COmparison of Maintenance of Propofol And Sevoflurane Spectral Study (COMPASS)
Comparison of EEG Power Spectrum During Maintenance of Anesthesia With Propofol Versus Sevoflurane
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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Brussels、ベルギー、1200
- 募集
- Cliniques universitaires Saint-Luc
-
コンタクト：
- Céline Khalifa, MD PhD
- 電話番号：+3227641821
- メール：celine.khalifa@saintluc.uclouvain.be
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コンタクト：
- Laetitia Miltoni, MD
- 電話番号：+3227641821
-
副調査官：
- Christine Watremez, MD PhD
-
副調査官：
- Mona Momeni, MD PhD
-
副調査官：
- David Kahn, MD
-
主任研究者：
- Céline Khalifa, MD PhD
-
副調査官：
- Robert Tircoveanu, MD
-
副調査官：
- Aurélie Jacobs Sariyar, MD
-
副調査官：
- Maximilien Cappe, MD
-
副調査官：
- Lina Puodzukaite, MD
-
副調査官：
- Guillaume Lemaire, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria: Adult patients undergoing elective electrophysiological interventions, such as atrial fibrillation ablation procedures, under general anesthesia
- Capable to give informed consent
- French-speaking patients
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Propofol maintenance
|
Maintenance of general anesthesia for simple electrophysiological procedures
|
|
実験的：Sevoflurane maintenance
|
Maintenance of general anesthesia for simple electrophysiological procedures
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Alpha-band power
時間枠：Intra-operative
|
Power in decibels from the NeuroWave monitor under general anesthesia
|
Intra-operative
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Delta-band power
時間枠：Intra-operative
|
Power in decibels from the NeuroWave monitor
|
Intra-operative
|
|
Thêta-band power
時間枠：Intra-operative
|
Power in decibel from the NeuroWave monitor
|
Intra-operative
|
|
Bêta-band power
時間枠：Intra-operative
|
Power in decibel from the NeuroWave monitor
|
Intra-operative
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2025/15JUL/299
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