SedationNCT02129426
Comparison of Outcomes During MRI Sedation With Midazolam-dexmedetomidine Versus Ketamine-dexmedetomidine
A study testing Ketamine, Midazolam and Dexmedetomidine in people with Sedation, run by University of Louisville at 1 site in United States.
Trial summary
This study will compare 2 different sedation drugs (Ketamine and Midazolam) when they are used with another sedating medicine called Dexmedetomidine for MRI sedation. This study hopes to measure the impact each drug has on what happens during and after MRI sedation with Dexmedetomidine Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Sedation
- What is being tested?
- Ketamine, Midazolam and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Inpatient at Kosair Children's Hospital.
- Order placed by treating team for MRI of the brain with sedation.
- Age less than or equal to 18 years.
- Plan to sedate with dexmedetomidine, regardless of study participation.
Who cannot join
- Previous adverse reaction to dexmedetomidine or clonidine
- Current use of clonidine as a routine medication
- Concurrent use of a heart-rate decreasing medication (digoxin, propranolol)
- Contraindication to ketamine use
- Intracranial hypertension or traumatic brain injury
- Intraocular hypertension of eye trauma
- Pulmonary hypertension requiring medical management
- Planned additional procedure during the sedation encounter (non-brain MRI, lumbar puncture, EEG etc)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
This study will compare 2 different sedation drugs (Ketamine and Midazolam) when they are used with another sedating medicine called Dexmedetomidine for MRI sedation. This study hopes to measure the impact each drug has on what happens during and after MRI sedation with Dexmedetomidine
Read the detailed description
The will be a randomized, double-blind, prospective study. All patients referred to UCSS for brain MRI and for whom dexmedetomidine would otherwise be the sedation regimen of choice will be eligible for enrollment. The investigators propose to limit the study to patients undergoing only brain MRI as these studies are of a predictable length (25-30 minutes); therefore the sedation regimen can be more easily standardized. Parents of eligible patients would be approached prior to or during the pre-sedation assessment and told about the study and, if they agree to enroll, informed consent would be obtained. Assent will be obtained from children 7 years of age and greater, if they are otherwise developmentally capable of giving assent. The goal is to enroll 50 subjects (25 per treatment group) which would be sufficient to detect a 25% or greater difference in the mean maximal heart rate or blood pressure decrease from baseline between the 2 groups.
Following consent, subjects would be randomized to be sedated with either midazolam-dexmedetomidine or ketamine-dexmedetomidine and, upon achieving an appropriate depth of sedation, undergo their MRI. Monitoring during the MRI and subsequent recovery would occur in compliance with the current Norton Children's Hospital Sedation policy. Recovery-related behavior would be assessed using the Pediatric Anesthesia Emergence Delirium Scale.
- Conditions
- Sedation
- Being tested
- Ketamine, Midazolam, Dexmedetomidine
- Keywords
- Sedation, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Sedation medication
MidazolamDrug
Sedation medication
DexmedetomidineDrug
Sedation medication
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine and Ketamine | Experimental | Subjects will already be getting Dexmedetomidine and Ketamine for their routine care. Receives: Drug: Ketamine; Drug: Dexmedetomidine |
| Dexmedetomidine and Midazolam | Active comparator | Subjects will already be getting Dexmedetomidine and Midazolam for their routine care. Receives: Drug: Midazolam; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Hypotension and/or Bradycardia During Sedation and Recovery (Generally 2-3 Hours)
number of participants developing hypotension and or bradycardia
Measured: a total of 2-3 hours during sedation and recovery.
Secondary outcomes (3)
Percent Change in Heart Rate From Baseline
Change in heart rate from baseline.
Measured: during sedation and recovery (generally 2-3 hours)
Percent Change in Blood Pressure From Baseline
Change in blood pressure from baseline.
Measured: during sedation and recovery (generally 2-3 hours)
The Number of Participants With Adverse Recovery-related Behaviors During Sedation Recovery
This study will compare the number of participants with adverse recovery-related behaviors, based on the PAED scores, between the 2 treatment arms.
