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NCT Number: NCT06698705

The EEG Study Under Remimazolam Anesthesia in Children

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.

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Key information

Conditions

Electroencephalography Child Neglect Remimazolam

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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. -

Treatment and study plan

Primary outcomes

  1. Time-frequency characteristics of electroencephalogram (EEG)

    Time frame: 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) .

Secondary outcomes

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

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

    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

  2. Recovery time

    Time frame: Within up to 30 minutes after operation

    From the time sevoflurane was stopped until the child opened his eyes for the first time and reached an Aldrete score of ≥9

  3. Pediatric anesthesia emergence delirium

    Time frame: Within up to 30 minutes after operation

    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.

  4. The Face, Legs, Activity, Cry, Consolability Scale (FLACC)

    Time frame: Within up to 30 minutes after operation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huacheng Liu

CONTACT

[email protected]

13957770577

Yuhang Cai

CONTACT

[email protected]

18815091585

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2024
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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