Understanding Dexmedetomidine in Neonates After Open Heart Surgery

Athena Zuppa

Status and phase: Completed; Phase 1

Conditions: Heart Ventricle; Tetrology of Fallot; Hypoplastic Left Heart

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT00576381

CTRC 2006

2006-4-4757

Details and patient eligibility

About

The purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery. We want to learn how long the drug stays in the body, how the drug is metabolized by the body, and how well the medicine works at a particular dose or amount.

Full description

This is a single center, dose escalation study of a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours in neonates who are immediately post-op from cardiac surgery, and require tracheal intubation with mechanical ventilation in the post-op period.

Pediatric populations may benefit from the favorable pharmacodynamic effects of this medication.

Enrollment: 30 patients

Sex: All

Ages: 1 hour to 30 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be less than or equal to 1 month old.
• Postconceptual age must be > or equal to 37 weeks on the day of surgery.
• Postoperative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period.
• Planned tracheal extubation within 24 hrs post-op.
• Adequate renal function (serum creatine < or equal to 1.5mg/dL)
• Adequate liver function (ALT < or equal to 165 U/L)
• Isolated heart surgery
• Informed consent

Exclusion criteria

• Patients who have received another investigational drug since birth.
• Patients receiving continuous infusions of muscle relaxants in the post-op setting.
• Pateints who have a positive blood culture without a subsequent negative culture of other evidence of ongoing serious infection.
• Patients who show signs and symptoms of elevated intracranial pressure.
• Post-op hypotension defined by post conceptual age.
• Pre-existing bradycardia defined by age
• Heart block
• Weight < 2kg
• Patients who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

A

Experimental group

Description:

Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery.

Treatment:

Drug: Dexmedetomidine