Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High weight group | Experimental | High weight group |
|
| Low weight group | Experimental | Low weight group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine hydrochloride nasal spray | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PK Cmax | Maximum blood concentration (Cmax) | 0 to 1 hour after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who parent-child separation successful | 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. | 0 minute to 45 minutes after administration: every 15 minutes after administration |
| Proportion of subjects who the Ramsay score is satisfactory at least once |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing children's hospital, capital medical university | Beijing | Beijing Municipality | 100045 | China |
Not provided
Dexmedetomidine hydrochloride nasal spray compared with placebo
Not provided
Not provided
Not provided
| Dexmedetomidine hydrochloride nasal spray blank preparation. | Drug | 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. |
|
|
Sedation level using the Ramsay scale. Ramsay Satisfaction defined as a scale of 2, 3, or 4; |
| 0 minute to 45 minutes after administration: every 5 minutes after administration |
| Proportion of subjects who the UMSS Scale is satisfactory at least once | Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction defined as a scale of 3, 4, 5, or 6; | 0 minute to 45 minutes after administration: every 5 minutes after administration |
| Total consumption of propofol(mg) during general anesthesia | 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 opioid analgesic(μg) during general anesthesia | Total consumption of opioid analgesic(μg) during general anesthesia | From the beginning of anesthesia to the end of surgical operation up to 4 hours |
| Time of anesthesia awakening | Time of anesthesia awakening | Up to 4 hours after the end of surgical operation |
| Proportion of subjects with postoperative agitation | Proportion of subjects with postoperative agitation | Up to 4 hours after the end of surgical operation |