Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine

Phase 1

• Conditions: Abdominal Cancer
• Interventions: Drug: nebulized Dexmedetomidine

• Registration Number: NCT03762785
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Study Start: 2018-12-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-10
• Primary Completion: 2020-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nebulized dexmedetomidine 3ug/kg	nebulized Dexmedetomidine	inhalation of dexmedetomidine in the dose of 3ug/kg by nebulization
nebulized dexmedetomidine 2ug/kg	nebulized Dexmedetomidine	inhalation of dexmedetomidine in the dose of 2ug/kg by nebulization

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

South Egypt Cancer Institute; 🇪🇬 Assiut, Egypt