NCT01915277

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Carelon Research · Academic / Other
• Sex: All
• Age: 180 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Transposition of the Great Arteries
• Tetralogy of Fallot
• Ventricular Septal Defect

Interventions

Type	Name	Description
DRUG	Dexmedetomidine

Timeline

• Start date: 2014-04-02
• Primary completion: 2017-10-16
• Completion: 2017-10-17
• First posted: 2013-08-02
• Last updated: 2018-03-23

Locations

4 sites across 1 country: United States