Second Affiliated Hospital of Wenzhou Medical University
Phase
Observational
Started
2024-11-22
Last updated
2025-02-06
Condition(s) studied
ElectroencephalographyRemimazolamChild Neglect
Study 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.
Eligibility
Sex
ALL
Min age
1 Year
Max age
12 Years
Healthy volunteers
No
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 outcome measure(s)
Time-frequency characteristics of electroencephalogram (EEG) — Intraoperative (during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery) Time-frequency characteristics of electroencephalogram (EEG) in children of different ages during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery) .
Trial sites (1)
Facility
City
Region
Status
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou
Zhejiang
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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