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EEG Signal Correlates During Anesthesia and Sedation in Adults and Children

NCT07460414 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2026-03-10

No results posted yet for this 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.

Conditions

  • Anesthesia
  • Sedation
  • Consciousness Monitors

Sponsors & Collaborators

  • Ecole Normale Supérieure de Paris

    collaborator UNKNOWN

  • Bichat Hospital

    collaborator OTHER

  • Hôpital Louis Mourier

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Dan Longrois, MD, PHD · Assistance Publique Hopitaux de Paris

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2027-04-15
Completion
2027-05-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07460414 on ClinicalTrials.gov