Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine

Overview

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

Full Title of Study: “Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine in Preschool Children Undergoing Abdominal Cancer Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: January 2020

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

  • Drug: nebulized Dexmedetomidine
    • 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

Arms, Groups and Cohorts

  • Active Comparator: nebulized dexmedetomidine 2ug/kg
    • inhalation of dexmedetomidine in the dose of 2ug/kg by nebulization
  • Active Comparator: nebulized dexmedetomidine 3ug/kg
    • inhalation of dexmedetomidine in the dose of 3ug/kg by nebulization

Clinical Trial Outcome Measures

Primary Measures

  • pharmacokinitics of dexmedetomidine
    • Time Frame: 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 Measures

  • sedation score
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 7 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shereen Mamdouh, lecturer of anesthesia, ICU and pain manegement – Assiut University
  • Overall Official(s)
    • Shereen M Kamal, Lecturer, Principal Investigator, Ministry of higher education
  • Overall Contact(s)
    • Shereen M Kamal, Lecturer, +201006279209, sheridouh79@yahoo.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.