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
This trial does not accept healthy volunteersQualifiers
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 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)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
330 Participants
are grouped into 3 trial groupsGroup A: COHORT 1 - Pediatric (n=110)
Group B: COHORT 2 - Elderly Adults (n=110)
Group C: COHORT 3 - Procedural Sedation (n=110)
Trial outcomes
Primary outcomes
1
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.
Time frame
During anesthesia/sedation procedure (typically 1-6 hours per participant)2
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).
Time frame
During anesthesia maintenance phase (varies per participant, typically 1-5 hours)Secondary outcomes
1
Development of mathematical tools for induction phases
Development of mathematical analysis tools specific to induction and emergence phases (adults and children). These phases involve much more rapid changes (seconds for induction, tens of seconds for emergence) compared to maintenance (minutes to hours) in both drug doses/concentrations and EEG profiles. Measured variables: New mathematical descriptors specific to induction and emergence phases. Outcome: Linearity of relationship between new descriptors and hypnotic drug doses/concentrations, measured by R² correlation coefficient and slope of dose-descriptor relationship during transition phases.
Time frame
During induction (typically 2-5 minutes) and emergence (typically 5-20 minutes)2
Development of mathematical tools for emergence phases
Development of mathematical analysis tools specific to induction and emergence phases (adults and children). These phases involve much more rapid changes (seconds for induction, tens of seconds for emergence) compared to maintenance (minutes to hours) in both drug doses/concentrations and EEG profiles. Measured variables: New mathematical descriptors specific to induction and emergence phases. Outcome: Linearity of relationship between new descriptors and hypnotic drug doses/concentrations, measured by R² correlation coefficient and slope of dose-descriptor relationship during transition phases.
Time frame
During induction (typically 2-5 minutes) and emergence (typically 5-20 minutes)3
Analysis of individual sensitivity to anesthetic drugs during induction
Test the hypothesis that individual sensitivity to anesthetic drugs can be analyzed in the first minutes of anesthetic induction. Outcome measure: Slope of the linear relationship (established in SO2) between hypnotic dose/concentration and numerical descriptor obtained in SO2. A slope closer to 1 indicates increased sensitivity. Applies to induction protocols used in adults (intravenous propofol injection) and children (sevoflurane inhalation).
Time frame
During induction phase (first 2-5 minutes of anesthetic exposure)4
Consistency of individual anesthetic sensitivity across induction
Test the hypothesis that individual sensitivity to anesthetic drugs identified during induction (SO3) remains constant during maintenance and emergence phases. Outcome: Correlations between slopes of dose/concentration-descriptor relationships (obtained in SO1 and SO2) across the three phases (induction, maintenance, emergence). Assessment of repeatability over time of dose-response relationship, measured by geometric mean error of predicted versus observed transition duration, adjusted for relevant covariates (dose changes, etc.).
Time frame
Throughout entire anesthesia procedure (induction through emergence, typically 1-6 hours)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Ecole Normale Supérieure de Paris
Collaborator
Bichat Hospital
Collaborator
Hôpital Louis Mourier
Collaborator
Source ClinicalTrials.gov
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