Postoperative Cognitive Dysfunction in Elderly (ElderlyPOCD)

May 23, 2017 updated by: Paolo Severgnini, Università degli Studi dell'Insubria

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.

Study Overview

Status

Unknown

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Varese, Italy, 21100
        • Recruiting
        • Ospedale Di Circolo E Fondazione Macchi
        • Contact:
        • Principal Investigator:
          • Paolo Severgnini, MD, PhD
        • Sub-Investigator:
          • Bellin Valeria, Student
        • Sub-Investigator:
          • Cattaneo Emanuele, Student
        • Sub-Investigator:
          • Manzolini Dario, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: General Anesthesia patients battery neuropsychological tests
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).
Application of the scores will be on the day 0 (the day before the surgery), day 2 and day 4 (after the surgery).
Other Names:
  • Mini Mental State Examination,
  • Geriatric Index of Comorbidity,
  • Geriatric Depression Scale,
  • Trail Making Test B-A,
  • Digit Span,
  • Digit Symbol Substitution Test
Active Comparator: Regular recovery patients
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).
Application of the scores will be on the day 0 (the day before the surgery), day 2 and day 4 (after the surgery).
Other Names:
  • Mini Mental State Examination,
  • Geriatric Index of Comorbidity,
  • Geriatric Depression Scale,
  • Trail Making Test B-A,
  • Digit Span,
  • Digit Symbol Substitution Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of occurrence of post-operative cognitive dysfunction
Time Frame: about 90 days
we apply specific neuropsychological tests find out post-operative cognitive dysfunction in elderly patients (number of patients 80)
about 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess risk factors and causal factors in the onset of post-operative cognitive dysfunction (number of patients 80)
Time Frame: about 90 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Severgnini Paolo, MD, PhD, Università degli Studi dell'Insubria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

February 19, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 21, 2014

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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