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

NCT ID: NCT03076827

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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%.

Conditions

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Hemiarthroplasty Arthroplasty, Replacement, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Group to begin surgery(total hip replacement or hip hemi-arthroplasty) in the morning

Group Type EXPERIMENTAL

Total hip replacement

Intervention Type PROCEDURE

Total hip replacement starts in the morning in group A and starts in the afternoon in group P.

Hemi-arthroplasty

Intervention Type PROCEDURE

Hemi-arthroplasty starts in the morning in group A and starts in the afternoon in group P.

Group P

Group to begin surgery(total hip replacement or hip hemi-arthroplasty) in the afternoon

Group Type EXPERIMENTAL

Total hip replacement

Intervention Type PROCEDURE

Total hip replacement starts in the morning in group A and starts in the afternoon in group P.

Hemi-arthroplasty

Intervention Type PROCEDURE

Hemi-arthroplasty starts in the morning in group A and starts in the afternoon in group P.

Interventions

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Total hip replacement

Total hip replacement starts in the morning in group A and starts in the afternoon in group P.

Intervention Type PROCEDURE

Hemi-arthroplasty

Hemi-arthroplasty starts in the morning in group A and starts in the afternoon in group P.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Sleep disorder
* Mental disorder
* Psychiatric medication
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chuncheon Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae Jun Lee

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae Jun Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain medicine, Chuncheon Sacred Heart Hospital,

References

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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.

Reference Type BACKGROUND
PMID: 17228341 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31192911 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/?term=neuropsychipharmacology+2007+32++1622-1628

Click here for more information about background of this study

Other Identifiers

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Chuncheon201701

Identifier Type: -

Identifier Source: org_study_id