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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02068742
Study type Interventional
Source Università degli Studi dell'Insubria
Contact Severgnini Paolo, MD, PhD
Phone 0039033278801
Email paolo.severgnini@uninsubria.it
Status Recruiting
Phase N/A
Start date January 2014
Completion date January 2018

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