A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
NCT ID: NCT04200235
Last Updated: 2020-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2020-01-06
2020-08-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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High weight group
High weight group
Dexmedetomidine hydrochloride nasal spray
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.
Dexmedetomidine hydrochloride nasal spray blank preparation.
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.
Low weight group
Low weight group
Dexmedetomidine hydrochloride nasal spray
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.
Dexmedetomidine hydrochloride nasal spray blank preparation.
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.
Interventions
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Dexmedetomidine hydrochloride nasal spray
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.
Dexmedetomidine hydrochloride nasal spray blank preparation.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female
3. Subjects requiring elective general anesthesia surgery
4. Conform to the ASA Physical Status Classification
5. Meet the weight standard
Exclusion Criteria
2. Pediatric populations requiring special care or court/social welfare supervision
3. Subjects who had been under general anesthesia were randomized
4. Subjects with mental disorders and cognitive impairment；Subject with a history of epilepsy
5. Subjects with previous abnormal behavior after medication
6. Subjects with cardiovascular disease
7. Clinically significant abnormal clinical laboratory test value
8. Subjects whose hemoglobin is below the lower limit of normal
9. Subjects who have either an adrenergic receptor agonist or an antagonist were randomized
10. Participated in clinical trials of other drugs before screening (accepted experimental drugs)
11. A history or possibility of difficult airway
12. History of hypersensitivity to drug ingredients or components
13. Other circumstances that the investigator judged inappropriate for participation in this clinical trial
2 Years
6 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing children's hospital, capital medical university
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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HR0171401-102
Identifier Type: -
Identifier Source: org_study_id
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