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

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076827
• Other study ID #: Chuncheon201701
• Status: Completed
• Phase: N/A
• First received: January 30, 2017
• Last updated: November 9, 2017
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2017
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for hip hemiarthroplasty

• Patients scheduled for total hip replacement

Exclusion Criteria:

• Sleep disorder

• Mental disorder

• Psychiatric medication

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Hemiarthroplasty

Intervention

Procedure:
• Total hip replacement
Total hip replacement starts in the morning in group A and starts in the afternoon in group P.
• Hemi-arthroplasty
Hemi-arthroplasty starts in the morning in group A and starts in the afternoon in group P.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital

References & Publications (1)

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. Epub 2007 Jan 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortisol level	Cortisol levels over time	within the first 2 days after surgery
Secondary	Interleukin-6	Interleukin-6 levels over time	within the first 2 days after surgery
Secondary	Interleukin-8	Interleukin-8 levels over time	within the first 2 days after surgery
Secondary	Visual analogue scale	pain scale over time	within the first 2 days after surgery
Secondary	Post-operative hospital stay	Hospital day after surgery.	Hospital day after surgery.

External Links

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