The EEG Study Under Sevoflurane Anesthesia in Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-6
SponsorSecond Affiliated Hospital of Wenzhou Medical University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study population met the above inclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
280 Participants
are grouped into 14 trial groups14
Trial groupsSee each trial group below.
Group A: 0-3 months
Group B: 3-6 months
Group C: 6-9 months
Group D: 9-12 months
Group E: 1-1.5 years
Group F: 1.5-2 years
Group G: 2-2.5 years
Group H: 2.5-3 years
Group I: 3-3.5 years
Group J: 3.5-4 years
Group K: 4-4.5 years
Group L: 4.5-5 years
Group M: 5-5.5 years
Group N: 5.5-6 years
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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 operation3
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 operation4
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 operationSponsors and contacts
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Source ClinicalTrials.gov