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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1.1 | Sham Comparator | Normal saline group |
|
| group 1.2 | Experimental | 0.25μg/kg dexmedetomidine group |
|
| group 1.3 | Experimental | 0.5μg/kg dexmedetomidine group |
|
| group 1.4 | Experimental | 0.75μg/kg dexmedetomidine group |
|
| group 1.5 | Experimental | 1.0μg/kg dexmedetomidine group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | see arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Hemodynamic and respiratory Changes After Rapid Intravenous of Dexmedetomidine | Acute Hemodynamic and respiratory Changes After Rapid Intravenous different doses of Dexmedetomidine in Pediatric | up to 4 months |
| Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric | After a single Rapid Intravenous dose of Dexmedetomidine in Pediatric，blood samples will be collected ,and dexmedetomidine plasma concentrations were measured with High Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS). | up to 6 months |
| Pharmacokinetics of Dexmedetomidine administered as a nasal spray | After a single dose of Dexmedetomidine administered as a nasal spray in Pediatric,blood samples will be collected ,and dexmedetomidine plasma concentrations were measured with High Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS). | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Chen | Contact | +86 13957776300 | 15254896@qq.com | |
| Chengyu Wang | Contact | +8615158719196 | 15158719196@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huacheng Liu | Second Affiliated Hospital of Wenzhou Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325027 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2017 | Oct 13, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 12, 2017 | Oct 13, 2017 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 12, 2017 | Oct 13, 2017 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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