The EEG Study Under Remimazolam Anesthesia in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Electroencephalography, Remimazolam, Child Neglect. Basic parameters: 1 year — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Electroencephalogram Study in Children Under Remimazolam Anesthesia - a Prospective,Observational Study
Overview
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).
Primary outcome measures
- Time-frequency characteristics of electroencephalogram (EEG) [Time frame: Intraoperative (during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery)]
Secondary outcome measures (4)
- Modified observer's assessment of alertness/sedation (MOAA/S) [Time frame: Intraoperative (during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery)]
- Recovery time [Time frame: Within up to 30 minutes after operation]
- Pediatric anesthesia emergence delirium [Time frame: Within up to 30 minutes after operation]
- The Face, Legs, Activity, Cry, Consolability Scale (FLACC) [Time frame: Within up to 30 minutes after operation]
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
- 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. -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical Universit — Wenzhou
Identifiers
NCT: NCT06698705 · SAHoWMU-CR2024-03-221