(Dosing Study)

Study Summary

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

The purpose of this study was to figure out safe doses of a medicine called dexmedetomidine for babies having heart surgery. We also wanted 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.

119 Patients

Were enrolled in this study.

3 Centers

Three Pediatric Heart Network centers participated.

2 Part Study

This study was conducted in two parts.

Who was in the study?

This study enrolled infants up to 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 during 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?

Use of dexmedetomidine resulted in low incidence and severity of adverse safety events in infants undergoing cardiac surgery with CPB. This study should assist clinicians in selecting an appropriate dose. The results of this phase 1 safely trial provide preliminary data for a larger phase 3 trial of dexmedetomidine. The PHN is grateful to all of the families who participated in this study.

Study Publications

  • Results of a phase 1 multicentre investigation of dexmedetomidine bolus and infusion in corrective infant cardiac surgery

    A. F. Zuppa, Br J Anaesth. 2019 Dec;123(6):839-852.

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