Use of Dexmedetomidine in Children Undergoing Cardiac Surgery

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

Study Overview

• Status: Completed
• Conditions: Deep Sedation
• Intervention / Treatment: Drug: dexmedetomidine

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00100
    • Bambino Gesu Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: dexmedetomidine; dexmedetomidine continous infusion 0.5 mcg/kg/h; Other Names: dexdor
No Intervention: 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.

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

Collaborators and Investigators

• Sponsor: Bambino Gesù Hospital and Research Institute
• Investigators: Study Chair: Paola Cogo, doctor, Bambino Gesu Children Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: October 25, 2014
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): March 2, 2015

Study Record Updates

• Last Update Posted (Actual): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 11, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 942LB