Effects of Surgery Start Time on Postoperative Interleukin-6, Interleukin-8, and Cortisol

Study Overview
=================
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%.

Official Title
-----------------
Comparison of Cortisol and Cytokines in Morning and Afternoon Surgerys According to Circadian Rhythm of Cortisol

Conditions
-----------------
Hemiarthroplasty, Arthroplasty, Replacement, Hip

Intervention / Treatment
-----------------
* Procedure: Total hip replacement
* Procedure: Hemi-arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for hip hemiarthroplasty Patients scheduled for total hip replacement Exclusion Criteria: Sleep disorder Mental disorder Psychiatric medication

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Group to begin surgery(total hip replacement or hip hemi-arthroplasty) in the morning | Procedure: Total hip replacement<br>* Total hip replacement starts in the morning in group A and starts in the afternoon in group P.<br>Procedure: Hemi-arthroplasty<br>* Hemi-arthroplasty starts in the morning in group A and starts in the afternoon in group P.<br>|
| Experimental: Group P<br>Group to begin surgery(total hip replacement or hip hemi-arthroplasty) in the afternoon | Procedure: Total hip replacement<br>* Total hip replacement starts in the morning in group A and starts in the afternoon in group P.<br>Procedure: Hemi-arthroplasty<br>* Hemi-arthroplasty starts in the morning in group A and starts in the afternoon in group P.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol level | Cortisol levels over time | within the first 2 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-6 | Interleukin-6 levels over time | within the first 2 days after surgery | 
| Interleukin-8 | Interleukin-8 levels over time | within the first 2 days after surgery | 
| Visual analogue scale | pain scale over time | within the first 2 days after surgery | 
| Post-operative hospital stay | Hospital day after surgery. | Hospital day after surgery. |