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, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children.

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

Conditions
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Preoperative Sedation of Children

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 when they were randomized Subjects with a history of mental illness and a history of cognitive impairment epilepsy Subjects with cardiovascular disease Subjects whose hemoglobin is below the lower limit of normal Subjects with a history or possibility of a difficult airway Abnormal liver function and/or abnormal renal function Adrenoceptor agonists or antagonists or analgesics were used before randomization Participated in clinical trials (received experimental drugs) 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: Dexmedetomidine Hydrochloride Nasal Spray<br> | Drug: Dexmedetomidine Hydrochloride Nasal Spray<br>* In the low weight group, the subjects will receive a low dose of dexmedetomidine nasal spray. In the high weight group, the subjects will receive a high dose of dexmedetomidine nasal spray.<br>|
| Placebo Comparator: Dexmedetomidine hydrochloride nasal spray blank preparation<br> | Drug: Dexmedetomidine hydrochloride nasal spray blank preparation<br>* In the low weight group, the subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation. In the high weight group, the subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who meet parent-child separation successful |  | within 45 minutes after the beginning of administration | 
| Proportion of subjects who meet the Ramsay sedation score of 3 at least once within 45 minutes after the beginning of administration |  | within 45 minutes after the beginning of administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who meet parent-child separation successful within 45 minutes after the beginning of administration | The FUNK scale is a scale of 1 to 4 for sedation, anxiety, and separation from parents. Separation success is defined as a scale of 3 or 4 per item. | Within 45 minutes after the beginning of administration | 
| Time from the beginning of administration to the successful parent-child separation for the first time through study completion，an average of 3 days | The FUNK scale is a scale of 1 to 4 for sedation, anxiety, and separation from parents. Separation success is defined as a scale of 3 or 4 per item. | an average of 3 days | 
| Proportion of subjects whose the Ramsay score is satisfactory at least once within 45 minutes after the beginning of administration | Sedation level using the Ramsay scale. Ramsay Satisfaction is defined as a scale of ≥ 3. | Within 45 minutes after the beginning of administration | 
| Time from the beginning of administration to the satisfactory Ramsay score for the first time | Sedation level using the Ramsay scale. Ramsay Satisfaction is defined as a scale of ≥ 3. | from the beginning of administration to the first successful Ramsay score | 
| Proportion of subjects whose the UMSS Scale is satisfactory at least once within 45 minutes after the beginning of administration | Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction is defined as a scale of ≥ 2 . | within 45 minutes after the beginning of administration | 
| Time from the beginning of administration to the satisfactory UMSS score for the first time through study completion，an average of 3 days | Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction is defined as a scale of ≥ 2. | an average of 3 days | 
| Time of anesthesia awakening through study completion，an average of 3 days |  | an average of 3 days |