A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
NCT ID: NCT05111431
Last Updated: 2022-11-07
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
PHASE3
159 participants
INTERVENTIONAL
2021-11-24
2022-05-20
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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Dexmedetomidine Hydrochloride Nasal Spray
Dexmedetomidine Hydrochloride Nasal Spray
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.
Dexmedetomidine hydrochloride nasal spray blank preparation
Dexmedetomidine hydrochloride nasal spray blank preparation
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.
Interventions
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Dexmedetomidine Hydrochloride Nasal Spray
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.
Dexmedetomidine hydrochloride nasal spray blank preparation
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.
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 when they were randomized
4. Subjects with a history of mental illness and a history of cognitive impairment epilepsy
5. Subjects with cardiovascular disease
6. Subjects whose hemoglobin is below the lower limit of normal
7. Subjects with a history or possibility of a difficult airway
8. Abnormal liver function and/or abnormal renal function
9. Adrenoceptor agonists or antagonists or analgesics were used before randomization
10. Participated in clinical trials (received experimental drugs)
11. History of hypersensitivity to drug ingredients or components
12. Other circumstances that the investigator judged inappropriate for participation in this clinical trial
2 Years
6 Years
ALL
No
Sponsors
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Shanghai Hengrui Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Children's Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Countries
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References
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Gao J, Wang F, Wang X, Zou X, Liu HC, Song X, Chai X, Jiang R, Zhao P, Zhang J, Wang SY, Ma H, Zhao Z, Wang Q, Zhou N, Bai J, Zhang J. Safety and efficacy of a novel dexmedetomidine nasal spray for pre-anesthetic sedation in children: a randomized, double-blind, placebo-controlled trial. BMC Anesthesiol. 2024 Sep 6;24(1):315. doi: 10.1186/s12871-024-02708-1.
Other Identifiers
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HR0171401-302
Identifier Type: -
Identifier Source: org_study_id
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