Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine

Abdominal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03762785
• Other study ID #: 435
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 10, 2018
• Est. completion date: January 2021

Study information

• Verified date: January 2019
• Source: Assiut University
• Contact: Shereen M Kamal, Lecturer
• Phone: +201006279209
• Email: sheridouh79[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: January 2021
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Cancer
• Abdominal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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