Dexmedetomidine (Dosing Study)

A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics

The purpose of this study is to figure out safe doses of a medicine called dexmedetomidine for babies having heart surgery. We also want to learn how long the medicine stays in the body, and how infants’ bodies absorb and get rid of this medicine (This is called pharmacokinetics). This is an important step in learning what the best dose of dexmedetomidine should be for infants. The study was done at three Pediatric Heart Network centers. 119 patients across the centers were enrolled in this study.

Who was in the study?

This is study was for males or females 180 days old, who had a diagnosis of different types of cardiac anomalies such as D-transposition of the great arteries (with or without ventricular septal defect), or tetralogy of Fallot, or ventricular septal defect (with or without associated atrial septal defect and/or patent ductus arteriosus, and were scheduled for surgery for a heart condition.

What happened in the study?

The study was done in two parts. In the first part of this study, groups of children received carefully determined, increasing doses of dexmedetomidine, starting in the operating room and continuing after surgery in the intensive care unit (ICU). Based on what we learned from these groups, a dosing schedule was developed for low, medium, and high doses, using a computer program that took into account a child’s age, weight, time of surgery, and other information. In the second part of this study, children got the dexmedetomidine doses that had been carefully developed and reviewed by doctors during the first part of the study, to make sure that the dosing schedule was proper.

What were the results of the study?

Results of this study are currently being analyzed. The PHN is grateful to all of the families who participated in this study.