The EEG Study Under Remimazolam Anesthesia in Children

Electroencephalogram Study in Children Under Remimazolam Anesthesia - a Prospective,Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Electroencephalography; Remimazolam; Child Neglect

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).

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Yuhang Cai; Phone Number: 18815091585; Email: 838097626@qq.com
• Study Contact Backup: Name: Huacheng Liu; Phone Number: 13957770577; Email: huachengliu@163.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • Recruiting
      • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
      • Contact: Yuhang Cai; Phone Number: 18815091585; Email: 838097626@qq.com
      • Contact: Huacheng Liu; Phone Number: 13957770577; Email: huachengliu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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;

Description

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. -

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time	From the time sevoflurane was stopped until the child opened his eyes for the first time and reached an Aldrete score of ≥9	Within up to 30 minutes after operation
Modified observer's assessment of alertness/sedation (MOAA/S)	5#Subject responds readily to name spoken in a normal tone; 4 #Lethargic response of a subject to a name spoken in a normal tone; 3 #The subject responds only after a name is called loudly and repeatedly; 2 #The subject responds only after mild prodding or shaking; 1 #The subject responds only after a painful trapezius squeeze; 0 #The subject does not respond to painful trapezius squeeze. MOAA/S score ≤ 2 points represent successful sedation	Intraoperative (during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery)
Pediatric anesthesia emergence delirium	The pediatric anesthesia emergence delirium scale consists of four items. Each item is scored 0-4 yielding a total between 0 and 20. The degree of emergence delirium increased directly with the total score.	Within up to 30 minutes after operation
The Face, Legs, Activity, Cry, Consolability Scale (FLACC)	The FLACC scale consists of five items. Each item is scored 0-2 yielding a total between 0 and 10. The degree of pain increased directly with the total score.	Within up to 30 minutes after operation

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Investigators: Principal Investigator: Huacheng Liu, Second Affiliated Hospital of Wenzhou Medical University; Principal Investigator: Yuhang Cai, Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: children; Electroencephalography; Remimazolam
• Other Study ID Numbers: SAHoWMU-CR2024-03-221

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No