Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-03-02 @ 3:42 PM
Study NCT ID:
NCT02087202
Status:
UNKNOWN
Last Update Posted:
2014-03-14
First Post:
2014-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperalgesia and NMDA Receptor Antagonist
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-12', 'studyFirstSubmitDate': '2014-03-12', 'studyFirstSubmitQcDate': '2014-03-12', 'lastUpdatePostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain', 'timeFrame': 'until 1 month from the end of the operation', 'description': 'pain (QST and pain measures )until 1 month from the end of the operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pain'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'NMDA receptor is administered and postoperative remote hyperalgesia is investigated.', 'detailedDescription': 'NMDA receptor is adminstered and postoperative tertiary hyperalgesia is investigated.\n\nQST and pain measures for remote hyperalgesia are compared between control and magnesium or ketamine group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA1-2\n\nExclusion Criteria:\n\n* contraindication to the study drugs'}, 'identificationModule': {'nctId': 'NCT02087202', 'briefTitle': 'Hyperalgesia and NMDA Receptor Antagonist', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Hyperalgesia and NMDA Receptor Antagonist', 'orgStudyIdInfo': {'id': 'hyperalgesia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'magnesium', 'description': 'magnesium is added perioperatively to those patients undergoing staged total knee arthroplasty and other surgeries.', 'interventionNames': ['Drug: Magnesium Sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'ketamine', 'description': 'ketamine is administered to those patients undergoing stated TKA and other operations.', 'interventionNames': ['Drug: ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'normal saline (placebo) is administered to the patients.'}], 'interventions': [{'name': 'Magnesium Sulfate', 'type': 'DRUG', 'description': 'magnesium sulfate is added to the patients', 'armGroupLabels': ['magnesium']}, {'name': 'ketamine', 'type': 'DRUG', 'description': 'ketamine is added to the patients.', 'armGroupLabels': ['ketamine']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'Kim Mihyun', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}