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Completed

NCT Number: NCT06303037

Effect of Esketamine on 95% Induction Dose of Remimazolam

As an invasive operation, gastroscopy will cause children's nervousness, anxiety and uncooperative behavior, and even lead to the risk of bleeding and perforation, which will also affect the accuracy of the examination results.The purpose of this study is to explore the influence of different doses of esketamine on the induced dose ED95 of remazolam during gastroscopic placement in children, and to provide theoretical basis for the combined use of remimazolam besylate and esketamine in gastroscopic anesthesia in children.

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Key information

Conditions

Pediatric ED95 Gastroscopy Sedation

Age range

3 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

Children aged 3-12 who underwent gastroscopy were randomly divided into two groups: L group with Esketamine 0.25mg/kg and the initial dose of Remimazolam was 0.3mg/kg ,M group with Esketamine 0.5mg/kg and the initial dose of Remimazolam was 0.2mg/kg.Judging whether the sedation level of the children can meet the requirements of gastroscopy placement after injecting Remimazolam.The next dose was adjusted to 0.05mg/kg according to biased coin design,to further explore the induced dose of ED95 of Remimazolam under the background of different doses of Esketamine.

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 3#12 years#;
  • children with weight for age within the normal range#;
  • were scheduled to have a gastroscopy;

Exclusion criteria

  • Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
  • contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to remimazolam and esketamine;
  • 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 and low-dose Esketamine

Drug

Esketamine was injected intravenously 0.25mg/kg and the initial dose of Remimazolam was 0.3mg/kg

Other names: intravenous bolus remimazolam according to biased coin design

Remimazolam besylate and Medium dose Esketamine

Drug

Esketamine was injected intravenously 0.5mg/kg and the initial dose of Remimazolam was 0.2mg/kg

Other names: intravenous bolus remimazolam according to biased coin design

Primary outcomes

  1. Sedation induction time

    Time frame: during anaesthetic induction

    the patients' unresponsiveness to the mild shaking of their shoulder

Secondary outcomes

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

    Time frame: 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 ≤ 2 points represent successful sedation

  2. Recovery times

    Time frame: Within up to 30 minutes after operation

    The time from discontinuation of anesthesia drug to the first open eye of the children and to achieve aldrete≥9

  3. VAS(The difficulty of gastroscope insertion)

    Time frame: Moment of endoscopic insertion

    VAS values range from 0 to 10. A value of 0 represents that gastroscopy placement is very easy.and 10 represents that gastroscopy placement is very difficult.

  4. Number of children with adverse effects

    Time frame: Within 24 hours after completion of gastroscopy.

    Bradycardia and/or hypotension need for hemodynamic support Desaturation is defined as Oxygen desaturation <90% Any adverse effects requiring interventions

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

Determination of the 95% Effective Dose of Remimazolam in Combination With Different Doses of Esketamine During Gastroscopy in Children

Acronym: EEIDR

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 12, 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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