Use of Dexmedetomidine in Children Undergoing Cardiac Surgery

Phase 2

Completed

• Conditions: Deep Sedation
• Interventions: Drug: dexmedetomidine

• Registration Number: NCT02375243
• Lead Sponsor: Bambino Gesù Hospital and Research Institute

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-10-25
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-02
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-11
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cases	dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bambino Gesù Children's Hospital; 🇮🇹 Rome, Italy