ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children

Study Overview
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Brief Summary
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Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups.

Detailed Description
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Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups, providing a more scientific clinical dose selection basis for the anesthesia induction application of Remazolam.

Official Title
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The 90% Effective Dose (ED90) of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children: a Biased Coin up and Down Sequential Trial

Conditions
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Bidirectional Endoscopy

Intervention / Treatment
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* Drug: Remimazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 0-12 years old, ASA I-II level; Sign an informed consent form. Exclusion Criteria: Developmental delay or neurological and psychiatric disorders; Severe malnutrition or severe obesity; High risk of stomach fullness and reflux aspiration; Allergic to benzodiazepines and opioids; Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours; Severe sleep apnea; Abnormal liver and kidney function; Recently participated in other clinical studies.

Ages Eligible for Study
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Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0-3 years group<br>Age:<48 months | Drug: Remimazolam<br>* Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy<br>* Other names: Remimazolam besylate;|
| Experimental: 4-6 years group<br>Age: ≥48 and <84 months | Drug: Remimazolam<br>* Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy<br>* Other names: Remimazolam besylate;|
| Experimental: 7-12 years group<br>Age: ≥84and <156 months | Drug: Remimazolam<br>* Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy<br>* Other names: Remimazolam besylate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S | Using the modified MOAA/S scoring table（ranging from 5-0） to evaluate if the sedation is successful. 5 points：Respond quickly to names spoken in a normal tone 4 points：Showing a drowsy reaction to names spoken in a normal tone 3 points：Only react after loudly and/or repeatedly calling the name 2 points：Response immediately after slight stimulation or shaking 1point：Response only occurs after compression of the trapezius muscle that causes pain 0 point：No response after compression of the trapezius muscle | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory suppression incidence | Respiratory frequency<8 times/min or SP02<90% | 1 day | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Intraoperative blood pressure and heart rate changes: record the patient's intraoperative blood pressure, heart rate, and the use of related vasoactive drugs; Postoperative adverse reactions: such as hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness, etc. | 2 days | 
| Time records | Anesthesia time, induction time, surgical time, awakening time, and recovery time; | 1 day | 
| Use of drugs | The total amount of sedative and analgesic drugs used. | 1 day | 
| Postoperative pain assessment | Assess the patient's FLACC score(ranging from 0-10) at different time points (0 minutes after awakening, 10 minutes after awakening) and within 24 hours after surgery on the PACU (Postanesthesia care unit); The Flacc score divides the degree of pain into five parts: facial expression, leg activity, posture, crying, and comfort level. Each part is divided into three parts: 0, 1, and 2. The higher the score, the higher the degree of pain. The total score of the last five parts is the Flacc score, which ranges from 0 to 10 points. | 2 days | 
| Baxter Retching Faces (BARF) nausea scale | Assess PONV until discharge with the use of the Baxter Retching Faces (BARF) nausea scale. The BARF scale is a visual scale that draws six scales based on children's nausea and vomiting based on their facial expressions, representing 0 points (no nausea and vomiting), 2 points and 4 points (mild nausea and vomiting), 6 points and 8 points (severe nausea and vomiting), and 10 points (vomiting), respectively. | 2 days | 
| Sleep quality. | The sleep quality was assessed with a 3-point scale: 0=slept well, 1=woke up crying in the night, and 2=intermittent sleep. | 2 days | 
| Daily activities | Daily activity was evaluated using the following 3-point scale: 0=normal quality,1=depressed but performed normal daily activities, and 2=irritable and could not perform normal activities. | 2 days | 
| Parental satisfaction | Parental satisfaction was assessed with the 11-point numeric rating scale (NRS) ranging from 0 to 10, whereby a score of 10 indicated the highest satisfaction. | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric anesthesia, remimazolam, ED90