At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 13 enrolled
Drug / intervention
Dexmedetomidine Hydrochloridedrug
Likely dose
Dexmedetomidine Hydrochloride 0.5mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetic-pharmacodynamic Analysis for Dosing Strategy and Evaluation of Safety and Efficacy of Dexmedetomidine in Children
In Brief
A Phase 2 clinical trial evaluating Dexmedetomidine Hydrochloride for Intensive Care Unit and Postoperative Care. Completed, enrolled 13 participants across 1 site.
Detailed Summary
This study evaluates pharmacokinetics and pharmacodynamics of dexmedetomidine for children under sedation at intensive care unit after surgery. Patients will receive dexmedetomidine intravenously for 50 minutes after surgery as as sedation drug.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntensive Care Unit, Postoperative Care
CountriesSouth Korea
CollaboratorsMinistry of Food and Drug Safety, Korea
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 2019
Enrollment StartAug 2019
Primary CompletionNov 2019
TodayJul 2026
First PostedJul 22, 2019
Enrollment StartAug 14, 2019
Primary CompletionNov 14, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.9 years ago
Interventions
Dexmedetomidine Hydrochloridedrug
Intravenous infusion of dexmedetomidine at the rate of 0.5mcg/kg for 10 min, then 0.5mcg/kg/hr for 50 min.