NCT02375243

Use of Dexmedetomidine in Children Undergoing Cardiac Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Bambino Gesù Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 1 Month – 2 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the efficacy of dexmedetomidine in reducing the need for sedatives and analgesics in the immediate post-operative period in children who underwent surgical correction of complex congenital heart disease

Detailed description

The hypothesis the investigators want to verify is that the reduced administration of sedative drugs (opioids and benzodiazepines) in children undergoing cardiac surgery, reduces the side effects of the drugs themselves, such as respiratory depression (reduction of mechanical ventilation) and the onset of withdrawal symptoms while maintaining an adequate analgo-sedation. The study is an unblinded randomized controlled study. It will involve 60 children aged \> 1 and \< 24 months sedated and mechanically ventilated after corrective or palliative surgery of congenital heart disease on cardiopulmonary bypass with Aristotle score \> 8. Dexmedetomidine infusion will be started upon arrival in the CICU and continued until the time of discontinuation of morphine.

Conditions

• Deep Sedation

Interventions

Type	Name	Description
DRUG	dexmedetomidine	dexmedetomidine continous infusion 0.5 mcg/kg/h

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2015-03-02
• Last updated: 2017-02-14

Locations

1 site across 1 country: Italy