Respiratory MorbidityNCT02555605
Dexmedetomidine Sedation in Children With Respiratory Morbidities
An observational study of Respiratory Morbidity, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
This study aimed to determine the feasibility of dexmedetomidine in children with respiratory morbidities who required deep sedation for magnetic resonance imaging (MRI) scans. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Respiratory Morbidity
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2013to Jul 2015
- Phase
- Observational
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children up to the age of 16 years with at least 3 characteristics of respiratory morbidities were identified as having increased risk for adverse respiratory events and they were eligible for participation in this evaluation.
Who may be able to join
- Children up to the age of 16 years with at least 3 characteristics of respiratory morbidities
Who cannot join
- Children who had an American Society of Anaesthesiologists (ASA) physical status classification IV
- Documented pre-existing cardiac conduction abnormalities
- Renal impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Dexmedetomidine in Children With Respiratory Morbidities Undergoing Deep Sedation for Magnetic Resonance Imaging
This study aimed to determine the feasibility of dexmedetomidine in children with respiratory morbidities who required deep sedation for magnetic resonance imaging (MRI) scans.
Read the detailed description
Electronic medical records of children with at least 3 characteristics of respiratory morbidities were retrospectively reviewed. All study patients received dexmedetomidine bolus over 10 min followed by a continuous infusion to achieve a minimum Ramsay Sedation Score of 5. Patients were monitored for hemodynamics, total dose of dexmedetomidine received, adverse events experienced and sedation characteristics.
- Conditions
- Respiratory Morbidity
- Being tested
- Dexmedetomidine
- Keywords
- children, dexmedetomidine, magnetic resonance imaging scans, deep sedation, adverse respiratory events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexdor
Children up to the age of 16 years requiring MRI under deep sedation with at least 3 characteristics of respiratory morbidities were identified as having increased risk for adverse respiratory events. Dexmedetomidine was administered as a first bolus of 1 mcg•kg-1 over 10 min, followed by a continuous infusion at 1.0 mcg•kg-1•h-1. Sedation level was assessed by Ramsay Sedation Scale and it was initially recorded at 1-min interval. If the child failed to achieve a minimum RSS of 5, this bolus was repeated once again and the continuous infusion was subsequently increased to 2 mcg•kg-1•h-1. In addition, propofol 0.5 mg.kg-1 iv. was allowed to be administered, in patients still exhibiting movement that could interfere with image acquisition.
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of successful sedation
completion of imaging without requirement for rescheduling or general anaesthesia, and in the absence of adverse respiratory events such as apnoea, cough, oxygen desaturation, and bronchospasm or unplanned escalation of care (e.g. transfer from ward to paediatric intensive care unit or prolonged hospitalization).
Measured: 1 hour
Secondary outcomes (3)
the presence of bradycardia
Based on age-adjusted criteria, bradycardia was defined as a HR <20% below the lower limit of the normal ranges expressed in beats/min
Measured: 4 hours
the presence of hypertension
Based on age-adjusted criteria hypertension was defined as a MAP >20% above the upper limit of the normal ranges expressed in mmHg
Measured: 4 hours
the presence of nausea and vomiting.
defined as the occurrence of nausea and vomitting, expressed in "yes" or "no"
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startNov 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory MorbidityStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
- Investigators
- Nadia Najafi, MD, Principal investigator, Universitair Ziekenhuis BrusselJan Poelaert, PhD MD, Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555605
- Sponsor's protocol ID
- DEXMRI20
- Status last verified
- Sep 2015
- First submitted
- 11 Aug 2015
- Last updated
- 21 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Najafi N, Veyckemans F, Van de Velde A, Poelaert J. Usability of dexmedetomidine for deep sedation in infants and small children with respiratory morbidities. Acta Anaesthesiol Scand. 2016 Aug;60(7):865-73. doi: 10.1111/aas.12715. Epub 2016 Mar 4.
PubMed 26940080
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Dexmedetomidine in Children With Respiratory Morbidities Undergoing Deep Sedation for Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02555605
- Acronym / sponsor ID
- DEXMRI20
- Conditions
- Respiratory Morbidity
- Keywords
- children, dexmedetomidine, magnetic resonance imaging scans, deep sedation, adverse respiratory events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 21 Sep 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.
This study aimed to determine the feasibility of dexmedetomidine in children with respiratory morbidities who required deep sedation for magnetic resonance imaging (MRI) scans.
Detailed description
Electronic medical records of children with at least 3 characteristics of respiratory morbidities were retrospectively reviewed. All study patients received dexmedetomidine bolus over 10 min followed by a continuous infusion to achieve a minimum Ramsay Sedation Score of 5. Patients were monitored for hemodynamics, total dose of dexmedetomidine received, adverse events experienced and sedation characteristics.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children up to the age of 16 years with at least 3 characteristics of respiratory morbidities were identified as having increased risk for adverse respiratory events and they were eligible for participation in this evaluation.
Key inclusion criteria (1 listed)
- Children up to the age of 16 years with at least 3 characteristics of respiratory morbidities
Key exclusion criteria (3 listed)
- Children who had an American Society of Anaesthesiologists (ASA) physical status classification IV
- Documented pre-existing cardiac conduction abnormalities
- Renal impairment
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: DexdorChildren up to the age of 16 years requiring MRI under deep sedation with at least 3 characteristics of respiratory morbidities were identified as having increased risk for adverse respiratory events. Dexmedetomidine was administered as a first bolus of 1 mcg•kg-1 over 10 min, followed by a continuous infusion at 1.0 mcg•kg-1•h-1. Sedation level was assessed by Ramsay Sedation Scale and it was initially recorded at 1-min interval. If the child failed to achieve a minimum RSS of 5, this bolus was repeated once again and the continuous infusion was subsequently increased to 2 mcg•kg-1•h-1. In addition, propofol 0.5 mg.kg-1 iv. was allowed to be administered, in patients still exhibiting movement that could interfere with image acquisition. | Drug | – |
Primary outcome
the occurrence of successful sedation
Time frame: 1 hour
completion of imaging without requirement for rescheduling or general anaesthesia, and in the absence of adverse respiratory events such as apnoea, cough, oxygen desaturation, and bronchospasm or unplanned escalation of care (e.g. transfer from ward to paediatric intensive care unit or prolonged hospitalization).
3 secondary outcomes
the presence of bradycardia
Time frame: 4 hours
the presence of hypertension
Time frame: 4 hours
the presence of nausea and vomiting.
Time frame: 4 hours
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 21 Sep 2015.
- Derived from this study: PubMed 26940080Najafi N, Veyckemans F, Van de Velde A, Poelaert J. Usability of dexmedetomidine for deep sedation in infants and small children with respiratory morbidities. Acta Anaesthesiol Scand. 2016 Aug;60(7):865-73. doi: 10.1111/aas.12715. Epub 2016 Mar 4.
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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.
Nadia Najafi, MD principal investigator
Universitair Ziekenhuis Brussel
Jan Poelaert, PhD MD study chair
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Morbidity, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. 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 21 Sep 2015. 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 Belgium. 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.
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?
the occurrence of successful sedation (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02555605, which also lists 1 linked publication.
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 21 Sep 2015.