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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05406843
Other study ID # Observational
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date August 1, 2021

Study information

Verified date June 2022
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date August 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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 functions of particiants undergoing open heart surgery
Changes in mini mental test scores were recorded in the postoperative period.

Locations

Country Name City State
Turkey Kocaeli Üniversitesi Tip Fakültesi Hastanesi Kocaeli Izmit

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of postoperative cognitive functions in participants undergoing open heart surgery. 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 Comparison with the literature. Comparison of the results in the investigators clinic with the literature. 1 year
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