跳至主要内容
临床试验/NCT07561970
NCT07561970招募中不适用

Comparison of EEG Power Spectrum During Maintenance of Anesthesia With Propofol Versus Sevoflurane

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2026年4月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
280
试验地点
1
主要终点
Alpha-band power

研究概览

简要总结

Lower EEG alpha band power is currently extensively studied as a potential biomarker of brain vulnerability. No previous study has evaluated whether there was a difference in EEG power spectrum ranges between propofol and sevoflurane, the two main anesthetic agents for maintenance of general anesthesia, in order to define a cut-off value for the prediction of a higher risk of postoperative delirium.

  • Primary objective: comparison of EEG alpha power (dB) during maintenance of anesthesia with propofol and sevoflurane using data available in the NeuroSense® depth-of-anesthesia monitoring
  • Secondary objectives: comparison of other EEG frequency bands during maintenance of anesthesia with propofol and sevoflurane using data from the NeuroSense® depth-of-anesthesia monitoring

详细描述

Since the development and commercialization of quantitative EEG monitors, which compute an index to assess the depth of sedation, the interest of anesthesiologists for neurophysiology has increased considerably. Indeed, frontal EEG represents an accessible, non-invasive technique to monitor the brain, the target-organ of our hypnotic drugs.

Anesthesia interferes with the physiological oscillations generated by the brain, and these disturbances impact the EEG. For instance, common hypnotic agents used for the maintenance of general anesthesia, intravenous propofol or inhaled sevoflurane, provide a typical pattern on the raw EEG related to their main mechanism of action: predominant simultaneous frontal slow/delta (0.1-4 Hz) and alpha (8-12 Hz) oscillations.

Intraoperative alpha oscillations are currently being extensively studied, as they might be a potential biomarker of brain vulnerability, which could help in predicting postoperative delirium, one of the most prevalent neurological complication after surgery. Recently, in a prospective observational cohort study including 220 patients, we showed that adult patients undergoing elective cardiac surgery under sevoflurane anesthesia who had lower intraoperative frontal EEG alpha band power were at higher risk of postoperative delirium. Lower intraoperative frontal EEG alpha band power was also correlated with poorer preoperative cognitive scores in our clinical series, which confirms previously published observations.

However, some practical questions still need to be addressed before this electroencephalographical marker can be integrated into a risk-prediction model for postoperative delirium. More specifically, we are not currently able to suggest a "universal" cut-off value for intraoperative frontal alpha-band power under general anesthesia that could be useful for a daily clinical practice. For example, an important issue is that the definition of the cut-off value will highly depend on the choice of anesthetic drugs. Although propofol and volatile anesthetics, such as sevoflurane, share similar neurophysiological characteristics, their respective EEG patterns and spectrograms are not identical (increased power in the thêta-band with volatile anesthetics). Otherwise, both propofol and sevoflurane EEG patters become completely different when they are used in combination with other anesthetic agents, such as benzodiazepines, ketamine or dexmedetomodine. These combinations are frequently used in multimodal anesthesia practice, and can deeply impact EEG frequency band power values. Consequently, at the moment, "low" alpha band power remains rather an observation on our patients' EEG spectrogram throughout surgery than a quantifiable value.

The main objective of this study is a first step towards to definition of a cut-off value for EEG frontal alpha band power to predict postoperative delirium. We aim to determine whether there is a significant difference in EEG power spectrum ranges between propofol and sevoflurane, the two main anesthetic maintenance agents. More precisely, it would require "simple", non-balanced, maintenance of general anesthesia using either propofol or sevoflurane, with the avoidance of any other hypnotic drugs. This type of maintenance is frequently used for minor interventions requiring general anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients undergoing elective electrophysiological interventions, such as atrial fibrillation ablation procedures, under general anesthesia
  • Capable to give informed consent
  • French-speaking patients

排除标准

  • Need for a premedication with benzodiazepine before anesthesia
  • Reduced left ventricular ejection fraction (< 50%) or underlying cardiac pathology requiring a more balanced anesthesia (administration of benzodiazepine and/or ketamine during anesthesia)
  • Preoperative MoCA score < 26/30 (for patients > ou = 55 years old)
  • Patients treated with anti-epileptic drugs
  • Patients treated with benzodiazepines (ex: for anxiolysis or sleep disorders)
  • Emergencies
  • Morbid obesity (BMI > 40kg/m2)
  • Background of severe postoperative nausea/vomit

研究组 & 干预措施

Propofol maintenance

Active Comparator

干预措施: Maintenance of general anesthesia by Propofol (Other)

Sevoflurane maintenance

Experimental

干预措施: Maintenance of general anesthesia by Sevoflurane (Other)

结局指标

主要结局

Alpha-band power

时间窗: Intra-operative

Power in decibels from the NeuroWave monitor under general anesthesia

次要结局

  • Delta-band power(Intra-operative)
  • Thêta-band power(Intra-operative)
  • Bêta-band power(Intra-operative)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (1)

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