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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Correlation of EEG features with pharmacological and clinical parameters during anesthesia
研究概览
简要总结
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):
- Pediatric cohort (n=110): Children aged 1-17 years undergoing general anesthesia, including 55 with autism spectrum disorder (ASD) and 55 without ASD.
- Elderly adult cohort (n=110): Patients over 70 years undergoing scheduled surgery under general anesthesia.
- 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.
详细描述
BACKGROUND AND RATIONALE:
Monitoring depth of anesthesia using electroencephalography (EEG) has become standard clinical practice, particularly through processed indices like the Bispectral Index (BIS). However, the underlying neurophysiological mechanisms and relationships between raw EEG signals and clinical/pharmacological parameters remain incompletely understood. Current monitoring systems provide processed indices but limited insight into raw multi-channel EEG signal characteristics. Systematic analysis of EEG data across different patient populations, age groups, and anesthetic contexts is needed to advance our understanding of brain responses to anesthesia and improve monitoring strategies.
STUDY DESIGN:
This is a prospective, multicenter, non-interventional, observational cohort study conducted at two sites of the Assistance Publique - Hôpitaux de Paris (AP-HP): Bichat-Claude Bernard Hospital and Louis Mourier Hospital. The study involves no modifications to routine anesthetic care - only collection and analysis of EEG data during standard clinical practice.
STUDY POPULATIONS:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
COHORT 3 - Procedural Sedation (n=110)
Adults ≥18 years undergoing procedural sedation for digestive endoscopy at Louis Mourier Hospital.
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.
结局指标
主要结局
Correlation of EEG features with pharmacological and clinical parameters during anesthesia
时间窗: During anesthesia/sedation procedure (typically 1-6 hours per participant)
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.
Development of mathematical tools for EEG analysis during maintenance phase
时间窗: During anesthesia maintenance phase (varies per participant, typically 1-5 hours)
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).
次要结局
- EEG profile analysis in children with autism spectrum disorder during anesthesia(Throughout entire anesthesia procedure (typically 1-6 hours per participant))
- 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))
- Consistency of individual anesthetic sensitivity across emergence(Throughout entire anesthesia procedure (induction through emergence, typically 1-6 hours))
- EEG correlates predicting complication-free tracheal extubation in children(During emergence phase preceding tracheal extubation (typically 10-30 minutes))