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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Brussels, 벨기에, 1200
- 모병
- Cliniques universitaires Saint-Luc
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연락하다:
- Céline Khalifa, MD PhD
- 전화번호: +3227641821
- 이메일: celine.khalifa@saintluc.uclouvain.be
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연락하다:
- Laetitia Miltoni, MD
- 전화번호: +3227641821
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부수사관:
- Christine Watremez, MD PhD
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부수사관:
- Mona Momeni, MD PhD
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부수사관:
- David Kahn, MD
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수석 연구원:
- Céline Khalifa, MD PhD
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부수사관:
- Robert Tircoveanu, MD
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부수사관:
- Aurélie Jacobs Sariyar, MD
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부수사관:
- Maximilien Cappe, MD
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부수사관:
- Lina Puodzukaite, MD
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부수사관:
- Guillaume Lemaire, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Propofol maintenance
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Maintenance of general anesthesia for simple electrophysiological procedures
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실험적: Sevoflurane maintenance
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Maintenance of general anesthesia for simple electrophysiological procedures
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Alpha-band power
기간: Intra-operative
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Power in decibels from the NeuroWave monitor under general anesthesia
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Intra-operative
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Delta-band power
기간: Intra-operative
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Power in decibels from the NeuroWave monitor
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Intra-operative
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Thêta-band power
기간: Intra-operative
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Power in decibel from the NeuroWave monitor
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Intra-operative
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Bêta-band power
기간: Intra-operative
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Power in decibel from the NeuroWave monitor
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Intra-operative
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2025/15JUL/299
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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