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

NCT06844279 | Recruiting FDA Device

• 1 other identifier: Gazi-2024 -1816
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

anaesthesia depth monitoring; geriatric; density spectral array; bispectral index; burst supression; postoperative delirium

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Intraoperative (measured continuously from anesthesia induction to emergence)

Secondary Outcomes (5)

• Incidence of Postoperative Delirium Assessed via CAM Scale

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

• Total Intraoperative Propofol Consumption

  Intraoperative

• Total Intraoperative Sevoflurane Consumption

  Intraoperative

• Total Intraoperative Remifentanil Consumption

  Intraoperative

• Total Intraoperative Vasopressor Consumption

  Intraoperative

Other Outcomes (1)

• Frailty Score Assessed via Clinical Frailty Scale (CFS)

  Preoperative (assessed on the day of surgery)

Study Arms (3)

Hemodynamic-Guided Group

ACTIVE COMPARATOR

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

Other: Control Group: Standard Hemodynamic Monitoring

BIS-Guided Group

ACTIVE COMPARATOR

Anaesthesia depth monitoring according to numeric BIS index values

Device: Processed Electroencephalogram (BIS Index)

DSA-Guided Group

ACTIVE COMPARATOR

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

Device: Processed Electroencephalogram (DSA Mode)

Interventions

Control Group: Standard Hemodynamic Monitoring OTHER

Anesthesia depth monitoring based on hemodynamic values without additional processed EEG guidance.

Hemodynamic-Guided Group

Processed Electroencephalogram (BIS Index) DEVICE

Anaesthesia depth monitoring according to numeric BIS index values.

BIS-Guided Group

Processed Electroencephalogram (DSA Mode) DEVICE

Anaesthesia depth monitoring according to density spectral array functions

DSA-Guided Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aslıhan Güleç: lead

Study Sites (1)

Gazi University School of Medicine

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.

  PMID: 26275092 BACKGROUND

• Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594.

  PMID: 28187050 BACKGROUND

• Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005.

  PMID: 30721296 BACKGROUND

• Chen YC, Hung IY, Hung KC, Chang YJ, Chu CC, Chen JY, Ho CH, Yu CH. Incidence change of postoperative delirium after implementation of processed electroencephalography monitoring during surgery: a retrospective evaluation study. BMC Anesthesiol. 2023 Oct 4;23(1):330. doi: 10.1186/s12871-023-02293-9.

  PMID: 37794315 BACKGROUND

• Shao YR, Kahali P, Houle TT, Deng H, Colvin C, Dickerson BC, Brown EN, Purdon PL. Low Frontal Alpha Power Is Associated With the Propensity for Burst Suppression: An Electroencephalogram Phenotype for a "Vulnerable Brain". Anesth Analg. 2020 Nov;131(5):1529-1539. doi: 10.1213/ANE.0000000000004781.

  PMID: 33079876 BACKGROUND

• Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.

  PMID: 26418126 BACKGROUND

• Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.

  PMID: 18156878 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

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

Study Officials

• Zerrin Ozkose Satirlar, Professor

  Gazi University

  STUDY DIRECTOR

Central Study Contacts

Aslihan Gulec Kilic, MD

CONTACT

+905072709000; aslihangulec@gazi.edu.tr

Gozde Inan, Associate Professor

CONTACT

+905358105620; inangozde@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Specialist in Anesthesiology and Reanimation

Model Details: Group 1: Anaesthesia depth monitoring according to hemodynamic values Group 2: Anaesthesia depth monitoring according to numeric BIS values (numbers between 40 to 60 is aimed) Group 3: Anaesthesia depth monitoring according to DSA function (avoiding obvious burst supression and keeping alpha band in high frequency)

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 25, 2025
• Study Start: January 10, 2025
• Primary Completion: March 15, 2025
• Study Completion: April 1, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending one year after the publication
• Access Criteria: Access to study protocol upon request, contact with one of the sub-investigators.

Locations

TU (1)