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

Hengrui Medicine

Status and phase: Completed; Phase 3

Conditions: Preoperative Sedation of Children

Treatments: Drug: Dexmedetomidine hydrochloride nasal spray blank preparation; Drug: Dexmedetomidine Hydrochloride Nasal Spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT05111431

HR0171401-302

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 children.

Enrollment: 159 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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159 participants in 2 patient groups, including a placebo group

Dexmedetomidine Hydrochloride Nasal Spray

Experimental group

Treatment:

Drug: Dexmedetomidine Hydrochloride Nasal Spray

Dexmedetomidine hydrochloride nasal spray blank preparation

Placebo Comparator group

Treatment:

Drug: Dexmedetomidine hydrochloride nasal spray blank preparation