Postoperative Cognitive Dysfunction in Elderly

Postoperative Cognitive Dysfunction Clinical Trial

— ElderlyPOCD  

Official title:

Postoperative Cognitive Dysfunction in Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02068742
• Other study ID #: 1048
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2014
• Last updated: May 23, 2017
• Start date: January 2014
• Est. completion date: January 2018

Study information

• Verified date: May 2017
• Source: Università degli Studi dell'Insubria
• Contact: Severgnini Paolo, MD, PhD
• Phone: 0039033278801
• Email: paolo.severgnini[@]uninsubria.it
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Postoperative Cognitive Dysfunction

Intervention

Other:
• battery 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).

Locations

Country	Name	City	State
Italy	Ospedale di Circolo e Fondazione Macchi	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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