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

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• 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 children.

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

Details

• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

1. Able and willing to provide a written informed consent

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:

1. Not suitable for nasal spray

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