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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nebulized dexmedetomidine 2ug/kg | Active Comparator | inhalation of dexmedetomidine in the dose of 2ug/kg by nebulization |
|
| nebulized dexmedetomidine 3ug/kg | Active Comparator | inhalation of dexmedetomidine in the dose of 3ug/kg by nebulization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nebulized Dexmedetomidine | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shereen M Kamal, Lecturer | Contact | +201006279209 | sheridouh79@yahoo.com | |
| Hala S Abdelgafar, Profesor | Contact | +201003812011 | hallasaad@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Shereen M Kamal, Lecturer | Ministry of higher education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Egypt Cancer Institute | Recruiting | Asyut | 11715 | Egypt |
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| baseline and after end of the drug adminstration by 30 mininute |