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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06644209

Enrollment

Registered

2024-10-16

Start date

2024-01-25

Completion date

2024-07-25

Last updated

2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Postoperative Delirium

Keywords

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

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Turkey (Türkiye)

Outcome results