Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine

Study Overview
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Brief Summary
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the aim of this study is to study the pharmacokinetics and dynamics of nebulized dexmetedomidine in children undergoing major abdominal cancer surgery.

Detailed Description
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Inhalation of nebulized drug is an alternative route of administration that is relatively easy to set up, does not require venpuncture, but is associated with high bioavailability of the administered drug. Information on the pharmacokinetics of dexmedetomidine in the pediatric population is very limited, especially in children. To the best of investigators knowledge, there are no published reports on the pharmacokinetics of nebulized dexmedetomidine in children.

Official Title
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Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine in Preschool Children Undergoing Abdominal Cancer Surgery

Conditions
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Abdominal Cancer

Intervention / Treatment
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* Drug: nebulized Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: child aged 2-7 years ASA I or II scheduled for abdominal surgery with average weight, height, normal serum albumin Exclusion Criteria: patients with allergy to the study drug patients with significant organ dysfunction patients with cardiac arrhythmia patients with congenital heart disease use of psychotropic medication and mental retardation.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nebulized dexmedetomidine 2ug/kg<br>inhalation of dexmedetomidine in the dose of 2ug/kg by nebulization | Drug: nebulized Dexmedetomidine<br>* inhalation of dexmedetomidine by nebulizer. the study drug will be prepared in 3 ml of 0.9% saline and will be administered by standard hospital jet nebulizer via face-mask with continuous flow of 100%oxygen at 6 l/m for 10 to 15 min<br>* Other names: pharmacokinitics of nebulized dexmedetomidine;|
| Active Comparator: nebulized dexmedetomidine 3ug/kg<br>inhalation of dexmedetomidine in the dose of 3ug/kg by nebulization | Drug: nebulized Dexmedetomidine<br>* inhalation of dexmedetomidine by nebulizer. the study drug will be prepared in 3 ml of 0.9% saline and will be administered by standard hospital jet nebulizer via face-mask with continuous flow of 100%oxygen at 6 l/m for 10 to 15 min<br>* Other names: pharmacokinitics of nebulized dexmedetomidine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinitics of dexmedetomidine | serum level of dexmedetomidine | at the basline and after the end of nebuization of the drug at 5 minutes,15 minutes,30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sedation score | Ramsy sedation score 1 = Anxious or restless or both Unacceptable; increase sedation 2=Cooperative, orientated and tranquil Acceptable; no action necessary 3=Responding to commands Acceptable; no action necessary 4=Brisk response to stimulus Acceptable; no action necessary 5=Sluggish response to stimulus Unacceptable; monitor respiratory status and sedation level until stable at 2 or 3 6= No response to stimulus Unacceptable; monitor respiratory status and sedation level until stable at 2 or 3 | baseline and after end of the drug adminstration by 30 mininute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinitics, nebulized, dexmedetomidine, preschool children