The Effects of Anesthesia Depth Monitoring on Postoperative Recovery and Cognitive Functions in the Geriatric Patient Population

ConditionsGeriatric Patient Care Improvement Postoperative Delirium (POD)Burst Suppression

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age65+

SponsorAslıhan Güleç

About this trial

This study will be conducted on patients aged 65 and older scheduled for surgery due to lumbar or cervical disc herniation. General anesthesia is routinely used for these types of surgeries in the hospital. In patients receiving general anesthesia, anesthesia depth monitoring is performed.

As part of the study, a preoperative anesthesia evaluation will be conducted, which will include age, weight, height, comorbidities, regularly used medications, previous surgical or anesthesia experiences, nutritional habits, mental status, and daily activity levels.

On the day of surgery, upon arrival in the operating room, the following will be measured and recorded:

* Blood pressure using a non-invasive blood pressure monitor * Heart rate and rhythm via electrocardiogram (ECG) * Blood oxygen level with a pulse oximeter * Anesthesia depth using a forehead-applied sensor

All monitoring procedures are non-invasive and painless. Following the placement of these monitoring devices and initial measurements, anesthesia induction and surgery will commence. Throughout surgery, blood pressure, heart rate, and brain activity will be continuously recorded. After the surgical procedure, anesthesia emergence and mental status will be assessed. Preoperative evaluation data and intraoperative recordings will be used solely for research purposes, with patient identity information remaining confidential.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

65 years and older

Elective spinal surgeries

ASA status I-III

Disqualifiers

Emergent surgeries

ASA status IV-V

Prediagnosed delirium and or dementia

Inability to give consent

Trial design

Design model

Parallel

Treatments tested in this trial

Control Group: Standard Hemodynamic Monitoring
Other intervention
Anesthesia depth monitoring based on hemodynamic values without additional processed EEG guidance.
Processed Electroencephalogram (BIS Index)
Device
Anaesthesia depth monitoring according to numeric BIS index values.
Processed Electroencephalogram (DSA Mode)
Device
Anaesthesia depth monitoring according to density spectral array functions

Treatment groups

75 Participants

are divided into 3 treatment groups

Group A: Hemodynamic-Guided GroupActive comparator 1 intervention

Group B: BIS-Guided GroupActive comparator 1 intervention

Group C: DSA-Guided GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Ratio of Burst Suppression

The burst suppression ratio (BSR) will be calculated as the percentage of total anesthesia time spent in burst suppression, as measured by processed electroencephalography (EEG). A higher BSR has been associated with worse postoperative cognitive outcomes.

Time frame

Intraoperative (continuously recorded from anesthesia induction to emergence)

Time of Burst Suppression

Anesthesia time spent in burst suppression (BS), as measured by processed electroencephalography (EEG). A higher BS time has been associated with worse postoperative cognitive outcomes.

Time frame

Intraoperative (continuously recorded from anesthesia induction to emergence)

Intraoperative Hypotension Incidence

Intraoperative hypotension will be measured in 5-minute intervals. Hypotension is a mean arterial pressure (MAP) below 60 mmHg. The episodes of hypotension at any point during surgery will be recorded.

Time frame

Intraoperative (assessed continuously throughout surgery)

Alpha Band Preservation or Loss

Alpha band activity (8-12 Hz) in the frontal lobe will be evaluated to determine whether it is preserved or lost during general anesthesia. Alpha band preservation is associated with optimal anesthesia depth and cognitive function preservation, while loss of alpha band activity is linked to increased postoperative cognitive impairment.

Time frame

Intraoperative (measured continuously from anesthesia induction to emergence)

Secondary outcomes

Incidence of Postoperative Delirium Assessed via CAM Scale

Postoperative delirium will be assessed using the Confusion Assessment Method (CAM) tool. The number of participants meeting the criteria for delirium within the first 48 hours postoperatively will be recorded.

Time frame

Postoperative (assessed at 6, 24, and 48 hours after surgery)

Total Intraoperative Propofol Consumption

The total dose of propofol administered intraoperatively will be recorded. Data will be reported as mg/kg.

Time frame

Intraoperative

Total Intraoperative Sevoflurane Consumption

The total dose of Sevoflurane administered intraoperatively will be recorded. Data will be reported as ml.

Time frame

Intraoperative

Total Intraoperative Remifentanil Consumption

The total dose of Remifentanil administered intraoperatively will be recorded. Data will be reported as mcg/kg.

Time frame

Intraoperative

Other outcomes

Frailty Score Assessed via Clinical Frailty Scale (CFS)

Frailty will be assessed preoperatively using the Clinical Frailty Scale (CFS), which ranges from 1 (very fit) to 9 (terminally ill). Higher scores indicate worse frailty status. The proportion of participants classified as frail (CFS ≥ 5) will be reported.

Time frame

Preoperative (assessed on the day of surgery)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aslıhan Güleç

Lead sponsor

Gazi University

Sponsor institution

Source ClinicalTrials.gov

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