Pharmacokinetics Clinical Trial
Official title:
The SafetyćEfficacy and Pharmacokinetics of Dexmedetomidine Administered Through Different Routes in Pediatric
1. Acute Hemodynamic and respiratory Changes After Rapid Intravenous different doses of
Dexmedetomidine in Pediatric.
2. Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric.
3. Pharmacokinetics after a single dose of Dexmedetomidine administered as a nasal spray in
Pediatric.
| Status | Recruiting |
| Enrollment | 187 |
| Est. completion date | July 2019 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Years to 9 Years |
| Eligibility |
Inclusion Criteria: - selective operation of inguinal hernia repair?orthopedics operation or general surgery operation in children - aged 3-9 years - ASA I - II - enter the operating room by himself without parents - normal liver and kidney function - no history of anesthesia medication allergy. Exclusion Criteria: - allergic to dexmedetomidine, similar active ingredients or excipients - G-6-PD deficiency - a history of arrhythmia, bronchial and cardiovascular diseases, abnormal liver function and so on - a history of use of alpha 2 receptor agonists or antagonists. |
| Country | Name | City | State |
|---|---|---|---|
| China | The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
| Lead Sponsor | Collaborator |
|---|---|
| Chinese Medical Association |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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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