EEG Signal Correlates During Anesthesia and Sedation in Adults and Children

Condition(s) studied

Study summary

This prospective, multicenter, non-interventional observational study investigates the correlates between electroencephalographic (EEG) signals and pharmacological/clinical parameters during general anesthesia and procedural sedation. The study will enroll 330 participants across three distinct populations at two AP-HP sites (Bichat-Claude Bernard Hospital and Louis Mourier Hospital):

1. Pediatric cohort (n=110): Children aged 1-17 years undergoing general anesthesia, including 55 with autism spectrum disorder (ASD) and 55 without ASD.
2. Elderly adult cohort (n=110): Patients over 70 years undergoing scheduled surgery under general anesthesia.
3. Procedural sedation cohort (n=110): Adults ≥18 years undergoing procedural sedation for digestive endoscopy.

EEG data will be collected using BIS and SedLine monitors during routine anesthetic care with no modifications to standard practice. The primary objective is to identify EEG signal features correlating with clinical and pharmacological parameters during induction, maintenance, and emergence phases.

Secondary objectives include developing predictive models for anesthetic depth, analyzing age-related differences, comparing effects of different anesthetic agents, and investigating specific EEG patterns in children with ASD. This study will enhance understanding of brain responses to anesthesia across different age groups and clinical contexts, potentially improving anesthetic monitoring algorithms and management strategies.

Eligibility

Primary outcome measure(s)

• Correlation of EEG features with pharmacological and clinical parameters during anesthesia — During anesthesia/sedation procedure (typically 1-6 hours per participant)
  Identification of electroencephalographic (EEG) signal features (spectral power in delta, theta, alpha, beta, gamma bands; coherence; entropy measures; burst suppression patterns) that demonstrate statistically significant correlation with: 1. Pharmacological parameters including anesthetic drug type, estimated effect-site concentration, drug combinations, and pharmacokinetic/pharmacodynamic properties 2. Clinical parameters including patient age, comorbidities, surgical stimulation intensity, hemodynamic changes, and clinical signs of consciousness level Correlations will be quantified using Pearson or Spearman correlation coefficients (as appropriate) and analyzed separately for induction, maintenance, and emergence phases. Features will be extracted from multi-channel EEG recordings using advanced signal processing and machine learning techniques.
• Development of mathematical tools for EEG analysis during maintenance phase — During anesthesia maintenance phase (varies per participant, typically 1-5 hours)
  Development of new mathematical descriptors to quantify spectral density matrix (SDM) EEG profiles during anesthesia maintenance in adults and children, distinguishing stationary phases from transitions between states. Collaboration with mathematical team at ENS (Prof. David Holcman). Measured variables: Novel mathematical descriptors quantifying SDM EEG profiles during anesthetic maintenance. Outcome: Linearity of relationship between quantitative descriptors and clinical anesthesia phase, measured by R² correlation coefficient between new descriptors and clinical classification (awake, induction, light/medium/deep maintenance, emergence).

Trial sites (2)

More Assistance Publique - Hôpitaux de Paris trials in France

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