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临床试验/NCT01839227
NCT01839227已完成不适用

Post-operative Cognitive Dysfunction and the Change of Regional Cerebral Oxygen Saturation in Elderly Patients Undergoing Spinal Surgery

Yonsei University2 个研究点 分布在 2 个国家目标入组 87 人开始时间: 2012年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
87
试验地点
2
主要终点
K-MMSE

研究概览

简要总结

Post operative cognitive dysfunction (POCD) is a well-recognized complication of patients undergoing cardiac surgery. Previous studies reported near-infrared spectroscopy provides information on the occurrence of cerebral desaturation resulted in POCD. But evidence of POCD after general surgery has been lacking. Especially, the prone position is used primarily for surgical access to the posterior spine, if there is any significant lowering of the legs or tilt of the entire table, venous returns may be decrease or augmented accordingly. The purpose of this study was to examine the relationship between POCD and intra-operative cerebral oxygen saturation after spine surgery in elderly patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • the patient undergoing the lumbar spine surgery in severance hospital

排除标准

  • Patients who had previous cerebral disease, dementia, severe problems in hearing and understanding, or who were unable to provide informed consent were excluded.

研究组 & 干预措施

regional cerebral oxygen saturation

Experimental

干预措施: Neurologic and neuropsychologic tests (Other)

结局指标

主要结局

K-MMSE

时间窗: change of K-MMSE from baseine to 1 month

1. preoperative neuropsychological evaluation (the day before the surgery) 2. intraoperative rSO2 data monitoring 3-1. immediate postoperative neuropsychological evaluation (postoperative 4th\~7th day) 3-2. remote postoperative neuropsychological evaluation (postoperative 1month) 4\. Intraoperative

次要结局

  • visuomotor test(D-LOTCA battery)(measuring for visuomotor test during baseline and 1 month)
  • Regional cerebral oxymetry monitoring(measuring for Regional cerebral oxymetry monitoring during baseline and 1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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