MRI SedationPhase 4DexmedMRINCT03806777
Intra-nasal Dexmedetomidine for Children Undergoing MRI Imaging
A Phase 4 study testing Dexmedetomidine in people with MRI Sedation, run by University of British Columbia.
Trial summary
This study aims to assess the use of intranasal dexmedetomidine (IN-dex) as a sole agent in aiding the successful completion of a MRI scans in children. Dexmedetomidine, a routinely used anesthetic agent in our institution, has many benefits including sedation with neuro-protective and respiratory sparing features. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- MRI Sedation
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to Oct 2020
- Phase
- Phase 4
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ASA 1 or 2
- Scheduled for elective MRI scan on the general anesthesia list
- Child Life MRI simulation score of 6-10 (Figure 1)
- Age 3 - 18
Who cannot join
- Taking existing opioid, sedative, or cannabinoid medication
- Severe learning disability defined as the inability to follow simple commands
- Severe Cardiac disease
- Chronic hypertension
- Allergy to dexmedetomidine
- Nasal anatomical abnormality
- Known or anticipated difficult airway
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to assess the use of intranasal dexmedetomidine (IN-dex) as a sole agent in aiding the successful completion of a MRI scans in children. Dexmedetomidine, a routinely used anesthetic agent in our institution, has many benefits including sedation with neuro-protective and respiratory sparing features. We will test its effectiveness in completing MRI scans in children that would otherwise be given a full general anesthetic.
Read the detailed description
Purpose:
To assess the use of IN-dex as a sole agent in aiding the successful completion of a MRI scan in children.
Hypothesis:
We hypothesize that the optimal dose for IN-dex to produce appropriate sedation for MRI will be between 1 and 3 mcg/kg. We also hypothesize that this dose will be lower in the older age group.
Justification:
The dose required for IN-dex to enable safe sedation for MRI scanning as a sole agent is undetermined at present. This study will enable us to find the optimal dose for effective sedation for MRI scanning in a range of age groups. This will avoid the need for propofol and remifentanil general anesthesia (that is the current standard of care) in this group of patients. Our motivation for avoiding general anesthesia is that there is ongoing concern that general anesthesia causes long term neurocognitive effects in children. Finally, identifying a safe yet effective dose of IN-dex, which can be nurse-administered, will also allow us to improve access to MRI scans that are limited by the access to general anesthesia.
Objectives:
- To determine the dose of IN-dex that, when used as a sole agent, produces minimal to moderate sedation that is adequate for successful completion of MRI in children with >90% effectiveness.
- To explore the logistics of a nurse-administered sedation protocol to increase access to the MRI.
Research Design:
We propose a dose finding study of IN-dex using the biased coin design (BCD) method in three different age groups (3 to <8 years, 8 to <12 years, 12 to <19 years). The study specific interventions will include identification of children appropriate for the study following detailed assessment using a scoring system developed by our Child Life specialists for use at their MRI preparation session.
Statistical Analysis:
The dose of IN-Dex that produces mild to moderate sedation in 90% of subjects will be calculated using the pooled adjacent violators algorithm (PAVA) and bootstrap methods will be used to calculate the 95% confidence limits.
- Conditions
- MRI Sedation
- Being tested
- Dexmedetomidine
- Keywords
- dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Highly selective alpha-2 adrenergic agonist with sedative properties.
| Study group | Role | What they receive |
|---|---|---|
| Intra-nasal dexmedetomidine | Experimental | A single dose of dexmedetomidine, determined by a biased coin algorithm (min: 1 mcg/kg; max: 4 mcg/kg or 200mcg), will be delivered intranasally 45min before an MRI scan. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose
The intranasal dexmedetomidine dose in mcg/kg that produces successful completion of MRI scan with acceptable MRI image quality in 90% of individuals (ED 90).
Measured: Immediately after completion of the MRI scan.
Secondary outcomes (4)
Uninterrupted scans
Total number of scans that were able to be completed without interruptions
Measured: Immediately after completion of the MRI scan.
Respirator support
Total number of occurrences of respiratory support
Measured: During MRI scan
Adverse events
Occurrence of haemodynamic disturbance (bradycardia: absolute heart rate ≤ 40 bpm, hypertension: relative mean arterial pressure ≥ 50% baseline, hypotension: relative mean arterial pressure ≤ 50% baseline)
Measured: During MRI scan
modified Yale Preoperative Anxiety Scale (mYPAS)
Pre-procedure mYPAS score. The scale is a total summed score (4-22) of 5 areas; Activity (1-4), Vocalizations (1-6), Emotional expressivity (1-4), state of apparent arousal (1-4), and use of parents (1-4). A lower score represents a lower level of anxiety.
