- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02550626
Exploring the Relationship Between Alpha-synucleinopathy Related Non-motor Symptom and Post-op. Delirium in Elderly Patients With Spine Surgery
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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-
Seou
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Seoul, Seou, 대한민국, 120-752
- Department of Neurology, Yonsei University College of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
|---|
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Delirium
occurrence of post-operative delirium
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No delirium
no presence of post-operative delirium
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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existence of anosomia
기간: 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.).
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A day before operation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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existence of constipation
기간: A day before operation
|
Questionnaire (Constipation scoring system (Agachanet al., 1996) & Rome III Questionnaire (Constipation : Yes/No)
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A day before operation
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existence of orthostatic hypotension
기간: A day before operation
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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)
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A day before operation
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existence of insomnia
기간: A day before operation
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Questionnaire (Epworth Sleepiness Scale (ESS) : total score 0-24)
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A day before operation
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existence of depression
기간: A day before operation
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Questionnaire (Beck depression inventory, total score 0-63)
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A day before operation
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existence of anxiety
기간: A day before operation
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Questionnaire (The Parkinson Anxiety Scale, total score 0-48)
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A day before operation
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existence of REM sleep behavior disorder
기간: A day before operation
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Questionnaire (RBD screening questionnaire, total score 0-13) :These questionnaires & checking 3-position BP will not effect the occurence of post-operation delirium
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A day before operation
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .