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临床试验/NCT03076827
NCT03076827已完成不适用

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

Chuncheon Sacred Heart Hospital0 个研究点目标入组 44 人开始时间: 2015年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
主要终点
Cortisol level

研究概览

简要总结

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.

详细描述

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%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Sleep disorder
  • Mental disorder
  • Psychiatric medication

结局指标

主要结局

Cortisol level

时间窗: within the first 2 days after surgery

Cortisol levels over time

次要结局

  • Interleukin-8(within the first 2 days after surgery)
  • Post-operative hospital stay(Hospital day after surgery.)
  • Interleukin-6(within the first 2 days after surgery)
  • Visual analogue scale(within the first 2 days after surgery)

研究者

发起方
Chuncheon Sacred Heart Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jae Jun Lee

associate professor

Chuncheon Sacred Heart Hospital

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