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Exploring the Relationship Between Alpha-synucleinopathy Related Non-motor Symptom and Post-op. Delirium in Elderly Patients With Spine Surgery

2019年2月14日更新者：Yonsei University

Hypothesis is that the presence of a-synucleinopathy related non motor symptoms could be predictive factor for post-operative delirium. During 72hrs after spine surgery, investigator will observe occurrence of post-operative delirium, and analysis difference of a-synucleinopathy related non motor symptoms between 2 groups.

研究概览

地位

完全的

条件

详细说明

Postoperative delirium appear approximately 10-70% of patients older than 65 yrs undergoing surgery and it is strongly associated with poor surgical outcome. The clinical characteristics of postoperative delirium are fluctuating attention, visual hallucination, disorganized thought and alter sleep-wake cycles. This is quite similar to core features of α-synuclein-related cognitive disorders such as parkinson's disease dementia and dementia with lewy body. At that point, investigator thought that postoperative delirium is preclinical stage of a-synucleinopathy. In other words, a-synuclein related disorders and postoperative delirium may share an underlying neurochemical change in their pathogenesis.

investigator will recruit age 65 and older patients scheduled to perform spine surgery. The pre-operative evaluation include neurologic exam, baseline cognitive function and a-synucleinopathy related non motor symptoms through Questionnaires.

研究类型

观察性的

注册 (实际的)

106

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

大韩民国
- Seou
  - Seoul、Seou、大韩民国、120-752
    - Department of Neurology, Yonsei University College of Medicine

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年及以上 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

spine surgery

描述

Inclusion Criteria:

Age 65 and older patients
Scheduled to perform spine surgery in severance hospital

Exclusion Criteria:

Previous delirium history
Previous chemotherapy or radiotherapy within 1yr due to underlying cancer.
Severe hepatic/renal dysfunction

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：病例对照
时间观点：预期

团体/队列数

队列和干预

团体/队列
Delirium occurrence of post-operative delirium
No delirium no presence of post-operative delirium

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
existence of anosomia 大体时间：A day before operation	During 72hrs after spine surgery, investigator will observe occurrence of post-operative delirium, and analysis difference of anosmia symptoms before operation between 2 groups. The cross-cultural smell identification test will be used for measure of anosmia. investigator define anosmia as less than 4 score on the cross-cultural smell identification test. This study is not interventional study, because measure of anosmia by smell kit will not develop post-operation delirium more. (investigator will classify our patients into normosmia if the CCSIT score is 9 or higher, and hyposmia if the CCSIT score is 6 or less. Patients whose CCSIT scores are 7 or 8 will be regarded as borderline.).	A day before operation

次要结果测量

结果测量	措施说明	大体时间
existence of constipation 大体时间：A day before operation	Questionnaire (Constipation scoring system (Agachanet al., 1996) & Rome III Questionnaire (Constipation : Yes/No)	A day before operation
existence of orthostatic hypotension 大体时间：A day before operation	Check 3 position BP (define orthostatic hypotension - sustained reduction of systolic blood pressure of at least 20 mmHg or diastolic blood pressure of 10 mmHg within 3 min of standing, / Questionnaire (orthostatic hypotension symptom assessment & Orthostatic hypotension daily activities scale) (orthostatic hypotension: Yes/No)	A day before operation
existence of insomnia 大体时间：A day before operation	Questionnaire (Epworth Sleepiness Scale (ESS) : total score 0-24)	A day before operation
existence of depression 大体时间：A day before operation	Questionnaire (Beck depression inventory, total score 0-63)	A day before operation
existence of anxiety 大体时间：A day before operation	Questionnaire (The Parkinson Anxiety Scale, total score 0-48)	A day before operation
existence of REM sleep behavior disorder 大体时间：A day before operation	Questionnaire (RBD screening questionnaire, total score 0-13) :These questionnaires & checking 3-position BP will not effect the occurence of post-operation delirium	A day before operation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Yonsei University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年10月1日

初级完成 (实际的)

2016年8月1日

研究完成 (实际的)

2016年8月1日

研究注册日期

首次提交

2015年7月16日

首先提交符合 QC 标准的

2015年9月14日

首次发布 (估计)

2015年9月15日

研究记录更新

最后更新发布 (实际的)

2019年2月15日

上次提交的符合 QC 标准的更新

2019年2月14日

最后验证

2019年2月1日