Comparison of Outcomes During MRI Sedation With Midazolam-dexmedetomidine Versus Ketamine-dexmedetomidine



Status:Terminated
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any - 18
Updated:4/17/2018
Start Date:August 2014
End Date:March 2018

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COMPARISON OF OUTCOMES DURING MRI SEDATION WITH MIDAZOLAM-DEXMEDETOMIDINE VERSUS KETAMINE-DEXMEDETOMIDINE

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

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.

Inclusion Criteria:

1. Inpatient at Kosair Children's Hospital.

2. Order placed by treating team for MRI of the brain with sedation.

3. Age less than or equal to 18 years.

4. Plan to sedate with dexmedetomidine, regardless of study participation.

Exclusion Criteria:

1. Previous adverse reaction to dexmedetomidine or clonidine

2. Current use of clonidine as a routine medication

3. Concurrent use of a heart-rate decreasing medication (digoxin, propranolol)

4. Contraindication to ketamine use

- Intracranial hypertension or traumatic brain injury

- Intraocular hypertension of eye trauma

- Pulmonary hypertension requiring medical management

5. Planned additional procedure during the sedation encounter (non-brain MRI, lumbar
puncture, EEG etc)
We found this trial at
1
site
500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: John W. Berkenbosch, M.D.
Phone: 502-629-5820
University of Louisville The University of Louisville is a state supported research university located in...
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mi
from
Louisville, KY
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