Effect of Esketamine on 95% Induction Dose of Remimazolam

Phase 4

Completed

• Conditions: Pediatric; Gastroscopy; ED95; Sedation
• Interventions: Drug: Remimazolam besylate and low-dose Esketamine; Drug: Remimazolam besylate and Medium dose Esketamine

• Registration Number: NCT06303037
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-12
• Study Start: 2024-04-01
• Primary Completion: 2024-08-29
• Study Completion: 2024-12-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. with American Society of Anesthesiologists (ASA) physical status I or II#;
2. aged 3#12 years#;
3. children with weight for age within the normal range#;
4. were scheduled to have a gastroscopy;

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group L	Remimazolam besylate and low-dose Esketamine	Low-dose esketamine
Group M	Remimazolam besylate and Medium dose Esketamine	Medium dose esketamine

Primary Outcome Measures

Name	Time	Method
Sedation induction time	during anaesthetic induction	the patients' unresponsiveness to the mild shaking of their shoulder

Secondary Outcome Measures

Name	Time	Method
Modified observer's assessment of alertness#sedation#MOAA/S#scale	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
Recovery times	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
VAS(The difficulty of gastroscope insertion)	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.
Number of children with adverse effects	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

Trial Locations

Locations (1)

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China