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

Официальное название

Geriatrik Hasta Grubunda Anestezi Derinliği Monitörizasyonlarının Postoperatif Derlenme ve Bilişsel Fonksiyonlara Etkileri

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Ratio of Burst Suppression [Срок оценки: Intraoperative (continuously recorded from anesthesia induction to emergence)]
• Time of Burst Suppression [Срок оценки: Intraoperative (continuously recorded from anesthesia induction to emergence)]
• Intraoperative Hypotension Incidence [Срок оценки: Intraoperative (assessed continuously throughout surgery)]
• Alpha Band Preservation or Loss [Срок оценки: Intraoperative (measured continuously from anesthesia induction to emergence)]

Вторичные конечные точки (5)

• Incidence of Postoperative Delirium Assessed via CAM Scale [Срок оценки: Postoperative (assessed at 6, 24, and 48 hours after surgery)]
• Total Intraoperative Propofol Consumption [Срок оценки: Intraoperative]
• Total Intraoperative Sevoflurane Consumption [Срок оценки: Intraoperative]
• Total Intraoperative Remifentanil Consumption [Срок оценки: Intraoperative]
• Total Intraoperative Vasopressor Consumption [Срок оценки: Intraoperative]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Gazi University School of Medicine — Ankara

Публикации

• 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
• 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
• 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 Adu PMID 30721296
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06844279 · Gazi-2024 -1816

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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