The EEG Study Under Remimazolam Anesthesia in Children

Second Affiliated Hospital of Wenzhou Medical University

Status: Enrolling

Conditions: Remimazolam; Electroencephalography; Child Neglect

Study type: Observational

Funder types: Other

Identifiers

NCT06698705

SAHoWMU-CR2024-03-221

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

60 participants in 3 patient groups

1-3 years

Description:

The child should wear EEG consumables accompanied by their family and be properly secured in the operating room. Induction and maintenance of Remimazolam, collection of EEG information . EEG collection covers the entire perioperative period, including preoperative awake period (or preoperative sedation period), surgical anesthesia period, and anesthesia awake period.

4-6 years

Description:

The child should wear EEG consumables accompanied by their family and be properly secured in the operating room. Induction and maintenance of Remimazolam, collection of EEG information . EEG collection covers the entire perioperative period, including preoperative awake period (or preoperative sedation period), surgical anesthesia period, and anesthesia awake period.

7-12 years

Description:

The child should wear EEG consumables accompanied by their family and be properly secured in the operating room. Induction and maintenance of Remimazolam, collection of EEG information . EEG collection covers the entire perioperative period, including preoperative awake period (or preoperative sedation period), surgical anesthesia period, and anesthesia awake period.