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

Aslıhan Güleç

Status: Enrolling

Conditions: Postoperative Delirium (POD); Geriatric Patient Care Improvement; Burst Suppression

Treatments: Device: Processed Electroencephalogram (BIS Index); Device: Processed Electroencephalogram (DSA Mode); Other: Control Group: Standard Hemodynamic Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06844279

Gazi-2024 -1816

Details and patient eligibility

About

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.

Full description

Perioperative cognitive decline and delirium occur more frequently in the geriatric population undergoing surgery. International guidelines recommend monitoring anesthesia depth to reduce the risk of postoperative cognitive dysfunction. Anesthesia depth is commonly measured using non-invasive electroencephalography (EEG)-based methods, such as the Bispectral Index (BIS).

Previous studies have predominantly utilized processed EEG monitors that generate numerical values for tracking anesthesia depth. However, in this study, anesthesia depth will be monitored using both the standard numerical BIS index and the Density Spectral Array (DSA) mode, an advanced feature of the BIS device. To date, no studies have simultaneously examined BIS and DSA modes in relation to cognitive function and the recovery process.

The use of advanced monitoring techniques may serve as a valuable resource for future research, particularly in optimizing anesthetic management for geriatric patients with reduced cognitive reserve. This study aims to evaluate the effects of different intraoperative anesthesia depth monitoring approaches, including hemodynamic monitoring, numerical BIS values, and DSA functions. The primary objective is to determine the optimal anesthesia monitoring strategy that minimizes intraoperative hypotension, burst suppression, and postoperative delirium.

Enrollment: 75 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 65 years and older
• Elective spinal surgeries
• ASA status I-III

Exclusion criteria

• Emergent surgeries
• ASA status IV-V
• Prediagnosed delirium and or dementia
• Inability to give consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

75 participants in 3 patient groups

Hemodynamic-Guided Group

Active Comparator group

Description:

Anesthesia depth monitoring will be managed according to hemodynamic parameters, primarily avoiding hypotension.

Treatment:

Other: Control Group: Standard Hemodynamic Monitoring

BIS-Guided Group

Active Comparator group

Description:

Anaesthesia depth monitoring according to numeric BIS index values

Treatment:

Device: Processed Electroencephalogram (BIS Index)

DSA-Guided Group

Active Comparator group

Description:

Anesthesia depth monitoring using the Density Spectral Array (DSA) function of the BIS monitor.

Treatment:

Device: Processed Electroencephalogram (DSA Mode)