Density Spectral Array Provides Intraoperative Precision Anesthesia and Analgesia Management; A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Total Amount of Propofol Consumption
研究概览
简要总结
The purpose of this study is to compare two different methods of monitoring brain activity (anesthesia depth) during gynecological surgeries.
When patients undergo surgery under general anesthesia, doctors use monitors to ensure they are at the right level of sleep and pain relief. Traditionally, a method called the Bispectral Index (BIS) is used, which provides a single number to represent brain activity. A newer method, called Density Spectral Array (DSA), provides a more detailed, color-coded map of brain waves in real-time.
Researchers want to see if using the more detailed DSA map helps anesthesiologists adjust medication more precisely. The study will compare the total amount of anesthetic and pain-relief drugs used in patients monitored with DSA versus those monitored with BIS. The goal is to determine if DSA leads to more personalized care, potentially reducing drug use and improving recovery after surgery
详细描述
This prospective observational study will include 45 patients undergoing elective gynecological oncology surgery under general anesthesia. Patients will be monitored using standard anesthesia monitoring (Pulse oximetry, non-invasive blood pressure, ECG, and ETCO2) along with brain activity monitoring.
The anesthesia management will follow a Total Intravenous Anesthesia (TIVA) protocol consisting of propofol, remifentanil, and lidocaine. Patients will be divided into two groups based on the anesthesiologist's preference for monitoring anesthesia depth: the Bispectral Index (BIS) group and the Density Spectral Array (DSA) group.
Hemodynamic parameters (heart rate, blood pressure), BIS values, and DSA images will be recorded at specific intervals: before induction, after induction, at the start of surgery, every 30 minutes during the procedure, at the end of surgery, and after extubation. The total amounts of propofol and remifentanil used during the operation will be documented for each patient.
In the postoperative period, patients will be monitored in the recovery unit at the 15th, 30th, and 60th minutes. Visual Analog Scale (VAS) scores for pain, additional analgesic requirements, and hemodynamic parameters will be recorded. Once orientation and cooperation are established, patients will also be evaluated for any signs of intraoperative awareness
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 65 years
- •ASA physical status I-III
- •Patients scheduled for elective gynecological oncology surgery
- •Body mass index (BMI) ≤ 35 kg/m²
- •Able to provide voluntary informed consent
- •Patients who do not require premedication
排除标准
- •Allergy or hypersensitivity to propofol, opioids, or lidocaine
- •Liver failure or kidney failure
- •Previous adjuvant chemotherapy
- •Emergency surgery
- •Operations lasting longer than 3 hours
- •Neurological diseases such as epilepsy, Alzheimer's disease, or dementia
- •Cerebrovascular disease or known brain lesions
- •Heart conduction disorders such as high-degree atrioventricular block
- •Patients requiring premedication
- •History of chronic pain
- •Chronic opioid use
- •Diabetes mellitus with neuropathy
- •Patients unable to establish cooperation
研究组 & 干预措施
DSA Group (Density Spectral Array)
Patients in this group will have their anesthesia depth monitored and managed using Density Spectral Array (DSA) in addition to standard monitoring. Anesthesia will be maintained using a Total Intravenous Anesthesia (TIVA) protocol with propofol, remifentanil, and lidocaine. The anesthesiologist will adjust the drug infusion rates based on real-time color-coded brain wave maps provided by the DSA to maintain an optimal level of anesthesia and analgesia.
干预措施: Density Spectral Array (DSA) Monitoring (Device)
BIS Group (Bispectral Index)
Patients in this group will have their anesthesia depth monitored and managed using the Bispectral Index (BIS) in addition to standard monitoring. Anesthesia will be maintained using a Total Intravenous Anesthesia (TIVA) protocol with propofol, remifentanil, and lidocaine. The anesthesiologist will adjust the drug infusion rates based on the numerical BIS values (target range 40-60) to maintain an optimal level of anesthesia and analgesia.
干预措施: Bispectral Index (BIS) Monitoring (Device)
结局指标
主要结局
Total Amount of Propofol Consumption
时间窗: From the start of anesthesia induction until the end of the surgical procedure (approximately 1 to 3 hours).
The total amount of propofol (in milligrams) administered to the patient during the entire surgical procedure to maintain the target anesthesia depth. The study compares whether monitoring with Density Spectral Array (DSA) leads to a significant reduction in total propofol consumption compared to Bispectral Index (BIS) monitoring.
次要结局
- Total Amount of Remifentanil Consumption(From the start of anesthesia induction until the end of the surgical procedure (approximately 1 to 3 hours).)
- Postoperative Pain Scores (Visual Analog Scale - VAS)(At the 15th, 30th, and 60th minutes in the post-anesthesia care unit (PACU).)
- Postoperative Rescue Analgesic Requirement(During the first 60 minutes in the post-anesthesia care unit (PACU).)
研究者
Muhammed Burak Çalışıcı
Doctor of Anesthesiology and Reanimation
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital