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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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