Predictive Efficacy of Ratio of Median Frequency to Spectral Edge Frequency Used in the Depth of Anaesthesia Monitoring on Post-operative Cognitive Functions

October 14, 2024 updated by: Basak Ceyda MECO, Ankara University

The primary objective of this observational study is to evaluate the effectiveness of preoperative anaesthesia depth monitoring parameters in predicting postoperative cognitive functions in non-cardiac adult patients.

Participants will preoperatively perform cognitive tests such as the Nursing Delirium Screening Scale(Nu-DESC) and 4 'A's Test(4AT) to assess baseline cognitive performance. The same tests will be repeated twice daily until the postoperative 3rd day or discharge.

Study Overview

Status

Completed

Conditions

Detailed Description

The primary objective of this observational study is to evaluate the effectiveness of preoperative anaesthesia depth monitoring parameters such as Bispectral Index(BIS), Spectral edge frequency(SEF) and Median frequency(MF) in predicting postoperative cognitive functions in non-cardiac adult patients.

Participants will preoperatively perform cognitive tests such as the Nursing Delirium Screening Scale(Nu-DESC) and 4 'A's Test(4AT) to assess baseline cognitive performance. Intraoperative haemodynamic and BIS parameters will be collected via manual data entry into printed forms. Also, a two-channel electroencephalogram(EEG) and BIS parameters(BIS Number, SEF, MF) will be collected digitally.

The cognitive tests will be repeated twice daily until the postoperative 3rd day or discharge.

Parameters such as mean intraoperative MF value and the ratio of MF over SEF will be compared against postoperative cognitive test scores.

Study Type

Observational

Enrollment (Actual)

67

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
    • Altindag
      • Ankara, Altindag, Turkey
        • Ankara University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The research focuses on adults (≥18 years old) of any gender residing in Türkiye, scheduled for elective, non-cardiac surgeries.

Description

Inclusion Criteria:

Adult patients (aged over 18 years), Patients undergoing elective surgeries, Patients consenting to participate in the study.

Exclusion Criteria:

Pediatric patients (aged under 18 years), Patients undergoing emergency surgeries, Patients requiring or anticipated to require postoperative intensive care for more than one day, Patients undergoing cardiac surgeries, Patients undergoing intracranial surgeries, Patients are undergoing endoscopic sinus or brain surgeries, Patients with pacemakers or implantable cardioverter-defibrillators (ICDs), Patients diagnosed with dementia (including Alzheimer's disease, Lewy body dementia, etc.), Patients with chronic opioid or benzodiazepine use, Patients with contraindications to Propofol, Remifentanil, or Fentanyl, Pregnant or breastfeeding women, Patients are not willing to participate in the study.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nu-DESC Score
Time Frame: 3 Days
Increase in Nu-DESC score compared to baseline test, or a postoperative Nu-DESC score greater than or equal to 2
3 Days
4AT Score
Time Frame: 3 Days
Increase in 4AT score compared to baseline test, or a postoperative 4AT score greater than or equal to 4
3 Days

Collaborators and Investigators

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

Sponsor

Ankara University

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)

January 25, 2024

Primary Completion (Actual)

June 25, 2024

Study Completion (Actual)

July 25, 2024

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 14, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-BY-001

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

product manufactured in and exported from the U.S.

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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