The EEG Study Under Sevoflurane Anesthesia in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Electroencephalography, Sevoflurane, Child Neglect. Basic parameters: 1 Day — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Electroencephalogram Study in Children Under Sevoflurane Anesthesia - a Prospective,Observational Study
Overview
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.
Detailed description
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.
Primary outcome measures
- Time-frequency characteristics of electroencephalogram (EEG) [Time frame: during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)]
Secondary outcome measures (5)
- Modified observer's assessment of alertness#sedation#MOAA/S#scale [Time frame: during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)]
- Recovery time [Time frame: Within up to 30 minutes after operation]
- Pediatric anesthesia emergence delirium [Time frame: Within up to 30 minutes after operation]
- The Face, Legs, Activity, Cry, Consolability Scale (FLACC) [Time frame: Within up to 30 minutes after operation]
- PHBQ-AS [Time frame: 3 days after operation]
Eligibility criteria
Inclusion criteria
- aged 1 days#6 years#;
- with American Society of Anesthesiologists (ASA) physical status I or II#;
- children requiring general anesthesia under sevoflurane;
- parents or legal guardians of children who volunteered to participate in the trial; And signed the informed consent form.
Exclusion criteria
- Congenital malformation or other genetic conditions that are thought to affect brain development ;
- History of severe heart, brain, liver, kidney and metabolic diseases ;
- Premature infants (≤32 weeks);
- Upper respiratory tract infection in the last two weeks.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical Universit — Wenzhou
Identifiers
NCT: NCT06580028 · SAHoWMU-CR2024-03-217