Effects of Surgery Start Time on Postoperative Interleukin-6, Interleukin-8, and Cortisol
Comparison of Cortisol and Cytokines in Morning and Afternoon Surgerys According to Circadian Rhythm of Cortisol
1 other identifier
interventional
44
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 30, 2017
CompletedFirst Posted
Study publicly available on registry
March 10, 2017
CompletedNovember 14, 2017
November 1, 2017
1 year
January 30, 2017
November 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Cortisol level
Cortisol levels over time
within the first 2 days after surgery
Secondary Outcomes (4)
Interleukin-6
within the first 2 days after surgery
Interleukin-8
within the first 2 days after surgery
Visual analogue scale
within the first 2 days after surgery
Post-operative hospital stay
Hospital day after surgery.
Study Arms (2)
Group A
EXPERIMENTALGroup to begin surgery(total hip replacement or hip hemi-arthroplasty) in the morning
Group P
EXPERIMENTALGroup to begin surgery(total hip replacement or hip hemi-arthroplasty) in the afternoon
Interventions
Total hip replacement starts in the morning in group A and starts in the afternoon in group P.
Hemi-arthroplasty starts in the morning in group A and starts in the afternoon in group P.
Eligibility Criteria
You may qualify if:
- Patients scheduled for hip hemiarthroplasty
- Patients scheduled for total hip replacement
You may not qualify if:
- Sleep disorder
- Mental disorder
- Psychiatric medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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: 17228341BACKGROUNDKwon 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.
PMID: 31192911DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae Jun Lee, M.D.
Department of Anesthesiology and Pain medicine, Chuncheon Sacred Heart Hospital,
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
January 30, 2017
First Posted
March 10, 2017
Study Start
October 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
November 14, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will share