The EEG Study Under Remimazolam Anesthesia in Children

NCT06698705 | Recruiting DMC

• 1 other identifier: SAHoWMU-CR2024-03-221
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Electroencephalography; Remimazolam; Child Neglect

Keywords

Electroencephalography; Remimazolam; children

Outcome Measures

Primary Outcomes (1)

• Time-frequency characteristics of electroencephalogram (EEG)

  Time-frequency characteristics of electroencephalogram (EEG) in children of different ages during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery) .

  Intraoperative (during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery)

Secondary Outcomes (4)

• Modified observer's assessment of alertness/sedation (MOAA/S)

  Intraoperative (during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery)

• Recovery time

  Within up to 30 minutes after operation

• Pediatric anesthesia emergence delirium

  Within up to 30 minutes after operation

• The Face, Legs, Activity, Cry, Consolability Scale (FLACC)

  Within up to 30 minutes after operation

Study Arms (3)

1-3 years

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

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

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.

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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;

You may qualify if:

• \. 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

Study Officials

• Huacheng Liu

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Yuhang Cai

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huacheng Liu

CONTACT

13957770577; huachengliu@163.com

Yuhang Cai

CONTACT

18815091585; 838097626@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: November 22, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

CN (1)