The Effects of Anesthesia Depth Monitoring on Postoperative Recovery and Cognitive Functions in the Geriatric Patient Population
NCT ID: NCT06844279
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
75 participants
INTERVENTIONAL
2025-01-10
2025-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Hemodynamic-Guided Group
Anesthesia depth monitoring will be managed according to hemodynamic parameters, primarily avoiding hypotension.
Control Group: Standard Hemodynamic Monitoring
Anesthesia depth monitoring based on hemodynamic values without additional processed EEG guidance.
BIS-Guided Group
Anaesthesia depth monitoring according to numeric BIS index values
Processed Electroencephalogram (BIS Index)
Anaesthesia depth monitoring according to numeric BIS index values.
DSA-Guided Group
Anesthesia depth monitoring using the Density Spectral Array (DSA) function of the BIS monitor.
Processed Electroencephalogram (DSA Mode)
Anaesthesia depth monitoring according to density spectral array functions
Interventions
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Control Group: Standard Hemodynamic Monitoring
Anesthesia depth monitoring based on hemodynamic values without additional processed EEG guidance.
Processed Electroencephalogram (BIS Index)
Anaesthesia depth monitoring according to numeric BIS index values.
Processed Electroencephalogram (DSA Mode)
Anaesthesia depth monitoring according to density spectral array functions
Eligibility Criteria
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Inclusion Criteria
* Elective spinal surgeries
* ASA status I-III
Exclusion Criteria
* ASA status IV-V
* Prediagnosed delirium and or dementia
* Inability to give consent
65 Years
ALL
No
Sponsors
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Aslıhan Güleç
OTHER
Responsible Party
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Aslıhan Güleç
MD, Specialist in Anesthesiology and Reanimation
Principal Investigators
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Zerrin Ozkose Satirlar, Professor
Role: STUDY_DIRECTOR
Gazi University
Locations
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Gazi University School of Medicine
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Gazi-2024 -1816
Identifier Type: -
Identifier Source: org_study_id
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