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

Ketamine

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

Intervention / Treatment

  • Ketamine (DRUG)
    Sedation medication
  • Midazolam (DRUG)
    Sedation medication
  • Dexmedetomidine (DRUG)
    Sedation medication

Condition or Disease

  • Sedation

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: up to 18 Years   (Child, Adult)
    Enrollment: 21 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Health Services Research

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Aug 01, 2014 ACTUAL
    Primary Completion: Mar 01, 2018 ACTUAL
    Completion Date: Mar 01, 2018 ACTUAL
    Study First Posted: May 02, 2014 ESTIMATED
    Results First Posted: Jul 07, 2021 ACTUAL
    Last Updated: Jul 12, 2021

    Sponsors / Collaborators

    Lead Sponsor: University of Louisville
    Responsible Party: N/A

    Location

    Louisville, Kentucky, USA

    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.

    Participant Groups

    • Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.

    • Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.

    Eligibility Criteria

    Sex: All
    Maximum Age: 18
    Age Groups: Child / Adult
    Healthy Volunteers: Yes

    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)

    Primary Outcomes

    • number of participants developing hypotension and or bradycardia

    Secondary Outcomes

    • Change in heart rate from baseline.

    • Change in blood pressure from baseline.

    • This study will compare the number of participants with adverse recovery-related behaviors, based on the PAED scores, between the 2 treatment arms.

    More Details

    NCT Number: NCT02129426
    Other IDs: Ket-Dex/M-Dex MRI
    Study URL: https://clinicaltrials.gov/study/NCT02129426
    Last updated: Sep 29, 2023