- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02068742
Postoperative Cognitive Dysfunction in Elderly (ElderlyPOCD)
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
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Severgnini Paolo, MD, PhD
- Phone Number: 0039033278801
- Email: paolo.severgnini@uninsubria.it
Study Locations
-
-
-
Varese, Italy, 21100
- Recruiting
- Ospedale Di Circolo E Fondazione Macchi
-
Contact:
- Paolo Severgnini, Professor
- Phone Number: 00390332278801
- Email: paolo.severgnini@uninsubria.it
-
Principal Investigator:
- Paolo Severgnini, MD, PhD
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Sub-Investigator:
- Bellin Valeria, Student
-
Sub-Investigator:
- Cattaneo Emanuele, Student
-
Sub-Investigator:
- Manzolini Dario, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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
Investigators
- Study Director: Severgnini Paolo, MD, PhD, Università degli Studi dell'Insubria
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1048
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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