Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-02-24 @ 5:03 PM
Study NCT ID:
NCT02648958
Status:
COMPLETED
Last Update Posted:
2018-06-13
First Post:
2015-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dexmedetomidine on Ischemia-Reperfusion Injury in Lower Extremity Operations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-12', 'studyFirstSubmitDate': '2015-12-06', 'studyFirstSubmitQcDate': '2016-01-05', 'lastUpdatePostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes of malondialdehyde (μmol/L)', 'timeFrame': 'up to 1 day'}], 'secondaryOutcomes': [{'measure': 'changes of interleukin-6 (pg/ml)', 'timeFrame': 'up to 1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthroplasty, Replacement']}, 'descriptionModule': {'briefSummary': 'Ischemia reperfusion injury causes the release of free oxygen radicals. The selective alpha2-receptor agonist, dexmedetomidine, has an inhibitory effect on inflammatory responses during ischemic injury. The aim of this study is to evaluate the effect of dexmedetomidine on inflammatory responses during ischemia-reperfusion injury in skeletal muscle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society Anesthesiologists classification I-III\n\nExclusion Criteria:\n\n* use of antioxidants clinically significant cardiovascular, renal, or hepatic diseases heart block greater than the first degree'}, 'identificationModule': {'nctId': 'NCT02648958', 'briefTitle': 'Effect of Dexmedetomidine on Ischemia-Reperfusion Injury in Lower Extremity Operations', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effect of Dexmedetomidine on Ischemia-Reperfusion Injury in Unilateral Total Knee Replacement - a Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '4-2015-0794'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'The control group received saline instead of dexmedetomidine.', 'interventionNames': ['Drug: normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine group', 'description': 'The dexmedetomidine group received the dexmedetomidine.', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['precedex'], 'description': 'The dexmedetomidine group received the dexmedetomidine infusion at a rate of 0.4mg/kg/h after a loading dose of 0.5mg/kg for 10 minutes.', 'armGroupLabels': ['Dexmedetomidine group']}, {'name': 'normal saline', 'type': 'DRUG', 'description': 'The control group received the normal saline infusion', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'YONGSEON CHOI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}