Phase 1
Completed N=30
Understanding Dexmedetomidine in Neonates After Open Heart Surgery
Tetrology of Fallot · Heart Ventricle · Hypoplastic Left Heart
Source: ClinicalTrials.gov NCT00576381 ↗
Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Apr 2013
Primary outcomePrimary: PK Profile of Dexmedetomidine — 110 mL/min
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PK Profile of Dexmedetomidine |
110 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00576381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.