Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine

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

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

Study Overview

• Status: Unknown
• Conditions: Abdominal Cancer
• Intervention / Treatment: Drug: nebulized Dexmedetomidine

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 Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 11715
    • Recruiting
    • South Egypt Cancer Institute
    • Contact: Hala S Abdelgafar, Professor; Phone Number: 01003812011; Email: hallasaad@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: nebulized dexmedetomidine 2ug/kg; inhalation of dexmedetomidine in the dose of 2ug/kg by nebulization	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; Other Names: pharmacokinitics of nebulized dexmedetomidine
ACTIVE_COMPARATOR: nebulized dexmedetomidine 3ug/kg; inhalation of dexmedetomidine in the dose of 3ug/kg by nebulization	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; Other Names: pharmacokinitics of nebulized dexmedetomidine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Shereen M Kamal, Lecturer, Ministry of higher education

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2018
• Primary Completion (ANTICIPATED): January 1, 2020
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (ACTUAL): December 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 9, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: dexmedetomidine; preschool children; nebulized; pharmacokinitics
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Abdominal Neoplasms; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 435

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No