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

Hengrui Medicine

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Preoperative Sedation

Treatments: Drug: dexmedetomidine nasal spray; Drug: dexmedetomidine hydrochloride nasal spray blank preparation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04383418

HR0171401-301

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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201 participants in 3 patient groups, including a placebo group

High dose group

Experimental group

Description:

In the low dose group, 36 subjects will receive a low dose of dexmedetomidine nasal spray.

Treatment:

Drug: dexmedetomidine nasal spray

Low dose group

Experimental group

Description:

In the high dose group, 36 subjects will receive a high dose of dexmedetomidine nasal spray.

Treatment:

Drug: dexmedetomidine nasal spray

Placebo group

Placebo Comparator group

Description:

In the placebo group，36 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.

Treatment:

Drug: dexmedetomidine hydrochloride nasal spray blank preparation