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NCT Number: NCT06061159

The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction

Due to the incomplete development of systems and low pain thresholds in the pediatric population, good general anesthesia is required during the perioperative period to ensure the smooth progress of the surgery.Propofol is often used for anesthesia induction in clinical work, which can achieve good anesthesia effects. However, this drug has obvious injection pain and is prone to significant inhibition of blood circulation, and may even lead to adverse conditions such as respiratory depression in children. For the pediatric population, maintaining appropriate anesthesia depth and stable circulation during the induction period of general anesthesia has always been a focus of attention and research by anesthesiologists.Remimazolam besylate is a new type of water-soluble ultra short acting benzodiazepine drug that is hydrolyzed and metabolized by plasma esterase in the body, independent of liver and kidney function, and the metabolite zolam propionic acid has no pharmacological activity; Rapid onset and failure, short sedation recovery time; Has little impact on respiration and circulation; And there is no injection pain.Remazolam besylate is highly suitable for children due to its characteristics, and some studies have demonstrated the safety of intravenous injection of Remazolam besylate. However, there is limited research on its dosage exploration, which to some extent limits its clinical application in children.This study aims to explore the 95% effective dose (ED95) of single intravenous injection of remidazolam besylate in children of different age groups, providing a theoretical basis for the use of remidazolam besylate in pediatric anesthesia.

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Key information

Conditions

Pediatric ED95 General Anesthesia Sedation

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Wenzhou, Zhejiang, China

About this study

This experiment was divided into three groups based on the age of the children, namely 1-3 years old, 4-6 years old, 7-12 years old, with an initial dose of 0.2mg/kg. The time of consciousness loss in the children was evaluated after injection of ramazolam besylate to determine whether sedation had been achieved. The next dose was adjusted to 0.05mg/kg according to biased coin design,to further explore the ED95 of a single intravenous injection of ramazolam in children of different age groups.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • with American Society of Anesthesiologists (ASA) physical status I or II；
  • aged 1-12 years；
  • children with weight for age within the normal range；
  • were scheduled general anesthesia surgery

Exclusion criteria

  • Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
  • contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to remimazolam;
  • recently respiratory infection, mental disorder;
  • other reasons that researchers hold it is not appropriate to participate in this trial.

Treatment and study plan

Remimazolam besylate

Drug

initial dose is 0.2mg/kg；adjust dosage is 0.05mg/kg

Other names: single intravenous bolus remimazolam according to biased coin design

Primary outcomes

  1. the time of the loss of consciousness(LOC)

    Time frame: during anaesthetic induction

    Modified Observers Assessment of Alertness/Sedation (MOAA/S) score of 1 or deeper within 1 minute, and maintained until the end of the 5-minute observation period.

Secondary outcomes

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

    Time frame: Every 1 minutes after single intravenous bolus remimazolam

    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 ≤ 1 points represent successful sedation

  2. BIS

    Time frame: Every 1 minutes after single intravenous bolus remimazolam

    BIS values range from 0 to 100. A value of 0 represents the absence of brain activity, and 100 represents the awake state.

    BIS values between 60 to 80 represent sedation; BIS values between 40 to 60 represent adequate general anesthesia for a surgery; values less than 40 represent a deep hypnotic state.

  3. Recovery time

    Time frame: Within up to 30 minutes after child's first eye opening in the postoperative period

    The time from discontinuation of sevoflurane to the first open eye of the children and to achieve the modified aldrete scole ≥9.

    then the aldrete scole's minimum value is 0 and maximum value is 10, and higher scores mean a better or outcome.

    The modified aldrete scole consists of five items. Each item is scored 0-2 yielding a total between 0 and 10.

  4. Number of children with adverse effects

    Time frame: Up to 24 hours including preoperative, intraoperative, and postoperative periods

    Number of children with adverse effects:

    １、Bradycardia and/or hypotension need for hemodynamic support; 2、Desaturation is defined as Oxygen desaturation <90%; 3、Nausea and vomiting; 4、Any adverse effects requiring interventions.

  5. Rate of Pediatric anesthesia emergence delirium

    Time frame: Within up to 15-30 minutes after child's first eye opening in the postoperative period

    The pediatric anesthesia emergence delirium scale consists of five 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. pediatric anesthesia emergence delirium scale ≥12 at any time indicates presence of emergence delirium.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction:a Randomised,Double-blind Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2023
Registry last updated
Feb 7, 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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