Determination of Dose-response Curves Between Propofol Concentration and Intraoperative Electroencephalographic Patterns Until Burst Suppression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in the alpha power of EEG Spectrogram
研究概览
简要总结
In the world, 230 million surgeries are performed per year and a significant part is performed in patients over 65 years of age. These patients are more labile, especially from the neurocognitive point of view with a high risk to develop neurocognitive complications, such as postoperative delirium. Recent studies have linked this type of complication with an overdose of general anesthetics during surgery. For this reason, in recent years, the use of brain function monitors during the intraoperative period has been recommended to adapt the dosage of the drugs to each patient and thus to avoid overdosing of general anesthetics. However, to date, the available monitors that process the electroencephalographic signal are not able to adequately discriminate gradual changes in anesthetic depth. Also, no systematic studies have been performed that analyze changes that occur in the electroencephalogram (EEG) signal secondary to increases in complications from general anesthetics. Thus, the investigators design this study with the main aim to determine the changes in electroencephalographic patterns induced by a stepped increase of propofol until the burst suppression is reached.
详细描述
The investigators will carry out a prospective analytical observational clinical study at the Clinical Hospital of the University of Chile. In total 15 patients will be recruited, in who a frontal electroencephalographic signal will be recorded using a SedLine® monitor, and propofol concentration will be estimated using the Marsh model. First, the concentration of propofol at the loss of consciousness (LOS) will be recorded in the presence of remifentanil (7.5 ng/mL). Then, patients will be intubated and remifentanil will be decreased to 4 ng/mL. After that, the concentration of propofol that caused the LOS will be maintained for 20 minutes. Finally, propofol will be increased in steps of 0.3 mcg/mL for 7 min, until an episode of burst suppression will be observed. In the complete protocol, EEG activity will be acquired using a SedLine® monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) Physical Status 1 or 2
- •Low-risk surgery
排除标准
- •BMI > 35 kg/m2
- •Benzodiazepines use
- •Psychiatric disorder
- •Kidney disease
- •Liver disease
- •Brain damage
研究组 & 干预措施
Dose-response
-
- Concentration of propofol at the loss of consciousness (LOS) will be recorded in the presence of remifentanil (7.5 ng/mL) (LOS time).
-
- Patients will be intubated and remifentanil will be decreased to 4 ng/mL.
-
- Concentration of propofol that caused the LOS will be maintained for 20 minutes (Baseline time).
-
- Propofol will be increased in steps of 0.3 mcg/mL for 7 minutes until an episode of burst suppression will be observed (Burst suppression time).
EEG activity will be acquired using a SedLine® monitor during the complete protocol.
干预措施: Propofol (Drug)
Dose-response
-
- Concentration of propofol at the loss of consciousness (LOS) will be recorded in the presence of remifentanil (7.5 ng/mL) (LOS time).
-
- Patients will be intubated and remifentanil will be decreased to 4 ng/mL.
-
- Concentration of propofol that caused the LOS will be maintained for 20 minutes (Baseline time).
-
- Propofol will be increased in steps of 0.3 mcg/mL for 7 minutes until an episode of burst suppression will be observed (Burst suppression time).
EEG activity will be acquired using a SedLine® monitor during the complete protocol.
干预措施: Electroencephalogram recording (Device)
结局指标
主要结局
Change in the alpha power of EEG Spectrogram
时间窗: Change between baseline time (0 minutes) and burst suppression time (35 minutes)
% of change
次要结局
- Change in the coherence(Change between baseline time (0 minutes) and burst suppression time (35 minutes))
- Change in the delta power of EEG Spectrogram(Change between baseline time (0 minutes) and burst suppression time (35 minutes))
- Change in the propofol concentration(Change between baseline time (0 minutes) and burst suppression time (35 minutes))
研究者
Antonello Penna
Principal Investigator, Anesthesiologist, MD-PhD
University of Chile