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NCT Number: NCT06580028

The EEG Study Under Sevoflurane Anesthesia in Children

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.

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Key information

Conditions

Electroencephalography Child Neglect Sevoflurane

Age range

1 day–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Time-frequency characteristics of electroencephalogram (EEG)

    Time frame: during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)

    Time-frequency characteristics of electroencephalogram (EEG) in children of different ages during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery) .

Secondary outcomes

  1. Modified observer's assessment of alertness#sedation#MOAA/S#scale

    Time frame: during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)

    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

  2. Recovery time

    Time frame: Within up to 30 minutes after operation

    From the time sevoflurane was stopped until the child opened his eyes for the first time and reached an Aldrete score of ≥9

  3. Pediatric anesthesia emergence delirium

    Time frame: Within up to 30 minutes after operation

    The pediatric anesthesia emergence delirium scale consists of four items. Each item is scored 0-4 yielding a total between 0 and 20.

  4. The Face, Legs, Activity, Cry, Consolability Scale (FLACC)

    Time frame: Within up to 30 minutes after operation

    The FLACC scale consists of five items. Each item is scored 0-2 yielding a total between 0 and 10.

  5. PHBQ-AS

    Time frame: 3 days after operation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huacheng Liu

CONTACT

[email protected]

13957770577

Yuhang Cai

CONTACT

[email protected]

18815091585

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

Electroencephalogram Study in Children Under Sevoflurane Anesthesia - a Prospective,Observational Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2024
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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