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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seou
    • Seoul, Seou, Korea, Republic of, 120-752
      • Department of Neurology, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

spine surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Delirium; occurrence of post-operative delirium
No delirium; no presence of post-operative delirium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: July 16, 2015
• First Submitted That Met QC Criteria: September 14, 2015
• First Posted (Estimate): September 15, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: delirium; spine surgery; alpha synucleinopathy
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Proteostasis Deficiencies; Delirium; Synucleinopathies
• Other Study ID Numbers: 4-2015-0365