A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Adults
NCT ID: NCT04383418
Last Updated: 2021-07-15
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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UNKNOWN
PHASE2/PHASE3
201 participants
INTERVENTIONAL
2020-05-31
2021-09-10
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 dose group
In the low dose group, 36 subjects will receive a low dose of dexmedetomidine nasal spray.
dexmedetomidine nasal spray
dexmedetomidine nasal spray
Low dose group
In the high dose group, 36 subjects will receive a high dose of dexmedetomidine nasal spray.
dexmedetomidine nasal spray
dexmedetomidine nasal spray
Placebo group
In the placebo group，36 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.
dexmedetomidine hydrochloride nasal spray blank preparation
dexmedetomidine hydrochloride nasal spray blank preparation
Interventions
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dexmedetomidine nasal spray
dexmedetomidine nasal spray
dexmedetomidine hydrochloride nasal spray blank preparation
dexmedetomidine hydrochloride nasal spray blank preparation
Eligibility Criteria
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Inclusion Criteria
2. Subjects requiring elective general anesthesia surgery
3. Male or female
4. Meet the weight standard
5. Conform to the ASA Physical Status Classification
Exclusion Criteria
2. Subjects who had received general anesthesia
3. Subjects with a history of myocardial infarction or unstable angina pectoris
4. Subjects with atrioventricular block or cardiac insufficiency
5. Subjects with a history of ischemic stroke or transient ischemic attack
6. Subjects with poor blood pressure control after medication
7. Subjects with abnormal clotting function
8. Subjects with a history of mental illness and a history of cognitive impairment epilepsy
9. Subjects with a history or possibility of a difficult airway
10. Subject with a history of substance abuse and drug abuse
11. Adrenoceptor agonists or antagonists were used before randomization
12. Abnormal values in the laboratory
13. Thyroid dysfunction
14. Allergic to a drug ingredient or component
15. Pregnant or nursing women
16. No birth control during the specified period of time
17. Participated in clinical trials of other drugs (received experimental drugs)
18. The inestigators determined that other conditions were inappropriate for participation in this clinical trial
18 Years
65 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Changhong Miao, PhD
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Hospital, Fudan University, Shanghai
Locations
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Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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HR0171401-301
Identifier Type: -
Identifier Source: org_study_id
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