Dose of Remimazolam in Children for Intubation

Study Overview
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Brief Summary
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Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl in pediatric patients is still unknown.

Official Title
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Half Effective Dose of Remimazolam to Prevent Cardiovascular Response to Tracheal Intubation When Combined With Fentanyl

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Remimazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age from 3 to 12 years old patients scheduled for surgery under general anesthesia Body mass index in the range of 5% -95% of the same age group Consent was obtained from the patient and the family members, and an informed consent form was signed Exclusion Criteria: American Society of Anesthesiologists status ≥3 patients who cannot cooperate with intravenous anesthesia induction patients with risk of difficult airway patients who are allergic to benzodiazepines patients with neurological dysfunction Participate involved in other clinical investigators within 3 months

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 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
Intervention Model: Sequential Assignment
Interventional Model Description: The initial dose is 0.4mg/kg and the dose interval is 0.2mg/kg
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: remimazolam<br>Remimazolam is given for anesthesia induction. The initial dosage is 0.4mg/kg, and the interval dosage is 0.02mg/kg. | Drug: Remimazolam<br>* remimazolam is given intravenously<br>* Other names: remimazolam besylate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| half effective dose for intubation | half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl | from injection of remimazolam to completed tracheal intubation, at an average of 5 minutes | 
| cardiovascular response to tracheal intubation | cardiovascular response is defined as increase of blood pressure or heart rate higher than 20% of the baseline value by 3 minutes after intubation | from injection of remimazolam to 3 minutes after tracheal intubation, at an average of 8 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time to loss of consciousness |  | from injection of remimazolam to loss of consciousness, at an average of 3 minutes | 
| incidence of adverse events | adverse events include bradycardia, hypotension, hypoxemia, and injection pain | from injection of remimazolam to loss of consciousness, at an average of 3 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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median effective dose, anesthesia induction, remimazolam, tracheal intubation