Use of Dexmedetomidine in Children Undergoing Cardiac Surgery

Deep Sedation Clinical Trial

Official title:

Use of Dexmedetomidine in Children Undergoing Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375243
• Other study ID #: 942LB
• Status: Completed
• Phase: Phase 2
• First received: October 25, 2014
• Last updated: February 11, 2017
• Start date: February 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2017
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Sedation

Intervention

Drug:
• dexmedetomidine
dexmedetomidine continous infusion 0.5 mcg/kg/h

Locations

Country	Name	City	State
Italy	Bambino Gesù Children's Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Bambino Gesù Hospital and Research Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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