Clinical trial NCT04200235: A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
Official title: Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Preoperative Sedation
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-12-16
Enrollment: 48
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dexmedetomidine hydrochloride nasal spray compared with placebo
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children


Eligibility 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 were randomized
4. Subjects with mental disorders and cognitive impairment；Subject with a history of epilepsy
5. Subjects with previous abnormal behavior after medication
6. Subjects with cardiovascular disease
7. Clinically significant abnormal clinical laboratory test value
8. Subjects whose hemoglobin is below the lower limit of normal
9. Subjects who have either an adrenergic receptor agonist or an antagonist were randomized
10. Participated in clinical trials of other drugs before screening (accepted experimental drugs)
11. A history or possibility of difficult airway
12. History of hypersensitivity to drug ingredients or components
13. Other circumstances that the investigator judged inappropriate for participation in this clinical trial

Primary outcomes:
measure: PK Cmax
timeFrame: 0 to 1 hour after administration
Secondary outcomes:
measure: Proportion of subjects who parent-child separation successful
timeFrame: 0 minute to 45 minutes after administration: every 15 minutes after administration
measure: Proportion of subjects who the Ramsay score is satisfactory at least once
timeFrame: 0 minute to 45 minutes after administration: every 5 minutes after administration
measure: Proportion of subjects who the UMSS Scale is satisfactory at least once
timeFrame: 0 minute to 45 minutes after administration: every 5 minutes after administration
measure: Total consumption of propofol(mg) during general anesthesia
timeFrame: From the beginning of anesthesia to the end of surgical operation up to 4 hours
measure: Total consumption of opioid analgesic(μg) during general anesthesia
timeFrame: From the beginning of anesthesia to the end of surgical operation up to 4 hours
measure: Time of anesthesia awakening
timeFrame: Up to 4 hours after the end of surgical operation
measure: Proportion of subjects with postoperative agitation
timeFrame: Up to 4 hours after the end of surgical operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing children's hospital, capital medical university
state: Beijing
Study officials:
References: