Preoperative Sedation
Conditions
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
Interventions
In the low weight group, 18 subjects will receive a low dose of dexmedetomidine nasal spray. In the high weight group, 18 subjects will receive a high dose of dexmedetomidine nasal spray.
DRUGDexmedetomidine hydrochloride nasal spray blank preparation.
In the low weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation. In the high weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Dexmedetomidine hydrochloride nasal spray compared with placebo
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK Cmax | 0 to 1 hour after administration | Maximum blood concentration (Cmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects who the Ramsay score is satisfactory at least once | 0 minute to 45 minutes after administration: every 5 minutes after administration | Sedation level using the Ramsay scale. Ramsay Satisfaction defined as a scale of 2, 3, or 4; |
| Proportion of subjects who the UMSS Scale is satisfactory at least once | 0 minute to 45 minutes after administration: every 5 minutes after administration | Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction defined as a scale of 3, 4, 5, or 6; |
| Total consumption of propofol(mg) during general anesthesia | From the beginning of anesthesia to the end of surgical operation up to 4 hours | Total consumption of propofol(mg) during general anesthesia |
| Proportion of subjects who parent-child separation successful | 0 minute to 45 minutes after administration: every 15 minutes after administration | The FUNK scale is a scale of 1 to 4 for sedation, anxiety, and separation from parents. Separation success defined as a scale of 3 or 4 per item. |
| Time of anesthesia awakening | Up to 4 hours after the end of surgical operation | Time of anesthesia awakening |
| Proportion of subjects with postoperative agitation | Up to 4 hours after the end of surgical operation | Proportion of subjects with postoperative agitation |
| Total consumption of opioid analgesic(μg) during general anesthesia | From the beginning of anesthesia to the end of surgical operation up to 4 hours | Total consumption of opioid analgesic(μg) during general anesthesia |
Countries
China
Outcome results
None listed