Deep Sedation
Conditions
Brief 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.
Interventions
DRUGdexmedetomidine
dexmedetomidine continous infusion 0.5 mcg/kg/h
Sponsors
Bambino Gesù Hospital and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 2 Years
Healthy volunteers
No
Inclusion criteria
age \< 24 months but \> 30 days, Aristotle score \>8, elective procedures in cardiopulmonary bypass -
Exclusion criteria
atrioventricular block prior to the start of infusion; vasoactive inotropic score on arrival to the CICU\>30; brain malformations orbone, muscle or neuromuscolar disease; pleural effusion or pneumothorax prior to the study; hepatic or renal failure \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mechanical ventilation time | participants will be followed for the duration of ICU stay, an expected average of 5 days | To evaluate the efficacy of dexmedetomidine, administered in combination with midazolam and morphine, in reducing the time of mechanical ventilation, due to lower consumption of opioids and hypnotics and subsequent reduction of respiratory depression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| analgo-sedation level | participants will be followed for the duration of ICU stay, an expected average of 5 days | efficient analgo-sedation guaranteed by the effectiveness of opioids and benzodiazepines with dexmedetomidine by using the Comfort scale and measuring the total amount of opioids and benzodiazepines received in the two groups. |
| withdrawal symptoms | participants will be followed for the duration of ICU stay, an expected average of 5 days | onset of withdrawal symptoms due to abstinence from opioids and benzodiazepines evaluated using Sophia Observation withdrawal Symptoms scale in patients who received a continuous infusion for at least 72 hours |
| safety of dexmedetomidine infusion as a measure of systemic pressure decrease | participants will be followed for the duration of ICU stay, an expected average of 5 days | assessment of the safety of dexmedetomidine infusion in light of hemodynamic changes induced by the drug (hypotension will be considered a reduction of \> 20% of the mean arterial pressure, bradycardia a reduction in heart rate \>20% of baseline |
Countries
Italy
Outcome results
None listed