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NCT Number: NCT02375243

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

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Key information

Conditions

Deep Sedation

Age range

1 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bambino Gesù Children's Hospital

Rome, 00100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Dexmedetomidine

Drug

dexmedetomidine continous infusion 0.5 mcg/kg/h

Other names: dexdor

Primary outcomes

  1. mechanical ventilation time

    Time frame: 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 outcomes

  1. analgo-sedation level

    Time frame: 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.

  2. withdrawal symptoms

    Time frame: 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

  3. safety of dexmedetomidine infusion as a measure of systemic pressure decrease

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bambino Gesù Hospital and Research Institute

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 2, 2015
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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