A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Adults

• Status: Active, not recruiting
• Trial end date: 2021-09-10
• Target enrollment: 0
• Participant gender: All

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 hydrochloride nasal spray for preoperative sedation.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

1. Able and willing to provide a written informed consent

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:

1. Not suitable for nasal spray

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