Status:
UNKNOWN
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Adults
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Preoperative Sedation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in adults. To explore the reasonable dosage of dexmedetomidine ...
Eligibility Criteria
Inclusion
- Able and willing to provide a written informed consent
- Subjects requiring elective general anesthesia surgery
- Male or female
- Meet the weight standard
- Conform to the ASA Physical Status Classification
Exclusion
- Not suitable for nasal spray
- Subjects who had received general anesthesia
- Subjects with a history of myocardial infarction or unstable angina pectoris
- Subjects with atrioventricular block or cardiac insufficiency
- Subjects with a history of ischemic stroke or transient ischemic attack
- Subjects with poor blood pressure control after medication
- Subjects with abnormal clotting function
- Subjects with a history of mental illness and a history of cognitive impairment epilepsy
- Subjects with a history or possibility of a difficult airway
- Subject with a history of substance abuse and drug abuse
- Adrenoceptor agonists or antagonists were used before randomization
- Abnormal values in the laboratory
- Thyroid dysfunction
- Allergic to a drug ingredient or component
- Pregnant or nursing women
- No birth control during the specified period of time
- Participated in clinical trials of other drugs (received experimental drugs)
- The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Key Trial Info
Start Date :
May 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2021
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT04383418
Start Date
May 31 2020
End Date
September 10 2021
Last Update
July 15 2021
Active Locations (1)
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1
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032