Remiazolam Combined With Esketamine in Painless Bidirectional Endoscopy in Children

Not Applicable

Completed

• Conditions: Drug Effect
• Interventions: Drug: Esketamine; Drug: Remimazolam; Drug: Propofol; Drug: remifentanil

• Registration Number: NCT05686863
• Lead Sponsor: Tongji Hospital

Brief Summary

To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.

Detailed Description

It is planned to observe the painless two-way endoscopic examination of children in Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology from November 2022 to May 2023.To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.

Study Timeline

• Study First Submitted: 2023-01-07
• Study First Submitted QC: 2023-01-13
• Study First Posted: 2023-01-17
• Study Start: 2023-01-18
• Primary Completion: 2023-07-07
• Study Completion: 2023-07-07
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Age 0-17;
• ASA Class I-II;
• Sign the informed consent form.

Exclusion Criteria

• Patients with high risk of stomach satiety and reflux aspiration;
• Patients allergic to the study drug;
• Obesity or severe malnutrition;
• Those who have taken sedative, analgesic or antidepressant drugs within 24 hours;
• Hypertension without treatment;
• Abnormal liver and kidney function (index ≥ 2 times the upper limit of normal reference range);
• Other congenital diseases or acute and chronic diseases that affect the observation of curative effect;
• Participate in other clinical studies within 4 weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P group	Propofol	induction: Propofol 3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: propofol 5-10 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping
P group	remifentanil	induction: Propofol 3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: propofol 5-10 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping
P group	Esketamine	induction: Propofol 3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: propofol 5-10 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping
R group	Remimazolam	induction: Remimazolam 0.3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: Remimazolam 1-3 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping
R group	Esketamine	induction: Remimazolam 0.3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: Remimazolam 1-3 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping
R group	remifentanil	induction: Remimazolam 0.3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: Remimazolam 1-3 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping

Primary Outcome Measures

Name	Time	Method
Sedation success rate	Procedure (From the beginning of anesthesia to the end of examination)	Improved observer alertness and sedation score, MOAA/S

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China