An observational study in Electroencephalography, Sevoflurane and Child Neglect, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Recruiting at 1 site in China. Open to participants aged 1 Day to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Observational
Sevoflurane is one of the most commonly used volatile anesthetics in children because of its rapid induction, recovery and recovery properties. Clinical studies using noninvasive brain monitoring have shown that general anesthetics and hypnotics generate electroencephalogram (EEG) oscillations in specific spatial tissues that are fundamentally related to the structure and function of neural circuits. Slow-wave-delta (0.1-4 Hz) oscillations were present in children of all ages, and the advantage of frontal α-wave oscillations appeared at approximately 6 months, began to be consistent at 10 months, and persisted at older ages. Another study, which analyzed EEG under sevoflurane general anesthesia in children aged 0-6 months, found that Theta and alpha wave power decreased with a decrease in sevoflurane concentrations in infants between 4 and 6 months of recovery. However, these studies lack detailed characterization of the neural circuit activity associated with anesthesia, especially at specific developmental ages that are highly correlated with brain plasticity. The aim of this study was to explore electroencephalogram (EEG) of children of different ages under sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery) . By analyzing these EEG data in detail, we hope to be able to better understand the EEG characteristics of children of different ages under sevoflurane anesthesia, and thus develop a neurophysiology pediatric anesthesia status monitoring strategy.
This study is prospective and observational. Children under sevoflurane general anesthesia were divided into 14 groups (0-3 months old, 3-6 months old, 6-9 months old, 9-12 months old, 1-1.5 years old, 1.5-2 years old, 2-2.5 years old, 2.5-3 years old, 3-3.5 years old, 3.5-4 years old, 4-4.5 years old, 4.5.5 years old, 5.5.5 years old, 5.5-6 years old) , there were 20 cases in each group. Inform the family about the research plan and obtain informed consent. To observe the time-frequency characteristics of prefrontal electroencephalogram (EEG) in children of different ages under general anesthesia with sevoflurane.
Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 133 studies on the registry; 44 are open to participants now.
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The study population met the above inclusion criteria.
Exclusion Criteria:
EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
Time-frequency characteristics of electroencephalogram (EEG)
Time-frequency characteristics of electroencephalogram (EEG) in children of different ages during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery) .
Time frame: during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)
Modified observer's assessment of alertness#sedation#MOAA/S#scale
5#Subject responds readily to name spoken in a normal tone; 4 #Lethargic response of a subject to a name spoken in a normal tone; 3 #The subject responds only after a name is called loudly and repeatedly; 2 #The subject responds only after mild prodding or shaking; 1 #The subject responds only after a painful trapezius squeeze; 0 #The subject does not respond to painful trapezius squeeze. MOAA/S score ≤ 2 points represent successful sedation
Time frame: during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)
Recovery time
From the time sevoflurane was stopped until the child opened his eyes for the first time and reached an Aldrete score of ≥9
Time frame: Within up to 30 minutes after operation
Pediatric anesthesia emergence delirium
The pediatric anesthesia emergence delirium scale consists of four items. Each item is scored 0-4 yielding a total between 0 and 20.
Time frame: Within up to 30 minutes after operation
The Face, Legs, Activity, Cry, Consolability Scale (FLACC)
The FLACC scale consists of five items. Each item is scored 0-2 yielding a total between 0 and 10.
Time frame: Within up to 30 minutes after operation
PHBQ-AS
Post-Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) is a parental report measure used to assess negative behavior change after hospitalization, consisting of 11 items on 1-5 score. The PHBQ-AS score will be calculated for each respondent as the mean score of all individual items answered on the questionnaire. A score above 3 will indicate the presence of negative behavioral change, a score equal to 3 will indicate no behavioral change, and a score below 3 will indicate an improvement in behavior.
Time frame: 3 days after operation
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Second Affiliated Hospital of Wenzhou Medical University