Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07460414

EEG Signal Correlates During Anesthesia and Sedation in Adults and Children

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: Study of Pharmacological and Clinical Correlates of the Electroencephalographic Signal During Induction, Maintenance and Emergence Phases of General Anesthesia or Procedural Sedation in Adults and General Anesthesia in Children

Key Details

Gender

All

Age Range

1 Year - Any

Study Type

OBSERVATIONAL

Enrollment

330

Start Date

2026-03-15

Completion Date

2027-05-15

Last Updated

2026-03-10

Healthy Volunteers

No

Locations (2)

Hôpital Bichat-Claude Bernard

Paris, Ap-hp DRCI, France

Hôpital Louis Mourier

Colombes, France