- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02550626
Exploring the Relationship Between Alpha-synucleinopathy Related Non-motor Symptom and Post-op. Delirium in Elderly Patients With Spine Surgery
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Seou
-
Seoul, Seou, Korea, Republiken av, 120-752
- Department of Neurology, Yonsei University College of Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Control
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
|---|
|
Delirium
occurrence of post-operative delirium
|
|
No delirium
no presence of post-operative delirium
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
existence of anosomia
Tidsram: 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.).
|
A day before operation
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
existence of constipation
Tidsram: A day before operation
|
Questionnaire (Constipation scoring system (Agachanet al., 1996) & Rome III Questionnaire (Constipation : Yes/No)
|
A day before operation
|
|
existence of orthostatic hypotension
Tidsram: 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)
|
A day before operation
|
|
existence of insomnia
Tidsram: A day before operation
|
Questionnaire (Epworth Sleepiness Scale (ESS) : total score 0-24)
|
A day before operation
|
|
existence of depression
Tidsram: A day before operation
|
Questionnaire (Beck depression inventory, total score 0-63)
|
A day before operation
|
|
existence of anxiety
Tidsram: A day before operation
|
Questionnaire (The Parkinson Anxiety Scale, total score 0-48)
|
A day before operation
|
|
existence of REM sleep behavior disorder
Tidsram: 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
|
A day before operation
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 4-2015-0365
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .