Clinical trial NCT06698705: The EEG Study Under Remimazolam Anesthesia in Children
Official title: Electroencephalogram Study in Children Under Remimazolam Anesthesia - a Prospective,Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Electroencephalography
Remimazolam
Child Neglect
Keywords: Electroencephalography
Remimazolam
children
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children were aged 1 years-12 years; with American Society of Anesthesiologists (ASA) physical status I or II; and requiring general anesthesia under remimazolam;

Brief summary: The effect of Remimazolam on brain electrical activity. Previous studies have shown that in healthy male volunteers, EEG changes during Remimazolam infusion are characterized by an initial increase in the beta band and a later increase in the delta band. When monitoring the depth of anesthesia, the commonly used Bispectral Index in clinical practice was originally developed for propofol. Therefore, studies have shown that the correlation between the depth of sedation of benzodiazepines such as midazolam and Bispectral Index is weak. In contrast, the beta wave ratio is considered a more suitable EEG indicator for monitoring the sedative effect of Remimazolam. The above indicates that Remimazolam has a specific pattern of influence on EEG activity, especially in the regulation of anesthesia depth, with unique characteristics.

Detailed description: This study is a prospective, observational study.Children undergoing elective general anesthesia with Remimazolam will be divided into three groups (1-3 years old, 4-6 years old, 7-12 years old) based on their age range, with 20 cases in each group.Inform the family of the general research plan and obtain informed consent. Main outcome measure: Time frequency characteristics of electroencephalography (EEG) in children of different age groups under general anesthesia withRemimazolam (including anesthesia induction, maintenance, and recovery periods).

Eligibility criteria: Inclusion Criteria:

1. aged 1 years-12 years; 2, with American Society of Anesthesiologists (ASA) physical status I or II; 3, children requiring general anesthesia under remimazolam; 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: Intraoperative (during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery)
Secondary outcomes:
measure: Modified observer's assessment of alertness/sedation (MOAA/S)
timeFrame: Intraoperative (during remimazolam 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
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: