EEG Signal Correlates During Anesthesia and Sedation in Adults and Children

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorAssistance Publique - Hôpitaux de Paris

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

330 Participants
are grouped into 3 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