Trials / Completed
CompletedNCT03076827
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Chuncheon Sacred Heart Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
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%.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2017-03-10
- Last updated
- 2017-11-14
Source: ClinicalTrials.gov record NCT03076827. Inclusion in this directory is not an endorsement.