Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-01-17 @ 5:32 PM
Study NCT ID:
NCT03076827
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2017-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Surgery Start Time on Postoperative Interleukin-6, Interleukin-8, and Cortisol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019644', 'term': 'Arthroplasty, Replacement, Hip'}, {'id': 'D062785', 'term': 'Hemiarthroplasty'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients receiving total hip replacement or hip hemiarthroplasty are divided into two groups: the morning surgery group and the afternoon surgery group. After surgery, cortisol, IL-6, IL-8 and VAS were measured and compared.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-09', 'studyFirstSubmitDate': '2017-01-30', 'studyFirstSubmitQcDate': '2017-03-06', 'lastUpdatePostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cortisol level', 'timeFrame': 'within the first 2 days after surgery', 'description': 'Cortisol levels over time'}], 'secondaryOutcomes': [{'measure': 'Interleukin-6', 'timeFrame': 'within the first 2 days after surgery', 'description': 'Interleukin-6 levels over time'}, {'measure': 'Interleukin-8', 'timeFrame': 'within the first 2 days after surgery', 'description': 'Interleukin-8 levels over time'}, {'measure': 'Visual analogue scale', 'timeFrame': 'within the first 2 days after surgery', 'description': 'pain scale over time'}, {'measure': 'Post-operative hospital stay', 'timeFrame': 'Hospital day after surgery.', 'description': 'Hospital day after surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hemiarthroplasty', 'Arthroplasty, Replacement, Hip']}, 'referencesModule': {'references': [{'pmid': '17228341', 'type': 'BACKGROUND', 'citation': 'Popma A, Doreleijers TA, Jansen LM, Van Goozen SH, Van Engeland H, Vermeiren R. The diurnal cortisol cycle in delinquent male adolescents and normal controls. Neuropsychopharmacology. 2007 Jul;32(7):1622-8. doi: 10.1038/sj.npp.1301289. Epub 2007 Jan 17.'}, {'pmid': '31192911', 'type': 'DERIVED', 'citation': 'Kwon YS, Jang JS, Hwang SM, Tark H, Kim JH, Lee JJ. Effects of surgery start time on postoperative cortisol, inflammatory cytokines, and postoperative hospital day in hip surgery: Randomized controlled trial. Medicine (Baltimore). 2019 Jun;98(24):e15820. doi: 10.1097/MD.0000000000015820.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=neuropsychipharmacology+2007+32++1622-1628', 'label': 'Click here for more information about background of this study'}]}, 'descriptionModule': {'briefSummary': 'Cortisol is a hormone that increases after trauma or surgery and has circadian rhythm. It has a form that is increased in the morning and decreased in the evening. The investigators expected to be influenced by circadian rhythm according to the time of operation, and compared morning and afternoon surgery.', 'detailedDescription': '44 patients to undergo hip hemiarthroplasty or total hip replacement were divided to morning surgery group(Group A) and afternoon surgery group(Group P). All surgery was done by the same orthopedic surgeon. Anesthesia of Group A was started at 8 a.m. and Group P was at 12\\~2 p.m. Blood sampling was performed at 7:30 a.m., after induction of anesthesia, 6, 12, 24 and 48 hours after surgery in all patients of both groups. Cortisol, IL-6, and IL-8 was measured immediately after blood sampling. Visual analogue scale(VAS) was used to assess the degree of pain at before start of anesthesia, 6, 12, 24 and 48 hours after surgery. The postoperative hospital stay was calculated. Postoperative management was done by the same management team. Surgical wounds were treated at the same 24 hour intervals.\n\nA sample size was calculated to differentiate between groups. Because difference of cortisol according to groups in ANOVA based on pilot study, the sample size was 20 patients per group. (Effect size f(v)= 0.5297047, α=0.05, 1-β=0.90) The investigators recruited total 44 patients to cover dropout 10%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for hip hemiarthroplasty\n* Patients scheduled for total hip replacement\n\nExclusion Criteria:\n\n* Sleep disorder\n* Mental disorder\n* Psychiatric medication'}, 'identificationModule': {'nctId': 'NCT03076827', 'briefTitle': 'Effects of Surgery Start Time on Postoperative Interleukin-6, Interleukin-8, and Cortisol', 'organization': {'class': 'OTHER', 'fullName': 'Chuncheon Sacred Heart Hospital'}, 'officialTitle': 'Comparison of Cortisol and Cytokines in Morning and Afternoon Surgerys According to Circadian Rhythm of Cortisol', 'orgStudyIdInfo': {'id': 'Chuncheon201701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Group to begin surgery(total hip replacement or hip hemi-arthroplasty) in the morning', 'interventionNames': ['Procedure: Total hip replacement', 'Procedure: Hemi-arthroplasty']}, {'type': 'EXPERIMENTAL', 'label': 'Group P', 'description': 'Group to begin surgery(total hip replacement or hip hemi-arthroplasty) in the afternoon', 'interventionNames': ['Procedure: Total hip replacement', 'Procedure: Hemi-arthroplasty']}], 'interventions': [{'name': 'Total hip replacement', 'type': 'PROCEDURE', 'description': 'Total hip replacement starts in the morning in group A and starts in the afternoon in group P.', 'armGroupLabels': ['Group A', 'Group P']}, {'name': 'Hemi-arthroplasty', 'type': 'PROCEDURE', 'description': 'Hemi-arthroplasty starts in the morning in group A and starts in the afternoon in group P.', 'armGroupLabels': ['Group A', 'Group P']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jae Jun Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Pain medicine, Chuncheon Sacred Heart Hospital,'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chuncheon Sacred Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Jae Jun Lee', 'investigatorAffiliation': 'Chuncheon Sacred Heart Hospital'}}}}