Pharmacodynamics and Pharmacokinetics of Dexmedetomidine in Pediatric

Study Overview
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Brief Summary
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Acute Hemodynamic and respiratory Changes After Rapid Intravenous different doses of Dexmedetomidine in Pediatric. Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric. Pharmacokinetics after a single dose of Dexmedetomidine administered as a nasal spray in Pediatric.

Official Title
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The Safety、Efficacy and Pharmacokinetics of Dexmedetomidine Administered Through Different Routes in Pediatric

Conditions
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Pediatrics, Dexmedetomidine, Pharmacodynamics, Pharmacokinetics

Intervention / Treatment
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* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: group 1.1<br>Normal saline group | Drug: Dexmedetomidine<br>* see arms<br>|
| Experimental: group 1.2<br>0.25μg/kg dexmedetomidine group | Drug: Dexmedetomidine<br>* see arms<br>|
| Experimental: group 1.3<br>0.5μg/kg dexmedetomidine group | Drug: Dexmedetomidine<br>* see arms<br>|
| Experimental: group 1.4<br>0.75μg/kg dexmedetomidine group | Drug: Dexmedetomidine<br>* see arms<br>|
| Experimental: group 1.5<br>1.0μg/kg dexmedetomidine group | Drug: Dexmedetomidine<br>* see arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, pediatrics, Pharmacodynamics, Pharmacokinetics