Effect of Esketamine on 95% Induction Dose of Remimazolam

Sedation Clinical Trial

— EEIDR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06303037
• Other study ID #: SAHoWMU-CR2024-03-105
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2024
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: Huacheng Liu
• Phone: 13957770577
• Email: huachengliu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• ED95
• Gastroscopy
• Pediatric
• Sedation

Intervention

Drug:
• Remimazolam besylate and low-dose Esketamine
Esketamine was injected intravenously 0.25mg/kg and the initial dose of Remimazolam was 0.3mg/kg
• Remimazolam besylate and Medium dose Esketamine
Esketamine was injected intravenously 0.5mg/kg and the initial dose of Remimazolam was 0.2mg/kg

Locations

Country	Name	City	State
China	The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation induction time	the patients' unresponsiveness to the mild shaking of their shoulder	during anaesthetic induction
Secondary	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
Secondary	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
Secondary	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
Secondary	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.