Post Operative Cognitive Dysfunction (POCD)

February 2, 2023 updated by: FRANCISCO CARLOS BONOFIGLIO, Hospital Italiano de Buenos Aires

Impact of Anesthesia Surgical Procedure on the Development of Long-term Cognitive Dysfunction

The objective of this study will be to estimate the incidence of postoperative cognitive dysfunction (DCPO) in patients over 65 years of age, undergoing surgical / anesthetic procedures and in patients who will not undergo surgical / anesthetic. The patients will be taken from the Hospital Italiano de Buenos Aires.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective Study The objective of this study will be to estimate the incidence of Post Operative Cognitive Dysfunction (POCD) in patients over 65 years of age, undergoing surgical / anesthetic procedures and in patients who will not undergo surgical / anesthetic. The patients will be taken from the Hospital Italiano de Buenos Aires.

The population of the present study will be constituted by patients belonging to the HIBA Health Plan. It comprises patients who will not undergo any surgical / anesthetic act (Control Group) and those who will undergo sedation for diagnostic procedure or some surgical / anesthetic process (Exposure Group).

All patients will be tested, the day of signing the Informed Consent (IC), which will serve as an exclusion criterion.

Patients in the Exposure Group who signed the consent will be evaluated on five occasions: up to the day before the surgical / anesthetic act, on the day of the surgical / anesthetic event, 7 days (CAM - If the patient is hospitalized this test will do the test personally if the patient is discharged, the test will be done by telephone), 3 months later and a year after the procedure (for the latter two patients will be asked to attend the Hospital in time). Trained and trained personnel will be in charge of taking the test (which last approximately 1 hour). The battery of tests (detailed below) aims to determine if there is a cognitive decline, to estimate and compare it among the participants of this study.

Patients in the control group will be evaluated on 2 occasions only, a first evaluation on the day the patient and the researchers arrange and then, 12 months from that date.

Study Type

Interventional

Enrollment (Actual)

100

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 Locations

  • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina, 1181
        • Hospital Italiano de Buenos Aires

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:

or surgical / anesthetic and sedation.

  • Patients who have not been exposed in the last 12 months to any of the cases mentioned above.
  • Patients with scheduled surgeries will be included, both in the outpatient clinic and with requirements for hospitalization in the floor or in closed units (ICU, UC, etc.), and patients with diagnostic studies or therapeutic procedures requiring anesthesia for their performance by the other.
  • Patients will be included with absence of anesthetic or surgical / anesthetic act and sedation in the last 12 months.
  • Patients with complete primary schooling (6 years) will be included.

Exclusion Criteria:

  • Negative to participate or manage Informed Consent
  • MoCa (≤ 26)
  • Previous diagnosis of dementia
  • Psychosis
  • Depression. (GDS Yesavage> 5)

  • Toxic Substance abuse of Alcohol according to DSM4 Psychoactive Substances.

    • Use of Illicit drug

  • The presence of any congenital or acquired disease or injury that could generate cognitive deficit. (Whether psychiatric, neurological, or metabolic)
  • Previous neurosurgery.
  • Language barriers.
  • Decreased marked visual or auditory acuity that enable from performing the study tests.
  • Patients receiving antipsychotics, opioids, anticholinergics or patients who may have varied the benzodiazepines doze or other psychoactive drugs in the last 30 days.
  • Patient with cancer disease and life expectancy less than 1 year ( patients will be evaluated from the medical point of view from the records of clinical history according to tumor type, extent,etc.)
  • Patients undergoing emergency surgery.
  • Patients who have received anesthesia in the past 12 months

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: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control Group
It comprises patients who will not undergo any surgical / anesthetic act
OTHER: Exposure Group
It comprises those patients that will undergo sedation for diagnostic procedure or some surgical / anesthetic process
Other: Exposure Group
Surgeries of high or low impact. They could be local , regional o general anesthesia; sedation or a combination of both.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate the incidence of Post Operative Cognitive Dysfunction (POCD)
Time Frame: 1 year
We will measure the cognitive impairment using a battery of cognitive tests .
1 year
Estimate the incidence of Post Operative Cognitive Dysfunction (POCD)
Time Frame: 1 year
Check the differences at 12 months after starting the study.
1 year

Collaborators and Investigators

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

Sponsor

Hospital Italiano de Buenos Aires

Investigators

  • Principal Investigator: Francisco FB Bonofiglio, PHD, Hospital Italiano de Buenos Aires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

February 20, 2017

Primary Completion (ACTUAL)

February 5, 2018

Study Completion (ACTUAL)

March 1, 2022

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 24, 2017

First Posted (ACTUAL)

March 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2813

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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