks if an individual has vomited or had any dry retching, where 0 = Not at all, 1 = Once, 2= Twice, and 3= Three or more times.\n\nQuestion 2 asks if an individual has experienced a feeling of nausea, where 0 = Not at all, 1 = Sometimes, 2 = Often or most of the time, and 3 = All of the time.\n\ntotal score (mean and std deviation) is reported and total ranges from 0-3.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-11', 'size': 285626, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-10T16:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-15', 'studyFirstSubmitDate': '2014-12-23', 'resultsFirstSubmitDate': '2019-07-15', 'studyFirstSubmitQcDate': '2015-01-05', 'lastUpdatePostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-01', 'studyFirstPostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Hydromorphone Use', 'timeFrame': 'During surgery and 24 hours post-op', 'description': 'Total hydromorphone use in 1st 24 hours post-operatively.'}], 'secondaryOutcomes': [{'measure': 'Pain Scores Using Verbal Analogue Scale (VAS)', 'timeFrame': 'Preoperatively and the 1st 24 hours post-op', 'description': 'Pain scores using VAS scale will be recorded pre-operatively, in the PACU, and every 4 hours until 24 hours post-op. The VAS is a 10 point scale, where 0 = no pain and 10 = the worst pain a subject has ever felt. The highest value 10, indicates an extreme self reported level of pain.'}, {'measure': 'Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane', 'timeFrame': 'Intraoperative period', 'description': 'The average MAC concentration of desflurane will be recorded during the intraoperative period. The Minimum Alveolar Concentration (MAC) of an inhaled anesthetic is the alveolar (or end-expiratory) concentration at which 50% of patients will not show a motor response to a standardized surgical incision.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['opioid sparing', 'ketamine', 'obese', 'magnesium'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Opioid sparing analgesia is extremely important in the post-operative obese population. With more and more obese patients entering the operating room a multi-modal approach to analgesia is crucial. Finding effective alternatives to opioid therapy is the rationale of this proposal. Literature involving ketamine and magnesium in bariatric surgical patients is very sparse.', 'detailedDescription': '1. Patient will be identified by surgeon and consented by member of the research team\n2. Patient will be randomized to one of three groups on the day of surgery\n3. Following securement of the endotracheal tube, the study medication will be administered over 10 minutes via an IV infusion pump.\n4. The subject will receive ketamine, ketamine plus magnesium or a placebo.\n5. Following surgery, the patient will be taken to the post anesthesia care unit (PACU) and set up with standard ASA monitoring as well as end-tidal CO2 via nasal cannula. A hydromorphone patient controlled analgesia (PCA) pump will be set-up by nursing and given to the patient. Standard dosing of 0.2 mg bolus, every 6 minutes with a maximum 2 mg will be the starting dose as is standard for these patients post-operatively.\n6. Primary outcome will be the total amount of hydromorphone used in the first 24 hours post-operatively.\n\n .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects undergoing laparoscopic sleeve gastrectomy\n2. Consenting adults age 18-80\n3. ASA II to ASA III\n4. Ability to understand and use a PCA\n5. Required to be hospitalized for at least 24 hours post-op\n\nExclusion Criteria:\n\n1. Patient refusal\n2. Chronic opiate use (daily opiate use for \\>3 months)\n3. Chronic Kidney disease (Creatinine\\>2)\n4. Known allergy or adverse effect of ketamine, magnesium or hydromorphone\n5. Patients with documented psychiatry (Maniac or MDP) history\n6. Patient unable to give informed consent\n7. Patient with limited or no English fluency'}, 'identificationModule': {'nctId': 'NCT02334059', 'briefTitle': 'Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery', 'orgStudyIdInfo': {'id': 'STUDY00001623'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine', 'description': 'Ketamine: 0.5 mg/kg IV dose', 'interventionNames': ['Drug: Ketamine', 'Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine plus magnesium', 'description': 'Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV', 'interventionNames': ['Drug: Ketamine plus magnesium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (normal saline)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'Ketamine infusion plus placebo infusion of normal saline', 'armGroupLabels': ['Ketamine']}, {'name': 'Ketamine plus magnesium', 'type': 'DRUG', 'description': 'Ketamine plus magnesium infusion', 'armGroupLabels': ['Ketamine plus magnesium']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Normal Saline'], 'description': '2 placebo infusions', 'armGroupLabels': ['Ketamine', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Milton S.Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Sanjib Adhikary, MB, BS,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PSHMC College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, Department of Anesthesiology,', 'investigatorFullName': 'Sanjib D Adhikary', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}