Measured: Immediately before administration of intranasal dexmedetomidine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study startFeb 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRI SedationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose finding
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- British Columbia Children's Hospital
- Responsible party
- Principal investigator, Mark Ansermino, University of British Columbia
- Investigators
- Mark Ansermino, FRCA, Principal investigator, BC Children's Hospital, Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806777
- Sponsor's protocol ID
- H18-02794
- Acronym
- DexmedMRI
- Status last verified
- Jan 2019
- First submitted
- 14 Jan 2019
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-nasal Dexmedetomidine for Children Undergoing MRI Imaging
- ClinicalTrials.gov ID
- NCT03806777
- Acronym / sponsor ID
- DexmedMRI / H18-02794
- Conditions
- MRI Sedation
- Keywords
- dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- British Columbia Children's Hospital
- Study start
- Feb 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 16 Jan 2019 (actual)
- 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 aims to assess the use of intranasal dexmedetomidine (IN-dex) as a sole agent in aiding the successful completion of a MRI scans in children. Dexmedetomidine, a routinely used anesthetic agent in our institution, has many benefits including sedation with neuro-protective and respiratory sparing features. We will test its effectiveness in completing MRI scans in children that would otherwise be given a full general anesthetic.
Detailed description
Purpose:
To assess the use of IN-dex as a sole agent in aiding the successful completion of a MRI scan in children.
Hypothesis:
We hypothesize that the optimal dose for IN-dex to produce appropriate sedation for MRI will be between 1 and 3 mcg/kg. We also hypothesize that this dose will be lower in the older age group.
Justification:
The dose required for IN-dex to enable safe sedation for MRI scanning as a sole agent is undetermined at present. This study will enable us to find the optimal dose for effective sedation for MRI scanning in a range of age groups. This will avoid the need for propofol and remifentanil general anesthesia (that is the current standard of care) in this group of patients. Our motivation for avoiding general anesthesia is that there is ongoing concern that general anesthesia causes long term neurocognitive effects in children. Finally, identifying a safe yet effective dose of IN-dex, which can be nurse-administered, will also allow us to improve access to MRI scans that are limited by the access to general anesthesia.
Objectives:
- To determine the dose of IN-dex that, when used as a sole agent, produces minimal to moderate sedation that is adequate for successful completion of MRI in children with >90% effectiveness.
- To explore the logistics of a nurse-administered sedation protocol to increase access to the MRI.
Research Design:
We propose a dose finding study of IN-dex using the biased coin design (BCD) method in three different age groups (3 to <8 years, 8 to <12 years, 12 to <19 years). The study specific interventions will include identification of children appropriate for the study following detailed assessment using a scoring system developed by our Child Life specialists for use at their MRI preparation session.
Statistical Analysis:
The dose of IN-Dex that produces mild to moderate sedation in 90% of subjects will be calculated using the pooled adjacent violators algorithm (PAVA) and bootstrap methods will be used to calculate the 95% confidence limits.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose finding
| Arm | Type | Receives |
|---|---|---|
| Intra-nasal dexmedetomidine | Experimental | Drug: DexmedetomidineA single dose of dexmedetomidine, determined by a biased coin algorithm (min: 1 mcg/kg; max: 4 mcg/kg or 200mcg), will be delivered intranasally 45min before an MRI scan. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- ASA 1 or 2
- Scheduled for elective MRI scan on the general anesthesia list
- Child Life MRI simulation score of 6-10 (Figure 1)
- Age 3 - 18
Key exclusion criteria (7 listed)
- Taking existing opioid, sedative, or cannabinoid medication
- Severe learning disability defined as the inability to follow simple commands
- Severe Cardiac disease
- Chronic hypertension
- Allergy to dexmedetomidine
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: PrecedexHighly selective alpha-2 adrenergic agonist with sedative properties. | Drug | Intra-nasal dexmedetomidine |
Primary outcome
Dose
Time frame: Immediately after completion of the MRI scan.
The intranasal dexmedetomidine dose in mcg/kg that produces successful completion of MRI scan with acceptable MRI image quality in 90% of individuals (ED 90).
4 secondary outcomes
Uninterrupted scans
Time frame: Immediately after completion of the MRI scan.
Respirator support
Time frame: During MRI scan
Adverse events
Time frame: During MRI scan
modified Yale Preoperative Anxiety Scale (mYPAS)
Time frame: Immediately before administration of intranasal dexmedetomidine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Pediatric Anesthesia Research Team websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for MRI Sedation
RecruitingPhase 4
Propofol-Only Versus Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging
MRI Sedation, Pediatric Sedation
Enrolling by invitationPhase 2
Assessing Covert Consciousness During Dexmedetomidine and Ketamine Sedation: An fMRI Study
Healthy, Covert Consciousness
RecruitingEarly Phase 1
Ketamine and Propofol NeuroImaging
Anesthesia, Pain
RecruitingEarly Phase 1
Remimazolam NeuroImaging
Anesthesia, Pain
Recruiting
Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring
Procedural Sedation and Analgesia, Pediatric ALL
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.
Mark Ansermino, FRCA principal investigator
BC Children's Hospital, Department of Anesthesia
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with MRI Sedation, run by University of British Columbia.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew K Poznikoff, BSc (604-875-2000 ext. 1989, andrew.poznikoff@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose (time frame: Immediately after completion of the MRI scan.). 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 25 Jan 2019.