Effect of Esketamine on 95% Induction Dose of Remimazolam

NCT06303037 | Completed Phase 4

• 1 other identifier: SAHoWMU-CR2024-03-105
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric; Gastroscopy; ED95; Sedation

Keywords

remimazolam; esketamine

Outcome Measures

Primary Outcomes (1)

• Sedation induction time

  the patients' unresponsiveness to the mild shaking of their shoulder

  during anaesthetic induction

Secondary Outcomes (4)

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

  1 minutes after single intravenous bolus remimazolam

• Recovery times

  Within up to 30 minutes after operation

• VAS(The difficulty of gastroscope insertion)

  Moment of endoscopic insertion

• Number of children with adverse effects

  Within 24 hours after completion of gastroscopy.

Study Arms (2)

Group L

EXPERIMENTAL

Low-dose esketamine

Drug: Remimazolam besylate and low-dose Esketamine

Group M

EXPERIMENTAL

Medium dose esketamine

Drug: Remimazolam besylate and Medium dose Esketamine

Interventions

Remimazolam besylate and low-dose Esketamine DRUG

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

Also known as: intravenous bolus remimazolam according to biased coin design

Group L

Remimazolam besylate and Medium dose Esketamine DRUG

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

Also known as: intravenous bolus remimazolam according to biased coin design

Group M

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

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

Wenzhou, Zhejiang, China

Location

MeSH Terms

Interventions

Esketamine

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: March 12, 2024
• Study Start: April 1, 2024
• Primary Completion: August 29, 2024
• Study Completion: December 1, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

CN (1)