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

Completed

• Conditions: Alpha-synucleinopathy Related Non-motor Symptom; Post-operation Delirium

• Registration Number: NCT02550626
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-15
• Study Start: 2015-10
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
existence of anosomia	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.).

Secondary Outcome Measures

Name	Time	Method
existence of orthostatic hypotension	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)
existence of anxiety	A day before operation	Questionnaire (The Parkinson Anxiety Scale, total score 0-48)
existence of REM sleep behavior disorder	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
existence of constipation	A day before operation	Questionnaire (Constipation scoring system (Agachanet al., 1996) \& Rome III Questionnaire (Constipation : Yes/No)
existence of insomnia	A day before operation	Questionnaire (Epworth Sleepiness Scale (ESS) : total score 0-24)
existence of depression	A day before operation	Questionnaire (Beck depression inventory, total score 0-63)

Trial Locations

Locations (1)

Department of Neurology, Yonsei University College of Medicine; 🇰🇷 Seoul, Seou, Korea, Republic of