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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 : Recruiting
First Posted : May 2, 2014
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):

April 23, 2014
May 2, 2014
May 4, 2017
August 2014
December 2017   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT02129426 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Comparison of Outcomes During MRI Sedation With Midazolam-dexmedetomidine Versus Ketamine-dexmedetomidine
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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Sedation
  • Drug: Ketamine
  • Drug: Midazolam
  • Drug: Dexmedetomidine
  • Experimental: Dexmedetomidine and Ketamine
    Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.
    Interventions:
    • Drug: Ketamine
    • Drug: Dexmedetomidine
  • Active Comparator: Dexmedetomidine and Midazolam
    Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.
    Interventions:
    • Drug: Midazolam
    • Drug: Dexmedetomidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
December 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
No
Contact: John W. Berkenbosch, M.D. 502-629-5820 john.berkenbosch@louisville.edu
Contact: KCPCRU UofL 502-629-5820 kcpcru@louisville.edu
United States
 
 
NCT02129426
Ket-Dex/M-Dex MRI
No
Not Provided
Not Provided
John W Berkenbosch, University of Louisville
University of Louisville
Not Provided
Principal Investigator: John W. Berkenbosch, M.D. University of Louisville
University of Louisville
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP