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

NCT06644209 | Completed

• 1 other identifier: AU-BY-001
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Delirium; Cognitive Impairment

Keywords

Bispectral Index; Median Frequency; Spectral Edge Frequency; Post Operative Cognitive Dysfunction; Cognition

Outcome Measures

Primary Outcomes (2)

• Nu-DESC Score

  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

  Increase in 4AT score compared to baseline test, or a postoperative 4AT score greater than or equal to 4

  3 Days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, Altindag, Turkey (Türkiye)

Location

Related Publications (1)

• Koch S, Windmann V, Chakravarty S, Kruppa J, Yurek F, Brown EN, Winterer G, Spies C; BioCog Study Group. Perioperative Electroencephalogram Spectral Dynamics Related to Postoperative Delirium in Older Patients. Anesth Analg. 2021 Dec 1;133(6):1598-1607. doi: 10.1213/ANE.0000000000005668.

  PMID: 34591807 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: January 25, 2024
• Primary Completion: June 25, 2024
• Study Completion: July 25, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)