Clinical trial NCT03076827: Effects of Surgery Start Time on Postoperative Interleukin-6, Interleukin-8, and Cortisol
Official title: Comparison of Cortisol and Cytokines in Morning and Afternoon Surgerys According to Circadian Rhythm of Cortisol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiarthroplasty
Arthroplasty, Replacement, Hip
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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.

A 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%.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for hip hemiarthroplasty
* Patients scheduled for total hip replacement

Exclusion Criteria:

* Sleep disorder
* Mental disorder
* Psychiatric medication

Primary outcomes:
measure: Cortisol level
timeFrame: within the first 2 days after surgery
Secondary outcomes:
measure: Interleukin-6
timeFrame: within the first 2 days after surgery
measure: Interleukin-8
timeFrame: within the first 2 days after surgery
measure: Visual analogue scale
timeFrame: within the first 2 days after surgery
measure: Post-operative hospital stay
timeFrame: Hospital day after surgery.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology and Pain medicine, Chuncheon Sacred Heart Hospital,
name: Jae Jun Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.