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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076827
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Jae Jun Lee, Chuncheon Sacred Heart Hospital

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.

Condition or disease Intervention/treatment Phase
Hemiarthroplasty Arthroplasty, Replacement, Hip Procedure: Total hip replacement Procedure: Hemi-arthroplasty Not Applicable

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%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Comparison of Cortisol and Cytokines in Morning and Afternoon Surgerys According to Circadian Rhythm of Cortisol
Study Start Date : October 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

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.




Primary Outcome Measures :
  1. Cortisol level [ Time Frame: within the first 2 days after surgery ]
    Cortisol levels over time


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Sleep disorder
  • Mental disorder
  • Psychiatric medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076827


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

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jae Jun Lee, associate professor, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT03076827    
Other Study ID Numbers: Chuncheon201701
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents