Effect of Esketamine on 95% Induction Dose of Remimazolam (EEIDR)

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

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.

Study Overview

• Status: Completed
• Conditions: Sedation; Pediatric; Gastroscopy; ED95
• Intervention / Treatment: Drug: Remimazolam besylate and low-dose Esketamine; Drug: Remimazolam besylate and Medium dose Esketamine

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group L; Low-dose esketamine	Drug: Remimazolam besylate and low-dose Esketamine; 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
Experimental: Group M; Medium dose esketamine	Drug: Remimazolam besylate and Medium dose Esketamine; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation induction time	the patients' unresponsiveness to the mild shaking of their shoulder	during anaesthetic induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery times	The time from discontinuation of anesthesia drug to the first open eye of the children and to achieve aldrete≥9	Within up to 30 minutes after operation
Modified observer's assessment of alertness#sedation#MOAA/S#scale	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	1 minutes after single intravenous bolus remimazolam
VAS(The difficulty of gastroscope 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.	Moment of endoscopic insertion
Number of children with adverse effects	Bradycardia and/or hypotension need for hemodynamic support Desaturation is defined as Oxygen desaturation <90% Any adverse effects requiring interventions	Within 24 hours after completion of gastroscopy.

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; Principal Investigator: Qiaoqiao Wang, Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): August 29, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 12, 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: esketamine; remimazolam
• Additional Relevant MeSH Terms: Psychotropic Drugs; Antidepressive Agents; Esketamine
• Other Study ID Numbers: SAHoWMU-CR2024-03-105

Drug and device information, study documents

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