Remiazolam Combined With Esketamine in Painless Bidirectional Endoscopy in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sedative Effect and Safety of Remiazolam Combined With Low-dose Esketamine in Painless Bidirectional Endoscopy in Children

Conditions
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Drug Effect

Intervention / Treatment
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* Drug: Remimazolam
* Drug: Esketamine
* Drug: Propofol
* Drug: remifentanil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized controlled study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: P group<br>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 | Drug: Esketamine<br>* Esketamine<br>* Other names: Esket;Drug: Propofol<br>* Propofol<br>* Other names: Prop;Drug: remifentanil<br>* remifentanil<br>* Other names: remifen;|
| Experimental: R group<br>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 | Drug: Remimazolam<br>* Remazolam for sedation in children undergoing bidirectional endoscopy<br>* Other names: Rema;Drug: Esketamine<br>* Esketamine<br>* Other names: Esket;Drug: remifentanil<br>* remifentanil<br>* Other names: remifen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation success rate | Improved observer alertness and sedation score, MOAA/S | Procedure (From the beginning of anesthesia to the end of examination) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remiazolam, esketamine, bidirectional endoscopy, children