Propofol versus sevoflurane effects on frontal EEG alpha power during anesthesia
Comparison of EEG Power Spectrum During Maintenance of Anesthesia With Propofol Versus Sevoflurane
This trial will test whether propofol or sevoflurane produces different frontal EEG alpha power in adults having elective electrophysiology procedures under general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT07561970 on ClinicalTrials.gov |
What this trial studies
Adult patients undergoing elective electrophysiological procedures under general anesthesia will receive maintenance anesthesia with either intravenous propofol or inhaled sevoflurane while frontal EEG is recorded using the NeuroSense® depth-of-anesthesia monitor. The primary outcome is frontal EEG alpha power (dB) during maintenance, and secondary outcomes include comparisons of other EEG frequency bands. Spectral data from the two maintenance groups will be analyzed to detect differences and to explore cut-off values that might predict higher risk of postoperative delirium. The protocol excludes patients with certain cardiac conditions, preoperative cognitive impairment, benzodiazepine or antiepileptic use, morbid obesity, and other factors that could confound EEG signals.
Who should consider this trial
Good fit: Adults scheduled for elective electrophysiology interventions (for example atrial fibrillation ablation) at the participating center who can give informed consent, speak French, and meet the cardiac, cognitive, and medication eligibility criteria are ideal candidates.
Not a fit: Emergency patients, those with preoperative cognitive impairment, patients taking benzodiazepines or antiepileptic drugs, people with significant cardiac dysfunction, morbid obesity, or severe nausea/vomiting history are unlikely to benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, the findings could help identify patients at higher risk of postoperative delirium and guide anesthetic choice or monitoring to reduce that risk.
How similar studies have performed: Prior observational work, including a 220-patient cohort under sevoflurane, linked lower intraoperative frontal alpha power to higher postoperative delirium risk, but a direct head-to-head comparison of propofol versus sevoflurane for EEG spectral differences is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brussels
- Cliniques universitaires Saint-Luc — Brussels, Belgium (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.