Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine

Assiut University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Abdominal Cancer

Treatments: Drug: nebulized Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03762785

435

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups

nebulized dexmedetomidine 2ug/kg

Active Comparator group

Description:

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

Treatment:

Drug: nebulized Dexmedetomidine

nebulized dexmedetomidine 3ug/kg

Active Comparator group

Description:

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

Treatment:

Drug: nebulized Dexmedetomidine