Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2014-01-31
2018-01-31
Brief Summary
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The main purpose of this study is to determine the incidence of early postoperative cognitive dysfunction in elderly patients and its time course.
This study will first evaluate the preoperative cognitive function of elderly patients based on several criteria including complete patient history, laboratory and instrumental exams, and the following measures in order to identify conditions and pathologies that may influence cognitive function.
* Mini Mental State Examination
* Geriatric Index of Comorbidity
* Geriatric Depression Scale
The following neuropsychological tests will be performed on the same day within 7 days of surgery (baseline):
* Trail Making Test B-A
* Digit Span
* Digit Symbol Substitution Test
The three cognitive function assessments will be repeated at the following postoperative time points and the change from the preoperative baseline to each time will be evaluated:
* Day 2 (time point 1)
* Day 4 (time point 2)
* Between days 85 and 90 (time point 3)
If the patient seems confused before the postoperative administration of these tests, the Neecham Confusion Scale will be used to evaluate the patient for the presence of postoperative delirium; if delirium is not detected, the cognitive function tests will be administered.
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Detailed Description
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1. To define the frequency of occurrence of early post-operative cognitive dysfunction and its time course.
2. To assess risk factors for the onset of post-operative cognitive dysfunction and possible causal factors.
3. to compare our results with those from the international literature.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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General Anesthesia patients battery neuropsychological tests
Mini Mental State Examination, Geriatric Index of Comorbidity, Geriatric Depression Scale, Trail Making Test B-A, Digit Span, Digit Symbol Substitution Test Application of the scores will be on the day 0 (the day before the surgery), day 2 and day 4 (after the surgery).
battery neuropsychological tests
Application of the scores will be on the day 0 (the day before the surgery), day 2 and day 4 (after the surgery).
Regular recovery patients
Mini Mental State Examination, Geriatric Index of Comorbidity, Geriatric Depression Scale, Trail Making Test B-A, Digit Span, Digit Symbol Substitution Test Application of the scores will be on the day 0 (the day after the hospital admission), day 2 and day 4 (days after the hospital admission).
battery neuropsychological tests
Application of the scores will be on the day 0 (the day before the surgery), day 2 and day 4 (after the surgery).
Interventions
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battery neuropsychological tests
Application of the scores will be on the day 0 (the day before the surgery), day 2 and day 4 (after the surgery).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Surgery scheduled under general anesthesia, that is expected to last 90 minutes or longer for the arm experimental
Exclusion Criteria
* Illiteracy
* Can't understand Italian language
* Serious hearing or vision impairment not treatable
* A history of any disease of the central nervous system
* A current or past history of psychiatric illness
* A current use of major tranquilizers or antidepressants
* alcoholism or drug dependence or abuse
* Scheduled to undergo cardiac, carotid or intracranial procedures
* Not expected to be alive or available to complete testing at 90 days after surgery
65 Years
ALL
No
Sponsors
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Università degli Studi dell'Insubria
OTHER
Responsible Party
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Paolo Severgnini
MD, PhD
Principal Investigators
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Severgnini Paolo, MD, PhD
Role: STUDY_DIRECTOR
Università degli Studi dell'Insubria
Locations
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Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1048
Identifier Type: -
Identifier Source: org_study_id
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