search
Back to results

Postoperative Cognitive Dysfunction in Elderly (ElderlyPOCD)

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
battery neuropsychological tests
Sponsored by
Università degli Studi dell'Insubria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Cognitive Dysfunction focused on measuring 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

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale di Circolo e Fondazione MacchiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

General Anesthesia patients battery neuropsychological tests

Regular recovery patients

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
February 19, 2014
Last Updated
May 23, 2017
Sponsor
Università degli Studi dell'Insubria
search

1. Study Identification

Unique Protocol Identification Number
NCT02068742
Brief Title
Postoperative Cognitive Dysfunction in Elderly
Acronym
ElderlyPOCD
Official Title
Postoperative Cognitive Dysfunction in Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi dell'Insubria

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study has three specific aims: To define the frequency of occurrence of early post-operative cognitive dysfunction and its time course. To assess risk factors for the onset of post-operative cognitive dysfunction and possible causal factors. to compare our results with those from the international literature.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General Anesthesia patients battery neuropsychological tests
Arm Type
Experimental
Arm Description
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).
Arm Title
Regular recovery patients
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
battery neuropsychological tests
Other Intervention Name(s)
Mini Mental State Examination,, Geriatric Index of Comorbidity,, Geriatric Depression Scale,, Trail Making Test B-A,, Digit Span,, Digit Symbol Substitution Test
Intervention Description
Application of the scores will be on the day 0 (the day before the surgery), day 2 and day 4 (after the surgery).
Primary Outcome Measure Information:
Title
frequency of occurrence of post-operative cognitive dysfunction
Description
we apply specific neuropsychological tests find out post-operative cognitive dysfunction in elderly patients (number of patients 80)
Time Frame
about 90 days
Secondary Outcome Measure Information:
Title
assess risk factors and causal factors in the onset of post-operative cognitive dysfunction (number of patients 80)
Description
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
Time Frame
about 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Severgnini Paolo, MD, PhD
Phone
0039033278801
Email
paolo.severgnini@uninsubria.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Severgnini Paolo, MD, PhD
Organizational Affiliation
Università degli Studi dell'Insubria
Official's Role
Study Director
Facility Information:
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Severgnini, Professor
Phone
00390332278801
Email
paolo.severgnini@uninsubria.it
First Name & Middle Initial & Last Name & Degree
Paolo Severgnini, MD, PhD
First Name & Middle Initial & Last Name & Degree
Bellin Valeria, Student
First Name & Middle Initial & Last Name & Degree
Cattaneo Emanuele, Student
First Name & Middle Initial & Last Name & Degree
Manzolini Dario, MD

12. IPD Sharing Statement

Learn more about this trial

Postoperative Cognitive Dysfunction in Elderly

We'll reach out to this number within 24 hrs