About this trial
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 criteria
Qualifiers
Age ≥18 years (Cohort 2: >70 years; Cohort 3: ≥18 years)
Scheduled for general anesthesia (Cohort 2) or procedural sedation (Cohort 3)
Pre-anesthetic consultation completed
Informed of the study and non-opposition obtained
Disqualifiers
Documented cognitive impairment in medical record
Patient refusal to participate
Patient deprived of liberty or under legal protection
Pregnant or breastfeeding women
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Ecole Normale Supérieure de Paris
Collaborator
Bichat Hospital
Collaborator
Hôpital Louis Mourier
Collaborator