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OpenTrials
Completed

NCT Number: NCT03076827

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

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Key information

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Sleep disorder
  • Mental disorder
  • Psychiatric medication

Treatment and study plan

Total hip replacement

Procedure

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

Hemi-arthroplasty

Procedure

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

Primary outcomes

  1. Cortisol level

    Time frame: within the first 2 days after surgery

    Cortisol levels over time

Secondary outcomes

  1. Interleukin-6

    Time frame: within the first 2 days after surgery

    Interleukin-6 levels over time

  2. Interleukin-8

    Time frame: within the first 2 days after surgery

    Interleukin-8 levels over time

  3. Visual analogue scale

    Time frame: within the first 2 days after surgery

    pain scale over time

  4. Post-operative hospital stay

    Time frame: Hospital day after surgery.

    Hospital day after surgery.

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 10, 2017
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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