Abdominal Cancer
Conditions
Keywords
pharmacokinitics, nebulized, dexmedetomidine, preschool children
Brief summary
the aim of this study is to study the pharmacokinetics and dynamics of nebulized dexmetedomidine in children undergoing major abdominal cancer surgery.
Detailed description
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.
Interventions
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
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pharmacokinitics 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 | serum level of dexmedetomidine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sedation score | baseline and after end of the drug adminstration by 30 mininute | 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 |
Countries
Egypt
Contacts
Primary ContactShereen M Kamal, Lecturer
Backup ContactHala S Abdelgafar, Profesor
Outcome results
None listed