Use of Dexmedetomidine in Children Undergoing Cardiac Surgery

Study Overview
=================
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.

Official Title
-----------------
Use of Dexmedetomidine in Children Undergoing Cardiac Surgery

Conditions
-----------------
Deep Sedation

Intervention / Treatment
-----------------
* Drug: dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
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 -

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cases<br>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. | Drug: dexmedetomidine<br>* dexmedetomidine continous infusion 0.5 mcg/kg/h<br>* Other names: dexdor;|
| No Intervention: controls<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mechanical ventilation time | 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 | participants will be followed for the duration of ICU stay, an expected average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgo-sedation level | 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. | participants will be followed for the duration of ICU stay, an expected average of 5 days | 
| withdrawal symptoms | 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 | participants will be followed for the duration of ICU stay, an expected average of 5 days | 
| safety of dexmedetomidine infusion as a measure of systemic pressure decrease | 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 | participants will be followed for the duration of ICU stay, an expected average of 5 days |