Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-03-08 @ 11:00 PM
Study NCT ID:
NCT02573558
Status:
COMPLETED
Last Update Posted:
2016-04-06
First Post:
2015-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Sedation and Postoperative Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 855}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-05', 'studyFirstSubmitDate': '2015-10-06', 'studyFirstSubmitQcDate': '2015-10-07', 'lastUpdatePostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Myocardial ischemia', 'timeFrame': 'within 7 day postoperatively'}, {'measure': 'Renal failure', 'timeFrame': 'within 7 day postoperatively'}, {'measure': 'Hepatic failure', 'timeFrame': 'within 7 day postoperatively'}], 'primaryOutcomes': [{'measure': 'delirium', 'timeFrame': 'within 7 day postoperatively'}], 'secondaryOutcomes': [{'measure': 'Wound infection', 'timeFrame': 'within 7 day postoperatively'}, {'measure': 'Pulmonary thromboembolism', 'timeFrame': 'within 7 day postoperatively'}, {'measure': 'Hospital stay', 'timeFrame': 'through study completion, an average of 7days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Orthopedics']}, 'descriptionModule': {'briefSummary': 'Delirium are common after orthopedic surgery in the elderly and are directly associated with loss of independence, reduction in the quality of life and increased mortality. The cause of postoperative delirium still remains unclear and may be multifactorial. The aim of this retrospective study is to examine prevalence of postoperative delirium according to the use of dexmedetomidine or propofol in elderly patients undergoing orthopedic surgery under regional anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent orthopedic surgery under regional anesthesia, and age of 65 years or greater', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who underwent orthopedic surgery under regional anesthesia\n* age of 65 years or greater\n\nExclusion Criteria:\n\n* General anesthesia\n* age \\< 65 years\n* central nervous system disease, including dementia and Parkinson's disease\n* Patients who were not received sedation with propofol or dexmedetomidine during the operation"}, 'identificationModule': {'nctId': 'NCT02573558', 'briefTitle': 'Intraoperative Sedation and Postoperative Delirium', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Prevalence of Postoperative Delirium According to the Use of Dexmedetomidine or Propofol in Elderly Patients Undergoing Orthopedic Surgery: Retrospective Study', 'orgStudyIdInfo': {'id': 'B-1510/318-104'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DEX', 'description': 'patients who received dexmedetomidine during the operation', 'interventionNames': ['Drug: Dexmedetomidine']}, {'label': 'PPF', 'description': 'patients who received propofol during the operation', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'armGroupLabels': ['DEX']}, {'name': 'Propofol', 'type': 'DRUG', 'armGroupLabels': ['PPF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hyo-Seok Na', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}