[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"consciousness-monitors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:consciousness-monitors":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100628344","eeg-signal-correlates-during-anesthesia-and-sedation-in-adults-and-children-100628344",false,"NCT07460414","EEG Signal Correlates During Anesthesia and Sedation in Adults and Children","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","SPECTRALADUPED","INCLUSION CRITERIA:\n\nFor adult patients:\n\n* Age ≥18 years (Cohort 2: \\>70 years; Cohort 3: ≥18 years)\n* Scheduled for general anesthesia (Cohort 2) or procedural sedation (Cohort 3)\n* Pre-anesthetic consultation completed\n* Informed of the study and non-opposition obtained\n\nFor pediatric patients (Cohort 1):\n\n* Age 1-17 years\n* Scheduled for general anesthesia for surgical procedure\n* For ASD subgroup: Confirmed DSM-5 diagnosis of autism spectrum disorder\n* Parental authority holder informed and non-opposition obtained\n* Child informed (if age-appropriate) and non-opposition obtained\n\nEXCLUSION CRITERIA:\n\nFor adult patients:\n\n* Documented cognitive impairment in medical record\n* Patient refusal to participate\n* Patient deprived of liberty or under legal protection\n* Pregnant or breastfeeding women\n\nFor pediatric patients:\n\n* Parental refusal of child's participation\n* Child refusal (if age-appropriate to understand)","ALL","1 Year",{"count":20,"type":21},330,"ESTIMATED","OBSERVATIONAL","This prospective, multicenter, non-interventional observational study investigates the correlates between electroencephalographic (EEG) signals and pharmacological\u002Fclinical 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):\n\n1. Pediatric cohort (n=110): Children aged 1-17 years undergoing general anesthesia, including 55 with autism spectrum disorder (ASD) and 55 without ASD.\n2. Elderly adult cohort (n=110): Patients over 70 years undergoing scheduled surgery under general anesthesia.\n3. Procedural sedation cohort (n=110): Adults ≥18 years undergoing procedural sedation for digestive endoscopy.\n\nEEG 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.\n\nSecondary 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.",[25,26,27],"Anesthesia","Sedation","Consciousness Monitors",[29],"general anesthesia","NOT_YET_RECRUITING","2026-03-04",{"date":33,"type":34},"2026-03-10","ACTUAL",{"date":36,"type":21},"2026-03-15",{"date":38,"type":21},"2027-05-15",{"name":40,"class":41},"Assistance Publique - Hôpitaux de Paris","OTHER",2]