Postoperative Cognitive Dysfunction in Elderly

Study Overview
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Brief Summary
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Interventional Study of Early Postoperative Cognitive Dysfunction in Elderly Patients Undergoing General Anesthesia 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.

Detailed Description
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This study has three specific aims: To define the frequency of occurrence of early post-operative cognitive dysfunction and its time course. To assess risk factors for the onset of post-operative cognitive dysfunction and possible causal factors. to compare our results with those from the international literature.

Official Title
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Postoperative Cognitive Dysfunction in Elderly

Conditions
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Postoperative Cognitive Dysfunction

Intervention / Treatment
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* Other: battery neuropsychological tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 65 years Surgery scheduled under general anesthesia, that is expected to last 90 minutes or longer for the arm experimental Exclusion Criteria: A score of 20 or less on the Mini-Mental State Examination (MMSE) 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: First arm of the study considers patients from the operating room with general anesthesia; Second arm of the study considers patients from geriatric regular general ward, without any anesthesia.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: General Anesthesia patients battery neuropsychological tests<br>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). | Other: battery neuropsychological tests<br>* Application of the scores will be on the day 0 (the day before the surgery), day 2 and day 4 (after the surgery).<br>* Other names: Digit Symbol Substitution Test;|
| Active Comparator: Regular recovery patients<br>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). | Other: battery neuropsychological tests<br>* Application of the scores will be on the day 0 (the day before the surgery), day 2 and day 4 (after the surgery).<br>* Other names: Digit Symbol Substitution Test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of occurrence of post-operative cognitive dysfunction | we apply specific neuropsychological tests find out post-operative cognitive dysfunction in elderly patients (number of patients 80) | about 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess risk factors and causal factors in the onset of post-operative cognitive dysfunction (number of patients 80) | we look for possible risk factors or causal factors in the onset of post-operative cognitive dysfunction considering comorbidity of patients and specific events occurred during anesthesia | about 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-operative cognitive dysfunction, elderly, Mini Mental State Examination, Geriatric Index of Comorbidity, Geriatric Depression Scale, Trail Making Test B-A, Digit Span, Digit Symbol Substitution Test