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临床试验/NCT04518839
NCT04518839Unknown不适用

The Comparison of Cognitive Function, Symptoms of Depression and Anxiety, and Quality of Life in Patients After Hip Fracture Surgery Under General or Regional Anesthesia

University of Zagreb0 个研究点目标入组 140 人开始时间: 2020年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
140
主要终点
change in cognition

研究概览

简要总结

Postoperative cognitive dysfunction is a relatively common in elderly patients after hip surgery, but exact mechanism of its onset is still unclear as well as contributing factors. There is also increased incidence of depression and anxiety. Both affect the recovery after surgery, slow it down and reduce the quality of life. Patients will be divided into two groups, operated under regional anaesthesia and operated under general anaesthesia, and monitored after surgery. Patients will be tested before and after surgery to evaluate postoperative cognitive deficits, depression and anxiety scale and health-related quality of life questionnaire.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients intended for surgical treatment of hip fractures ≥ 60 years
  • Patients who are category ASA I to ASA III will be included in research
  • Sufficient cognitive ability
  • Only those patients who have agreed to be participants in the research and have signed the consent for participation and informed consent.

排除标准

  • Patients who refused to participate in the survey and who did not sign informed consent
  • Patients with ASA IV or more
  • Patients under 60 years
  • Severe psychiatric disorders involving the use of psychopharmaceuticals back three months
  • All patients who have other fractures in addition to hip fractures
  • Polytrauma
  • All patients scheduled for more than one surgical intervention during the procedure, or within the next 8 weeks
  • Patients who have been diagnosed with dementia, and / or are receiving anti-dementia drugs

结局指标

主要结局

change in cognition

时间窗: preoperatively/postoperative follow up 2 months

MoCA scale (Montreal Cognitive Assessment), F-A-S test

change in anxiety and depression

时间窗: preoperatively/postoperative follow up 2 months

The HAD Scale (The Hospital Anxiety and Depression Scale)

change in quality of life

时间窗: preoperatively/postoperative follow up 2 months

EQ-5D-5L Questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tea Fabijanić, MD

MD

University of Zagreb

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