Deep SedationPhase 2NCT02375243
Use of Dexmedetomidine in Children Undergoing Cardiac Surgery
A Phase 2 study testing dexmedetomidine in people with Deep Sedation, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Deep Sedation
- What is being tested?
- dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2014to Jan 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 2 years
- All sexes
- No healthy volunteers
- Child
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
-
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Deep Sedation
- Being tested
- dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
Also called dexdor
dexmedetomidine continous infusion 0.5 mcg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| cases | Experimental | 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. Receives: Drug: dexmedetomidine |
| controls | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: participants will be followed for the duration of ICU stay, an expected average of 5 days
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: participants will be followed for the duration of ICU stay, an expected average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startFeb 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiana Garisto, Bambino Gesù Hospital and Research Institute
- Investigators
- Paola Cogo, doctor, Study chair, Bambino Gesù Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375243
- Sponsor's protocol ID
- 942LB
- Status last verified
- Feb 2017
- First submitted
- 25 Oct 2014
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Dexmedetomidine in Children Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02375243
- Acronym / sponsor ID
- 942LB
- Conditions
- Deep Sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | Experimental | Drug: dexmedetomidinechildren 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. |
| controls | No intervention | –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. |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmedetomidineAlso: dexdordexmedetomidine continous infusion 0.5 mcg/kg/h | Drug | cases |
Primary outcome
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
3 secondary outcomes
analgo-sedation level
Time frame: participants will be followed for the duration of ICU stay, an expected average of 5 days
withdrawal symptoms
Time frame: 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
Time frame: participants will be followed for the duration of ICU stay, an expected average of 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola Cogo, doctor study chair
Bambino Gesù Children Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dexmedetomidine in people with Deep Sedation, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mechanical ventilation time (time frame: participants will be followed for the duration of ICU stay, an expected average of 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.