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

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ClinicalTrials.gov Identifier: NCT02129426
Recruitment Status : Terminated (Unable to recruit the adequate number of subjects)
First Posted : May 2, 2014
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
John W Berkenbosch, University of Louisville

Brief 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

Condition or disease Intervention/treatment Phase
Sedation Drug: Ketamine Drug: Midazolam Drug: Dexmedetomidine Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: COMPARISON OF OUTCOMES DURING MRI SEDATION WITH MIDAZOLAM-DEXMEDETOMIDINE VERSUS KETAMINE-DEXMEDETOMIDINE
Actual Study Start Date : August 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dexmedetomidine and Ketamine
Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.
Drug: Ketamine Drug: Dexmedetomidine
Active Comparator: Dexmedetomidine and Midazolam
Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.
Drug: Midazolam Drug: Dexmedetomidine



Primary Outcome Measures :
  1. The incidence of hypotension and/or bradycardia during sedation [ Time Frame: parameters (blood pressure, heart rate) will be measured every 5 minutes from start of the sedation until recovery has been completed (usually less than 2 hrs). ]
    The study will compare the incidences of hypotension (Systolic Blood Pressure (SBP) <5% for age/gender) and/or bradycardia (Heart Rate (HR) <70 in infants, HR <60 in children 12-23 mos of age, HR <50 for subjects 24 mos of age and older) that occur within each treatment arm as well as measure the percent maximal decrease in HR and SBP from baseline in each subject and compare mean decreases in these measures between treatment groups).


Secondary Outcome Measures :
  1. The incidence of 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) ]
    This study will compare the incidence of adverse recovery-related behaviors, based on the PAED scores, between the 2 treatment arms.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129426


Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: John W. Berkenbosch, M.D. University of Louisville

Responsible Party: John W Berkenbosch, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT02129426     History of Changes
Other Study ID Numbers: Ket-Dex/M-Dex MRI
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: March 2018

Keywords provided by John W Berkenbosch, University of Louisville:
Sedation
MRI

Additional relevant MeSH terms:
Dexmedetomidine
Midazolam
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents