NCT07460414

Brief 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. 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. 2.Elderly adult cohort (n=110): Patients over 70 years undergoing scheduled surgery under general anesthesia.
  3. 3.Procedural sedation cohort (n=110): Adults ≥18 years undergoing procedural sedation for digestive endoscopy.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Mar 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Mar 2026May 2027

First Submitted

Initial submission to the registry

March 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2027

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

March 4, 2026

Last Update Submit

March 4, 2026

Conditions

AnesthesiaSedationConsciousness Monitors

Keywords

general anesthesia

Outcome Measures

Primary Outcomes (2)

  • Correlation of EEG features with pharmacological and clinical parameters during anesthesia

    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.

    During anesthesia/sedation procedure (typically 1-6 hours per participant)

  • Development of mathematical tools for EEG analysis during maintenance phase

    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).

    During anesthesia maintenance phase (varies per participant, typically 1-5 hours)

Secondary Outcomes (8)

  • Development of mathematical tools for induction phases

    During induction (typically 2-5 minutes) and emergence (typically 5-20 minutes)

  • Development of mathematical tools for emergence phases

    During induction (typically 2-5 minutes) and emergence (typically 5-20 minutes)

  • Analysis of individual sensitivity to anesthetic drugs during induction

    During induction phase (first 2-5 minutes of anesthetic exposure)

  • Consistency of individual anesthetic sensitivity across induction

    Throughout entire anesthesia procedure (induction through emergence, typically 1-6 hours)

  • Consistency of individual anesthetic sensitivity across maintenance

    Throughout entire anesthesia procedure (induction through emergence, typically 1-6 hours)

  • +3 more secondary outcomes

Study Arms (3)

COHORT 1 - Pediatric (n=110)

Children aged 1-17 years undergoing general anesthesia, including 55 with ASD and 55 without ASD.

COHORT 2 - Elderly Adults (n=110)

Patients over 70 years undergoing scheduled surgery under general anesthesia at Bichat-Claude Bernard Hospital.

COHORT 3 - Procedural Sedation (n=110)

Adults ≥18 years undergoing procedural sedation for digestive endoscopy at Louis Mourier Hospital.

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

For adults: Patients over 70 years of age who need to benefit from general anesthesia for surgery (Bichat-Claude Bernard or Louis Mourier). Adult patients (\> 18 years old) who should benefit from procedural sedation for digestive endoscopies (Louis Mourier). For children: Children over 1 year of age (and weighing \> 10 kg) who need to benefit from general anesthesia for dental or ENT surgery at the Louis Mourier Hospital (including children with autism spectrum disorder)

You may qualify if:

  • For adult patients:
  • 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
  • For pediatric patients (Cohort 1):
  • Age 1-17 years
  • Scheduled for general anesthesia for surgical procedure
  • For ASD subgroup: Confirmed DSM-5 diagnosis of autism spectrum disorder
  • Parental authority holder informed and non-opposition obtained
  • Child informed (if age-appropriate) and non-opposition obtained

You may not qualify if:

  • For adult patients:
  • Documented cognitive impairment in medical record
  • Patient refusal to participate
  • Patient deprived of liberty or under legal protection
  • Pregnant or breastfeeding women
  • For pediatric patients:
  • Parental refusal of child's participation
  • Child refusal (if age-appropriate to understand)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Bichat-Claude Bernard

Paris, Ap-hp DRCI, 75010, France

Location

Hôpital Louis Mourier

Colombes, 92700, France

Location

Study Officials

  • Dan Longrois, MD, PHD

    Assistance Publique Hopitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Longrois, MD, PHD

CONTACT

01 47 60 61 35dan.longrois@aphp.fr

David Holcman, MD, PHD

CONTACT

01 44 32 36 61holcman.david@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 10, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

May 15, 2027

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)