Phase 3
N=41
The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease
Cardiac Transplant · Patent Ductus Arterious · Atrial Septal Defect · Bidirectional Cavopulmonary Anastomosis
Bottom Line
View on ClinicalTrials.gov: NCT00480740 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine. — -0.14; -0.16; -0.21; 0.15 percentage of change from baseline — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexmedetomidine (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's National Research Institute
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine. |
-0.14; -0.16; -0.21; 0.15; 0.18; 0.22 | 0.05 |
Summary
The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who have had a cardiac transplant, and patients with otherwise normal physiology who are undergoing closure of a patent ductus arteriosis or atrial septal defect.
Eligibility Criteria
Inclusion Criteria
- age is birth to 18 years
- > or = 6 kg.
- American Society of Anesthesiology (ASA) I, II, or III
- undergone prior cardiac transplant, Fontan or has a patent ductus arterious or atrial septal defect.
- scheduled for cardiac catheterization
Exclusion Criteria
- subject or family history of malignant hyperthermia
- known hepatic disorder determined by history physical exam or laboratory tests
- pregnant or lactating female
- receiving inotropic agents or has a pacemaker
- weighs less than 6 kg.
Data sourced from ClinicalTrials.gov (NCT00480740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.