Geriatrik Hasta Grubunda Anestezi Derinliği Monitörizasyonlarının Postoperatif Derlenme Ve Bilişsel Fonksiyonlara Etkileri
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Ratio of Burst Suppression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years and older
- •Elective spinal surgeries
- •ASA status I-III
排除标准
- •Emergent surgeries
- •ASA status IV-V
- •Prediagnosed delirium and or dementia
- •Inability to give consent
研究组 & 干预措施
Hemodynamic-Guided Group
Anesthesia depth monitoring will be managed according to hemodynamic parameters, primarily avoiding hypotension.
干预措施: Control Group: Standard Hemodynamic Monitoring (Other)
BIS-Guided Group
Anaesthesia depth monitoring according to numeric BIS index values
干预措施: Processed Electroencephalogram (BIS Index) (Device)
DSA-Guided Group
Anesthesia depth monitoring using the Density Spectral Array (DSA) function of the BIS monitor.
干预措施: Processed Electroencephalogram (DSA Mode) (Device)
结局指标
主要结局
Ratio of Burst Suppression
时间窗: Intraoperative (continuously recorded from anesthesia induction to emergence)
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 of Burst Suppression
时间窗: Intraoperative (continuously recorded from anesthesia induction to emergence)
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 Hypotension Incidence
时间窗: Intraoperative (assessed continuously throughout surgery)
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.
Alpha Band Preservation or Loss
时间窗: Intraoperative (measured continuously from anesthesia induction to emergence)
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.
次要结局
- 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)
研究者
Aslıhan Güleç
MD, Specialist in Anesthesiology and Reanimation
Gazi University