Use of Dexmedetomidine in Children Undergoing Cardiac Surgery
NCT ID: NCT02375243
Last Updated: 2017-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2014-02-28
2016-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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cases
children who receive midazolam 0.05 mg/kg/h + morphine 10 mcg/kg/h + dexmedetomidne 0.5 mcg/kg/h. Midazolam in administered until extubation, while morphine and dexmedetomidine are administered until removal of surgical drains.
dexmedetomidine
dexmedetomidine continous infusion 0.5 mcg/kg/h
controls
standard care: children who receive midazolam 0.1 mg/kg/h + morphine 20 mcg/kg/h. Midazolam in administered until extubation, while morphine is administered until removal of surgical drains.
No interventions assigned to this group
Interventions
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dexmedetomidine
dexmedetomidine continous infusion 0.5 mcg/kg/h
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
1 Month
2 Years
ALL
No
Sponsors
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Bambino Gesù Hospital and Research Institute
OTHER
Responsible Party
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Cristiana Garisto
physician
Principal Investigators
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Paola Cogo, doctor
Role: STUDY_CHAIR
Bambino Gesù Children Hospital
Locations
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Bambino Gesù Children's Hospital
Rome, Rome, Italy
Countries
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Other Identifiers
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942LB
Identifier Type: -
Identifier Source: org_study_id
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