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临床试验/NCT02331953
NCT02331953已完成不适用

Predictors of Postoperative Delirium in Elder Patients After Spine Surgery: Regional Cerebral Oxygen Saturation

Yonsei University1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
109
试验地点
1
主要终点
the predictive power of periopertiver rSO2 regarding postoperative delirium

研究概览

简要总结

Postoperative delirium is an important problem in patients undergoing major surgery. The incidence of delirium was 12.5% in the patients over 70 years old undergoing spine surgery. A study shows that a low preoperative regional cerebral oxygen saturation (rSO2) is associated with postoperative delirium after on-pump cardiac surgery. This same perturbation likely also increases the risk for postoperative delirium after spine surgery, although there are little data that have evaluated this hypothesis. Therefore, this observational study was designed to explore the relationship between perioperative rSO2 and the delirium in elderly patients undergoing spine surgery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in the study will be 60 or older undergoing elective major spine surgery (expected operative time is more than 2 hrs).
  • Patients who can do the mini-mental state examination (MMSE), Confusion Assessment Method for the ICU (CAM-ICU) and Intensive Care Delirium Screening Checklist (ICDSC).
  • Patients who understand the nature of the study and are willing to sign the consent form

排除标准

  • Emergency surgery
  • Patients diagnosed with neurocognitive disorders or psychiatric diseases, thus, cannot check MMSE or communicate with other people (e.g. Alzheimer's dementia, alcohol abuse)
  • Patients diagnosed with cerebrovascular disorders (e.g. stroke, atherosclerotic stenosis of carotid artery, TIA)
  • Patients who cannot be followed up until 2 days after surgery

结局指标

主要结局

the predictive power of periopertiver rSO2 regarding postoperative delirium

时间窗: up to 2days postoperative

The presence and severity of delirium were assessed with Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) once a day. (1 day preopertive, 2 days postoperative.) The investigators plan to evaluate whether periopertive rSO2 can predict postoperative delirium in elder patients after spine surgery and to assess the predictive power of periopertiver rSO2 regarding postoperative delirium. Perioperative rSO2 was observed during surgery (an expected average of 2\~3 hours).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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