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

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.

Study Overview

• Status: Completed
• Conditions: Hemiarthroplasty; Arthroplasty, Replacement, Hip
• Intervention / Treatment: Procedure: Total hip replacement; Procedure: Hemi-arthroplasty

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%.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for hip hemiarthroplasty
• Patients scheduled for total hip replacement

Exclusion Criteria:

• Sleep disorder
• Mental disorder
• Psychiatric medication

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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.

Collaborators and Investigators

• Sponsor: Chuncheon Sacred Heart Hospital
• Investigators: Principal Investigator: Jae Jun Lee, M.D., Department of Anesthesiology and Pain medicine, Chuncheon Sacred Heart Hospital,

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Click here for more information about background of this study

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Chuncheon201701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes