Postoperative Cognitive Dysfunction in Heart Surgery

June 8, 2022 updated by: Huri Yeşildal, Kocaeli University

Postoperative Cognitive Dysfunction in Participants Undergoing Open Heart Surgery

To determine the rate of Postoperative Cognitive Dysfunction (POCD) in the early and late postoperative periods by comparing the preop and postop period mini mental status tests in participants undergoing open heart surgery, and to compare the results of the investgators clinic with the world literature.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postoperative delirium (POD) and Cognitive Dysfunction (POCD) are changes in mental status, especially in the geriatric surgery population.Unlike other forms of delirium, POD results in early full recovery.Postoperative Cognitive Dysfunction (POCD) is more difficult to define and implies temporal consciousness impairment associated with surgery.

While the diagnosis of delirium requires the detection of symptoms, the diagnosis of POCD requires preoperative neuropsychological testing and determining how much reduction will mean cognitive dysfunction. Postoperative delirium management is complex and requires multiple strategies. Methods of treating and preventing POCD are still uncertain.It is known that POCD is most commonly seen in patients undergoing open heart surgery.In this study, the investigators aim is to evaluate whether there is any change in cognitive status in the postoperative period compared to the preoperative period of participants who will undergo open heart surgery due to valve pathology or coronary stenosis.

Study Type

Observational

Enrollment (Actual)

140

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

  • Turkey
    • İzmit
      • Kocaeli, İzmit, Turkey, 41100
        • Kocaeli Üniversitesi Tıp Fakültesi Hastanesi

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

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A study was planned on 140 patients undergoing open heart surgery.

Description

Inclusion Criteria:

  • 18-75 age
  • American Society of Anesthesiologists (ASA) II-III

Exclusion Criteria:

  • >75 age
  • <18 age
  • Patients who died within 48 hours after the operation

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

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Preoperative cognitive status of participants undergoing open heart surgery

Detection of postoperative cognitive impairment is difficult and it starts with testing in the preoperative period.

In this study, it was aimed to determine postoperative cognitive impairment by comparing cognitive functions by using Minimental status test in the preoperative period in participants scheduled for open heart surgery for one year. It was planned to compare the obtained data in terms of participants undergoing valve and coronary bypass surgery, age, gender, diabetes, kidney disease, chronic obstructive pulmonary disease (COPD), surgical characteristics, bypass time, and crossclamping time.
Other: Preoperative cognitive functions of participants undergoing open heart surgery
Surgery times and cross-clamping times of the participants who will undergo open heart surgery were recorded.
Postoperative cognitive status of participants undergoing open heart surgery
Detection of postoperative cognitive impairment is difficult and it starts with testing in the preoperative period. In this study, it was aimed to determine the postoperative cognitive impairment by comparing it with the cognitive functions in the preoperative period using the Minimental status test in the postoperative period in participants scheduled for open heart surgery for a year. It was planned to compare the obtained data in terms of participants undergoing valve and coronary bypass surgery, age, gender, diabetes, kidney disease, chronic obstructive pulmonary disease (COPD), surgical characteristics, bypass time, and crossclamping time.
Other: Postoperative cognitive functions of particiants undergoing open heart surgery
Changes in mini mental test scores were recorded in the postoperative period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of postoperative cognitive functions in participants undergoing open heart surgery.
Time Frame: 1 year
The aim is to understand whether there is a loss of cognitive functions in the postoperative period, according to the preoperative periods, by testing the participants with open heart surgery on the 3rd day, 7th day, and 2nd month after the surgery.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison with the literature.
Time Frame: 1 year
Comparison of the results in the investigators clinic with the literature.
1 year

Collaborators and Investigators

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

Sponsor

Kocaeli University

Investigators

  • Study Director: Tülay Çardaközü, Kocaeli University

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)

January 1, 2020

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

June 1, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Observational

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all collected individual participant data

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

The study results can be accessed by anyone who is a healthcare worker.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

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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