Postoperative Cognitive Dysfunction in Elderly

NCT02068742 | Unknown DMC

• 1 other identifier: 1048
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• assess risk factors and causal factors in the onset of post-operative cognitive dysfunction (number of patients 80)

  about 90 days

Study Arms (2)

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).

Other: battery neuropsychological tests

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).

Other: battery neuropsychological tests

Interventions

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).

Also known as: Mini Mental State Examination,, Geriatric Index of Comorbidity,, Geriatric Depression Scale,, Trail Making Test B-A,, Digit Span,, Digit Symbol Substitution Test

General Anesthesia patients battery neuropsychological tests; Regular recovery patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \> 65 years
• Surgery scheduled under general anesthesia, that is expected to last 90 minutes or longer for the arm experimental

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

RECRUITING

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Severgnini Paolo, MD, PhD

  Università degli Studi dell'Insubria

  STUDY DIRECTOR

Central Study Contacts

Severgnini Paolo, MD, PhD

CONTACT

0039033278801; paolo.severgnini@uninsubria.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 21, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: January 1, 2018
• Last Updated: May 25, 2017

Record last verified: 2017-05

Locations

IT (1)