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Completed

NCT Number: NCT02550626

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.

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Key information

Conditions

Post-operation Delirium Alpha-synucleinopathy Related Non-motor Symptom Confusion Delirium Mental Disorders Metabolic Diseases Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Signs and Symptoms Synucleinopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, Yonsei University College of Medicine

Seoul, Seou, 120-752, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. existence of anosomia

    Time frame: 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 outcomes

  1. existence of constipation

    Time frame: A day before operation

    Questionnaire (Constipation scoring system (Agachanet al., 1996) & Rome III Questionnaire (Constipation : Yes/No)

  2. existence of orthostatic hypotension

    Time frame: 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)

  3. existence of insomnia

    Time frame: A day before operation

    Questionnaire (Epworth Sleepiness Scale (ESS) : total score 0-24)

  4. existence of depression

    Time frame: A day before operation

    Questionnaire (Beck depression inventory, total score 0-63)

  5. existence of anxiety

    Time frame: A day before operation

    Questionnaire (The Parkinson Anxiety Scale, total score 0-48)

  6. existence of REM sleep behavior disorder

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2015
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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