A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children

Study Overview
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Brief Summary
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The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children

Official Title
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Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Children

Conditions
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Preoperative Sedation

Intervention / Treatment
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* Drug: Dexmedetomidine hydrochloride nasal spray
* Drug: Dexmedetomidine hydrochloride nasal spray blank preparation.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to provide a written informed consent Male or female Subjects requiring elective general anesthesia surgery Conform to the ASA Physical Status Classification Meet the weight standard Exclusion Criteria: Not suitable for nasal spray Pediatric populations requiring special care or court/social welfare supervision Subjects who had been under general anesthesia were randomized Subjects with mental disorders and cognitive impairment；Subject with a history of epilepsy Subjects with previous abnormal behavior after medication Subjects with cardiovascular disease Clinically significant abnormal clinical laboratory test value Subjects whose hemoglobin is below the lower limit of normal Subjects who have either an adrenergic receptor agonist or an antagonist were randomized Participated in clinical trials of other drugs before screening (accepted experimental drugs) A history or possibility of difficult airway History of hypersensitivity to drug ingredients or components Other circumstances that the investigator judged inappropriate for participation in this clinical trial

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 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: Dexmedetomidine hydrochloride nasal spray compared with placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High weight group<br>High weight group | Drug: Dexmedetomidine hydrochloride nasal spray<br>* In the low weight group, 18 subjects will receive a low dose of dexmedetomidine nasal spray. In the high weight group, 18 subjects will receive a high dose of dexmedetomidine nasal spray.<br>Drug: Dexmedetomidine hydrochloride nasal spray blank preparation.<br>* In the low weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation. In the high weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.<br>* Other names: Placebo;|
| Experimental: Low weight group<br>Low weight group | Drug: Dexmedetomidine hydrochloride nasal spray<br>* In the low weight group, 18 subjects will receive a low dose of dexmedetomidine nasal spray. In the high weight group, 18 subjects will receive a high dose of dexmedetomidine nasal spray.<br>Drug: Dexmedetomidine hydrochloride nasal spray blank preparation.<br>* In the low weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation. In the high weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK Cmax | Maximum blood concentration (Cmax) | 0 to 1 hour after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who parent-child separation successful | The FUNK scale is a scale of 1 to 4 for sedation, anxiety, and separation from parents. Separation success defined as a scale of 3 or 4 per item. | 0 minute to 45 minutes after administration: every 15 minutes after administration | 
| Proportion of subjects who the Ramsay score is satisfactory at least once | Sedation level using the Ramsay scale. Ramsay Satisfaction defined as a scale of 2, 3, or 4; | 0 minute to 45 minutes after administration: every 5 minutes after administration | 
| Proportion of subjects who the UMSS Scale is satisfactory at least once | Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction defined as a scale of 3, 4, 5, or 6; | 0 minute to 45 minutes after administration: every 5 minutes after administration | 
| Total consumption of propofol(mg) during general anesthesia | Total consumption of propofol(mg) during general anesthesia | From the beginning of anesthesia to the end of surgical operation up to 4 hours | 
| Total consumption of opioid analgesic(μg) during general anesthesia | Total consumption of opioid analgesic(μg) during general anesthesia | From the beginning of anesthesia to the end of surgical operation up to 4 hours | 
| Time of anesthesia awakening | Time of anesthesia awakening | Up to 4 hours after the end of surgical operation | 
| Proportion of subjects with postoperative agitation | Proportion of subjects with postoperative agitation | Up to 4 hours after the end of surgical operation |