Sedation With Dexmedetomidine During Cardiac Catheterization

Summary

Clinical dose escalation drug trial to evaluate the effect of 3 different doses of dexmedetomidine on the pulmonary vascular bed in pediatric subjects with elevated pulmonary vascular resistance (PVR). The study will be conducted in 2 parts, with part 1 incorporating stopping rules to optimize safety of the drug in this population. The second part of this study will evaluate if the lowest safest dose, as determined in part 1, is adequate to provide effective sedation during a cardiac catheterization procedure.

Timeline

Start

2010-03

Primary completion

2013-03

Completion

2013-04

Outcome

Outcome not reported

Stopped: “Study was terminated due to increased PVR in one subject from T0-T1 reaching the level of a predetermined stopping rule”

Drugs

Indications