Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine
1 other identifier
interventional
16
1 country
1
Brief Summary
the aim of this study is to study the pharmacokinetics and dynamics of nebulized dexmetedomidine in children undergoing major abdominal cancer surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2018
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2018
CompletedFirst Posted
Study publicly available on registry
December 4, 2018
CompletedStudy Start
First participant enrolled
December 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedJanuary 10, 2019
January 1, 2019
1.1 years
November 29, 2018
January 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
sedation score
baseline and after end of the drug adminstration by 30 mininute
Study Arms (2)
nebulized dexmedetomidine 2ug/kg
ACTIVE COMPARATORinhalation of dexmedetomidine in the dose of 2ug/kg by nebulization
nebulized dexmedetomidine 3ug/kg
ACTIVE COMPARATORinhalation of dexmedetomidine in the dose of 3ug/kg by nebulization
Interventions
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
Eligibility Criteria
You may qualify if:
- child aged 2-7 years
- ASA I or II
- scheduled for abdominal surgery
- with average weight, height, normal serum albumin
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Egypt Cancer Institute
Asyut, 11715, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Shereen M Kamal, Lecturer
Ministry of higher education
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of anesthesia, ICU and pain manegement
Study Record Dates
First Submitted
November 29, 2018
First Posted
December 4, 2018
Study Start
December 10, 2018
Primary Completion
January 1, 2020
Study Completion
January 1, 2021
Last Updated
January 10, 2019
Record last verified: 2019-01