- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02550626
Exploring the Relationship Between Alpha-synucleinopathy Related Non-motor Symptom and Post-op. Delirium in Elderly Patients With Spine Surgery
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Seou
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Seoul, Seou, Corée, République de, 120-752
- Department of Neurology, Yonsei University College of Medicine
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-témoins
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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existence of anosomia
Délai: A day before operation
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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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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existence of constipation
Délai: A day before operation
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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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 4-2015-0365
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