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Postoperative Cognitive Dysfunction in Elderly

Postoperative Cognitive Dysfunction in Elderly

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02068742
Acronym
ElderlyPOCD
Enrollment
160
Registered
2014-02-21
Start date
2014-01-31
Completion date
2018-01-31
Last updated
2017-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cognitive Dysfunction

Keywords

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

Brief summary

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

This study has three specific aims: 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.

Interventions

OTHERbattery 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).

Sponsors

Università degli Studi dell'Insubria
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
frequency of occurrence of post-operative cognitive dysfunctionabout 90 dayswe apply specific neuropsychological tests find out post-operative cognitive dysfunction in elderly patients (number of patients 80)

Secondary

MeasureTime frameDescription
assess risk factors and causal factors in the onset of post-operative cognitive dysfunction (number of patients 80)about 90 dayswe 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

Countries

Italy

Contacts

Primary ContactSevergnini Paolo, MD, PhD
paolo.severgnini@uninsubria.it0039033278801

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026