Magnetic Resonance ImagingPhase 1NCT02652507
Dexmedetomidine and Ketamine in MRI
A Phase 1 study testing Dexmedetomidine and Ketamine in people with Magnetic Resonance Imaging, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and ketamine, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Magnetic Resonance Imaging
- What is being tested?
- Dexmedetomidine and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to May 2018
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient requires anesthesia for a MRI scan of the brain or MRI brain/spine
- Patient must be 1 to 18 years of age
- Patients legally authorized representative has given written informed consent to participate in the study
Who cannot join
- Allergy to dexmedetomidine or ketamine
- History or obstructive sleep apnea
- The patient has a life-threatening medical condition (ASA status 4, 5, or 6)
- The patient is not scheduled to receive anesthesia sedation for the MRI
- Patient has a history or a family history of malignant hyperthermia
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Effect of a Combination of Dexmedetomidine and Ketamine Anesthesia on Upper Airway Morphology in Children
The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and ketamine, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults.
The results of this study will help in making the best decisions regarding the anesthesia medications used for sedation outside of the operating room.
Read the detailed description
Upper airway obstruction is a common problem in spontaneously breathing patients under anesthesia. This study is examining the effects of combining dexmedetomidine and ketamine on the muscle tone and airway configuration in children under anesthesia. The hypothesis is adding ketamine to dexmedetomidine will not significantly reduce airway caliber or morphology when compared to previously collected data using dexmedetomidine alone.
- Conditions
- Magnetic Resonance Imaging
- Being tested
- Dexmedetomidine, Ketamine
- Keywords
- Sedation, MRI, Dexmedetomidine, Ketamine, General anesthesia, MRI of Brain, MRI of Brain/Spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
2 mc/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h
KetamineDrug
Bolus dose 2 mg/kg after first set of research images are obtained
| Study group | Role | What they receive |
|---|---|---|
| Anesthesia for MRI | Other | All patients will receive the same drugs.
A loading dose of dexmedetomidine of 2 mcg/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h. Bolus dose 2 mg/kg of ketamine will be given after the initial set of research images have been taken. Receives: Drug: Dexmedetomidine; Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of soft palate under anesthesia
MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan
Measured: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Measurement of base of tongue under anesthesia
MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan
Measured: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Secondary outcomes (7)
Anteroposterior dimension and transverse dimension of soft palate
MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan
Measured: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Anteroposterior dimension and transverse dimension of base of tongue
MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan
Measured: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Patient movement during MRI
Measured: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Episodes of low oxygen saturation
Measured: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Placement of adjunct airway
Measured: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Arterial blood pressure relative to baseline before dexmedetomidine is given
Measured: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Heart rate relative to baseline before dexmedetomidine is given
Measured: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2018
- Study completionMay 2018
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Mahmoud, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652507
- Sponsor's protocol ID
- 2016-0106
- Status last verified
- Jul 2019
- First submitted
- 8 Jan 2016
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Combination of Dexmedetomidine and Ketamine Anesthesia on Upper Airway Morphology in Children
- ClinicalTrials.gov ID
- NCT02652507
- Acronym / sponsor ID
- 2016-0106
- Conditions
- Magnetic Resonance Imaging
- Keywords
- Sedation, MRI, Dexmedetomidine, Ketamine, General anesthesia, MRI of Brain, MRI of Brain/Spine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 12 Jan 2016 (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 purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and ketamine, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults.
The results of this study will help in making the best decisions regarding the anesthesia medications used for sedation outside of the operating room.
Detailed description
Upper airway obstruction is a common problem in spontaneously breathing patients under anesthesia. This study is examining the effects of combining dexmedetomidine and ketamine on the muscle tone and airway configuration in children under anesthesia. The hypothesis is adding ketamine to dexmedetomidine will not significantly reduce airway caliber or morphology when compared to previously collected data using dexmedetomidine alone.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anesthesia for MRI | Other | Drug: Dexmedetomidine, Drug: KetamineAll patients will receive the same drugs. A loading dose of dexmedetomidine of 2 mcg/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h. Bolus dose 2 mg/kg of ketamine will be given after the initial set of research images have been taken. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient requires anesthesia for a MRI scan of the brain or MRI brain/spine
- Patient must be 1 to 18 years of age
- Patients legally authorized representative has given written informed consent to participate in the study
Key exclusion criteria (5 listed)
- Allergy to dexmedetomidine or ketamine
- History or obstructive sleep apnea
- The patient has a life-threatening medical condition (ASA status 4, 5, or 6)
- The patient is not scheduled to receive anesthesia sedation for the MRI
- Patient has a history or a family history of malignant hyperthermia
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 |
|---|---|---|
| Dexmedetomidine2 mc/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h | Drug | Anesthesia for MRI |
| KetamineBolus dose 2 mg/kg after first set of research images are obtained | Drug | Anesthesia for MRI |
Primary outcome
Measurement of soft palate under anesthesia
Time frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan
Measurement of base of tongue under anesthesia
Time frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan
7 secondary outcomes
Anteroposterior dimension and transverse dimension of soft palate
Time frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Anteroposterior dimension and transverse dimension of base of tongue
Time frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Patient movement during MRI
Time frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Episodes of low oxygen saturation
Time frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Placement of adjunct airway
Time frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Arterial blood pressure relative to baseline before dexmedetomidine is given
Time frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Heart rate relative to baseline before dexmedetomidine is given
Time frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
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 24 Jul 2019.
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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.
Mohamed Mahmoud, MD principal investigator
Children's Hospital Medical Center, Cincinnati
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 Ketamine in people with Magnetic Resonance Imaging, 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 3 inclusion and 5 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 24 Jul 2019. 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 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?
Measurement of soft palate under anesthesia (time frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes). The study lists 2 primary outcomes in all. 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 24 Jul 2019.