CompletedPhase 1

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

United States119 participantsStarted 2014-04-02

Plain-language summary

The purpose of this Phase I study is to determine the safety of a drug called dexmedetomidine (DEX) as part of a balanced general anesthetic and sedative strategy for neonates and infants undergoing corrective cardiac surgery that requires the use of cardiopulmonary bypass for congenital cardiac problems. This study will also design and validate a dosing schema for the use of DEX as described above.

Who can participate

Age range180 Days

SexALL

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Inclusion criteria

✓. Male or female, age 0 to 180 days at the time of surgery.
✓. Diagnosis of: 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)
✓. Scheduled for complete corrective two-ventricle surgical repair with cardiopulmonary bypass.

What they're measuring

The occurrence of a safety event that is possibly, probably or definitely related to DEX administration

Timeframe: Within 4 hours after DEX adminstration

Trial details

NCT IDNCT01915277

SponsorCarelon Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10-16

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