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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.
The following neuropsychological tests will be performed on the same day within 7 days of surgery (baseline):
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:
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.
This study has three specific aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Anesthesia patients battery neuropsychological tests | Experimental | 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). |
|
| Regular recovery patients | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| battery neuropsychological tests | Other | Application of the scores will be on the day 0 (the day before the surgery), day 2 and day 4 (after the surgery). |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Severgnini Paolo, MD, PhD | Contact | 0039033278801 | paolo.severgnini@uninsubria.it |
| Name | Affiliation | Role |
|---|---|---|
| Severgnini Paolo, MD, PhD | Università degli Studi dell'Insubria | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale di Circolo e Fondazione Macchi | Recruiting | Varese | 21100 | Italy |
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| ID | Term |
|---|---|
| D000079690 | Postoperative Cognitive Complications |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
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| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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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.
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|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |