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

Alpha-synucleinopathy Related Non-motor Symptom Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550626
• Other study ID #: 4-2015-0365
• Status: Completed
• Start date: October 2015
• Est. completion date: August 2016

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Age 65 and older patients

2. Scheduled to perform spine surgery in severance hospital

Exclusion Criteria:

1. Previous delirium history

2. Previous chemotherapy or radiotherapy within 1yr due to underlying cancer.

3. Severe hepatic/renal dysfunction

Related Conditions & MeSH terms

• Alpha-synucleinopathy Related Non-motor Symptom
• Delirium
• Post-operation Delirium

Locations

Country	Name	City	State
Korea, Republic of	Department of Neurology, Yonsei University College of Medicine	Seoul	Seou

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.).	A day before operation
Secondary	existence of constipation	Questionnaire (Constipation scoring system (Agachanet al., 1996) & Rome III Questionnaire (Constipation : Yes/No)	A day before operation
Secondary	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)	A day before operation
Secondary	existence of insomnia	Questionnaire (Epworth Sleepiness Scale (ESS) : total score 0-24)	A day before operation
Secondary	existence of depression	Questionnaire (Beck depression inventory, total score 0-63)	A day before operation
Secondary	existence of anxiety	Questionnaire (The Parkinson Anxiety Scale, total score 0-48)	A day before operation
Secondary	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	A day before operation