Magnetic Resonance ImagingPhase 1NCT00894751
Two Anesthetic Techniques in Magnetic Resonance Imaging (MRI)
A Phase 1 study testing dexmedetomidine and propofol in people with Magnetic Resonance Imaging and Anesthesia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The goal of this study is to determine if there is a significant difference in the quality of care between the investigators' two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI. Read more about this study
- Who is it for?
- Ages 12 months to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance Imaging, Anesthesia
- What is being tested?
- dexmedetomidine and propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2011
- Phase
- Phase 1
- 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 12 months to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects presenting as out-patients, scheduled to receive an anesthetic for MRI of body (spine, chest, abdomen, and/or pelvis) and/or extremity (arm and/or leg).
- The subject must be a candidate for both anesthetic techniques. This decision will be made by a staff member of the Department of Anesthesiology. This staff member will not be a member of the study team and will obtain the consent for Anesthesia.
- The subjects must be 12 months to 7 years (inclusive of the seventh year).
- The subject's legally authorized representative has given written informed consent to participate in the study.
Who cannot join
- The subject is residing in the Pediatric Intensive Care Unit, the Cardiac Intensive Care Unit, or Neonatal Intensive Care Unit.
- Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine).
- The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
- The subject has life-threatening, medical conditions (American Society of Anesthesiologists Physical Status 4, 5 or 6).
- The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is.
- For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
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- The subject is allergic to or has a contraindication to any of the drugs used in the study.
- The subject has previously been treated under this protocol.
- The subject has a tracheostomy or other mechanical airway device.
- The subject has received within the past 12 hours an oral or intravenous alpha-adrenergic, beta-adrenergic agonist, or antagonist drugs (e.g., clonidine, propranolol, albuterol).
- The subject is not scheduled to receive anesthesia-sedation care for the MRI.
- The subject received one of the anesthetic regimens for the same MRI during the past six months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: A Qualitative Comparison of Two Anesthetic Techniques in Children Undergoing Magnetic Resonance Imaging
The goal of this study is to determine if there is a significant difference in the quality of care between the investigators' two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI. Quality of care will be measured by time spent in the MRI room as well as parental satisfaction, frequency of interruptions of the MRI scan, incidence-severity of respiratory complications, post anesthesia agitation, and time spent in the induction room, MRI room, and Post-Anesthesia Care Unit (PACU).
- Conditions
- Magnetic Resonance Imaging, Anesthesia
- Being tested
- dexmedetomidine, propofol
- Keywords
- dexmedetomidine and propofol for MRI, quality of care between two anesthetic agents for MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
dexmedetomidine general anesthesia for MRI
propofolDrug
propofol general anesthesia for MRI
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Active comparator | Determine if there is a significant difference in the quality of care between our two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI. Receives: Drug: dexmedetomidine |
| propofol | Active comparator | Determine if there is a significant difference in the quality of care between our two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI. Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome variable will be the time spent in the MRI room
Measured: 2 years
Secondary outcomes (1)
Secondary outcome variables include incidence-severity of respiratory complications
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionDec 2011
Why it stopped: low enrollment and high participant withdraw
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894751
- Sponsor's protocol ID
- 2008-0281
- Status last verified
- Aug 2020
- First submitted
- 6 May 2009
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Comparison of Two Anesthetic Techniques in Children Undergoing Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00894751
- Acronym / sponsor ID
- 2008-0281
- Conditions
- Magnetic Resonance Imaging, Anesthesia
- Keywords
- dexmedetomidine and propofol for MRI, quality of care between two anesthetic agents for MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment and high participant withdraw
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 May 2009 (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 goal of this study is to determine if there is a significant difference in the quality of care between the investigators' two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI. Quality of care will be measured by time spent in the MRI room as well as parental satisfaction, frequency of interruptions of the MRI scan, incidence-severity of respiratory complications, post anesthesia agitation, and time spent in the induction room, MRI room, and Post-Anesthesia Care Unit (PACU).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Active comparator | Drug: dexmedetomidineDetermine if there is a significant difference in the quality of care between our two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI. |
| propofol | Active comparator | Drug: propofolDetermine if there is a significant difference in the quality of care between our two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI. |
Who may qualify
- Ages
- 12 months to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subjects presenting as out-patients, scheduled to receive an anesthetic for MRI of body (spine, chest, abdomen, and/or pelvis) and/or extremity (arm and/or leg).
- The subject must be a candidate for both anesthetic techniques. This decision will be made by a staff member of the Department of Anesthesiology. This staff member will not be a member of the study team and will obtain the consent for Anesthesia.
- The subjects must be 12 months to 7 years (inclusive of the seventh year).
- The subject's legally authorized representative has given written informed consent to participate in the study.
Key exclusion criteria (12 listed)
- The subject is residing in the Pediatric Intensive Care Unit, the Cardiac Intensive Care Unit, or Neonatal Intensive Care Unit.
- Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine).
- The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
- The subject has life-threatening, medical conditions (American Society of Anesthesiologists Physical Status 4, 5 or 6).
- The subject is allergic to or has a contraindication to any of the drugs used in the study.
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 |
|---|---|---|
| dexmedetomidinedexmedetomidine general anesthesia for MRI | Drug | dexmedetomidine |
| propofolpropofol general anesthesia for MRI | Drug | propofol |
Primary outcome
The primary outcome variable will be the time spent in the MRI room
Time frame: 2 years
1 secondary outcome
Secondary outcome variables include incidence-severity of respiratory complications
Time frame: 2 years
Results and safety
The study was stopped early (reason given: low enrollment and high participant withdraw). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dexmedetomidine and propofol in people with Magnetic Resonance Imaging and Anesthesia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 12 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: stopped early, as of the sponsor's last update on 21 Sep 2020. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: low enrollment and high participant withdraw). Results are not available in the source record.
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 primary outcome variable will be the time spent in the MRI room (time frame: 2 years). 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 21 Sep 2020.