ACTRN12615001304527
Completed
Phase 2
In children requiring surgical repair of congenital cardiac defects, does the use of Dexmedetomidine as the primary sedative agent compared to Midazolam reduce the length of mechanical ventilation and PICU length of stay.
Paediatic Critical Care Research Group0 sites66 target enrollmentNovember 30, 2015
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Paediatic Critical Care Research Group
- Enrollment
- 66
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The patient is undergoing surgical repair of a congenital heart defect requiring cardiopulmonary bypass and will require mechanical ventilation via an endotracheal tube post\-operatively, and the treating clinician believes that:
- •2\.The patient will require immediate post\-operative AND ongoing sedative medication for comfort, safety, and to facilitate the delivery of life support measures.
- •3\.The patient is expected to remain intubated post\-operatively.
Exclusion Criteria
- •1\. Age \> 12 months
- •2\. Proven or suspected acute primary brain lesion that may result in global impairment of conscious level or cognition, such as traumatic brain injury, intracranial haemorrhage, intracranial infection or hypoxic brain injury.
- •3\. Allergy to dexmedetomidine
Outcomes
Primary Outcomes
Not specified
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