Clinical trial NCT06580028: The EEG Study Under Sevoflurane Anesthesia in Children
Official title: Electroencephalogram Study in Children Under Sevoflurane Anesthesia - a Prospective,Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Electroencephalography
Sevoflurane
Child Neglect
Keywords: Sevoflurane
Children
Electroencephalogram
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 280
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population met the above inclusion criteria.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. aged 1 days#6 years#;
2. with American Society of Anesthesiologists (ASA) physical status I or II#;
3. children requiring general anesthesia under sevoflurane;
4. parents or legal guardians of children who volunteered to participate in the trial; And signed the informed consent form.

Exclusion Criteria:

1. Congenital malformation or other genetic conditions that are thought to affect brain development ;
2. History of severe heart, brain, liver, kidney and metabolic diseases ;
3. Premature infants (≤32 weeks);
4. Upper respiratory tract infection in the last two weeks.

Primary outcomes:
measure: Time-frequency characteristics of electroencephalogram (EEG)
timeFrame: during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)
Secondary outcomes:
measure: Modified observer's assessment of alertness#sedation#MOAA/S#scale
timeFrame: during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)
measure: Recovery time
timeFrame: Within up to 30 minutes after operation
measure: Pediatric anesthesia emergence delirium
timeFrame: Within up to 30 minutes after operation
measure: The Face, Legs, Activity, Cry, Consolability Scale (FLACC)
timeFrame: Within up to 30 minutes after operation
measure: PHBQ-AS
timeFrame: 3 days after operation
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Huacheng Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Yuhang Cai
role: PRINCIPAL_INVESTIGATOR
References: