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Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine

Primary Purpose

Abdominal Cancer

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
nebulized Dexmedetomidine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdominal Cancer focused on measuring pharmacokinitics, nebulized, dexmedetomidine, preschool children

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • South Egypt Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

nebulized dexmedetomidine 2ug/kg

nebulized dexmedetomidine 3ug/kg

Arm Description

inhalation of dexmedetomidine in the dose of 2ug/kg by nebulization

inhalation of dexmedetomidine in the dose of 3ug/kg by nebulization

Outcomes

Primary Outcome Measures

pharmacokinitics of dexmedetomidine
serum level of dexmedetomidine

Secondary Outcome Measures

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

Full Information

First Posted
November 29, 2018
Last Updated
January 9, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03762785
Brief Title
Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine
Official Title
Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine in Preschool Children Undergoing Abdominal Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Cancer
Keywords
pharmacokinitics, nebulized, dexmedetomidine, preschool children

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nebulized dexmedetomidine 2ug/kg
Arm Type
Active Comparator
Arm Description
inhalation of dexmedetomidine in the dose of 2ug/kg by nebulization
Arm Title
nebulized dexmedetomidine 3ug/kg
Arm Type
Active Comparator
Arm Description
inhalation of dexmedetomidine in the dose of 3ug/kg by nebulization
Intervention Type
Drug
Intervention Name(s)
nebulized Dexmedetomidine
Other Intervention Name(s)
pharmacokinitics of nebulized dexmedetomidine
Intervention Description
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
Primary Outcome Measure Information:
Title
pharmacokinitics of dexmedetomidine
Description
serum level 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
Secondary Outcome Measure Information:
Title
sedation score
Description
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
Time Frame
baseline and after end of the drug adminstration by 30 mininute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shereen M Kamal, Lecturer
Phone
+201006279209
Email
sheridouh79@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hala S Abdelgafar, Profesor
Phone
+201003812011
Email
hallasaad@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shereen M Kamal, Lecturer
Organizational Affiliation
Ministry of higher education
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Egypt Cancer Institute
City
Assiut
ZIP/Postal Code
11715
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shereen M Kamal, Lecturer
Phone
01006279209
Email
sheridouh79@yahoo.com
First Name & Middle Initial & Last Name & Degree
Hala S Abdelgafar, Professor
Phone
01003812011
Email
hallasaad@yahoo.com

12. IPD Sharing Statement

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Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine

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