Measured: Recovery-related behaviors will be specifically measured using the "Pediatric Anesthesia Emergence Delirium (PAED)" scale every 5 minutes from procedure completion until sedation recovery is complete (usually less than 2 hrs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2018
- Study completionMar 2018
Why it stopped: Unable to recruit the adequate number of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John W Berkenbosch, University of Louisville
- Investigators
- John W. Berkenbosch, M.D., Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129426
- Sponsor's protocol ID
- Ket-Dex/M-Dex MRI
- Status last verified
- Jul 2021
- First submitted
- 23 Apr 2014
- Last updated
- 14 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes During MRI Sedation With Midazolam-dexmedetomidine Versus Ketamine-dexmedetomidine
- ClinicalTrials.gov ID
- NCT02129426
- Acronym / sponsor ID
- Ket-Dex/M-Dex MRI
- Conditions
- Sedation
- Keywords
- Sedation, MRI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit the adequate number of subjects
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 2 May 2014 (estimated)
- Results
- Posted 7 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare 2 different sedation drugs (Ketamine and Midazolam) when they are used with another sedating medicine called Dexmedetomidine for MRI sedation. This study hopes to measure the impact each drug has on what happens during and after MRI sedation with Dexmedetomidine
Detailed description
The will be a randomized, double-blind, prospective study. All patients referred to UCSS for brain MRI and for whom dexmedetomidine would otherwise be the sedation regimen of choice will be eligible for enrollment. The investigators propose to limit the study to patients undergoing only brain MRI as these studies are of a predictable length (25-30 minutes); therefore the sedation regimen can be more easily standardized. Parents of eligible patients would be approached prior to or during the pre-sedation assessment and told about the study and, if they agree to enroll, informed consent would be obtained. Assent will be obtained from children 7 years of age and greater, if they are otherwise developmentally capable of giving assent. The goal is to enroll 50 subjects (25 per treatment group) which would be sufficient to detect a 25% or greater difference in the mean maximal heart rate or blood pressure decrease from baseline between the 2 groups.
Following consent, subjects would be randomized to be sedated with either midazolam-dexmedetomidine or ketamine-dexmedetomidine and, upon achieving an appropriate depth of sedation, undergo their MRI. Monitoring during the MRI and subsequent recovery would occur in compliance with the current Norton Children's Hospital Sedation policy. Recovery-related behavior would be assessed using the Pediatric Anesthesia Emergence Delirium Scale.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine and Ketamine | Experimental | Drug: Ketamine, Drug: DexmedetomidineSubjects will already be getting Dexmedetomidine and Ketamine for their routine care. |
| Dexmedetomidine and Midazolam | Active comparator | Drug: Midazolam, Drug: DexmedetomidineSubjects will already be getting Dexmedetomidine and Midazolam for their routine care. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Inpatient at Kosair Children's Hospital.
- Order placed by treating team for MRI of the brain with sedation.
- Age less than or equal to 18 years.
- Plan to sedate with dexmedetomidine, regardless of study participation.
Key exclusion criteria (8 listed)
- Previous adverse reaction to dexmedetomidine or clonidine
- Current use of clonidine as a routine medication
- Concurrent use of a heart-rate decreasing medication (digoxin, propranolol)
- Contraindication to ketamine use
- Planned additional procedure during the sedation encounter (non-brain MRI, lumbar puncture, EEG etc)
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 |
|---|---|---|
| KetamineSedation medication | Drug | Dexmedetomidine and Ketamine |
| MidazolamSedation medication | Drug | Dexmedetomidine and Midazolam |
| DexmedetomidineSedation medication | Drug | Dexmedetomidine and Ketamine, Dexmedetomidine and Midazolam |
Primary outcome
The Number of Participants With Hypotension and/or Bradycardia During Sedation and Recovery (Generally 2-3 Hours)
Time frame: a total of 2-3 hours during sedation and recovery.
number of participants developing hypotension and or bradycardia
3 secondary outcomes
Percent Change in Heart Rate From Baseline
Time frame: during sedation and recovery (generally 2-3 hours)
Percent Change in Blood Pressure From Baseline
Time frame: during sedation and recovery (generally 2-3 hours)
The Number of Participants With Adverse Recovery-related Behaviors During Sedation Recovery
Time frame: Recovery-related behaviors will be specifically measured using the "Pediatric Anesthesia Emergence Delirium (PAED)" scale every 5 minutes from procedure completion until sedation recovery is complete (usually less than 2 hrs)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John W. Berkenbosch, M.D. principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine, Midazolam and Dexmedetomidine in people with Sedation, run by University of Louisville 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 8 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 14 Jul 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Number of Participants With Hypotension and/or Bradycardia During Sedation and Recovery (Generally 2-3 Hours) (time frame: a total of 2-3 hours during sedation and recovery.). 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 Jul 2021.