An observational study in Post-operation Delirium and Alpha-synucleinopathy Related Non-motor Symptom, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by Yonsei University · Observational
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.
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.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's enrollment of 106 is below the median of 194 across 342 observational studies indexed under Delirium.
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spine surgery
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Exclusion Criteria:
occurrence of post-operative delirium
no presence of post-operative delirium
existence of anosomia
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.).
Time frame: A day before operation
existence of constipation
Questionnaire (Constipation scoring system (Agachanet al., 1996) \& Rome III Questionnaire (Constipation : Yes/No)
Time frame: A day before operation
existence of orthostatic hypotension
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)
Time frame: A day before operation
existence of insomnia
Questionnaire (Epworth Sleepiness Scale (ESS) : total score 0-24)
Time frame: A day before operation
existence of depression
Questionnaire (Beck depression inventory, total score 0-63)
Time frame: A day before operation
existence of anxiety
Questionnaire (The Parkinson Anxiety Scale, total score 0-48)
Time frame: A day before operation
existence of REM sleep behavior disorder
Questionnaire (RBD screening questionnaire, total score 0-13) :These questionnaires \& checking 3-position BP will not effect the occurence of post-operation delirium
Time frame: A day before operation
The record gives a start of Oct 2015, a primary completion of Aug 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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