Clinical Trials Directory

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UnknownNCT02068742

Postoperative Cognitive Dysfunction in Elderly

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
160 (estimated)
Sponsor
Università degli Studi dell'Insubria · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERbattery neuropsychological testsApplication of the scores will be on the day 0 (the day before the surgery), day 2 and day 4 (after the surgery).

Timeline

Start date
2014-01-01
Primary completion
2017-05-01
Completion
2018-01-01
First posted
2014-02-21
Last updated
2017-05-25

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT02068742. Inclusion in this directory is not an endorsement.