Dexmedetomidine and Ketamine in MRI

Ketamine

Brief Summary

The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and ketamine, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults. The results of this study will help in making the best decisions regarding the anesthesia medications used for sedation outside of the operating room.

Intervention / Treatment

  • Dexmedetomidine (DRUG)
    2 mc/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h
  • Ketamine (DRUG)
    Bolus dose 2 mg/kg after first set of research images are obtained

Condition or Disease

  • Magnetic Resonance Imaging

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 1 Year to 18 Years
    Enrollment: 22 (ESTIMATED)
    Funded by: Other
    Allocation: N/A
    Primary Purpose: Other

    Masking

    Clinical Trial Dates

    Start date: Jun 01, 2016
    Primary Completion: May 01, 2018 ACTUAL
    Completion Date: May 01, 2018 ACTUAL
    Study First Posted: Jan 12, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jul 23, 2019

    Sponsors / Collaborators

    Lead Sponsor: Children's Hospital Medical Center, Cincinnati
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Cincinnati, Ohio, USA

    Upper airway obstruction is a common problem in spontaneously breathing patients under anesthesia. This study is examining the effects of combining dexmedetomidine and ketamine on the muscle tone and airway configuration in children under anesthesia. The hypothesis is adding ketamine to dexmedetomidine will not significantly reduce airway caliber or morphology when compared to previously collected data using dexmedetomidine alone.

    Participant Groups

    • All patients will receive the same drugs. A loading dose of dexmedetomidine of 2 mcg/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h. Bolus dose 2 mg/kg of ketamine will be given after the initial set of research images have been taken.

    Eligibility Criteria

    Sex: All
    Minimum Age: 1
    Maximum Age: 18
    Age Groups: Child / Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Patient requires anesthesia for a MRI scan of the brain or MRI brain/spine
    * Patient must be 1 to 18 years of age
    * Patients legally authorized representative has given written informed consent to participate in the study

    Exclusion Criteria:

    * Allergy to dexmedetomidine or ketamine
    * History or obstructive sleep apnea
    * The patient has a life-threatening medical condition (ASA status 4, 5, or 6)
    * The patient is not scheduled to receive anesthesia sedation for the MRI
    * Patient has a history or a family history of malignant hyperthermia

    Primary Outcomes

    • MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan

    • MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan

    Secondary Outcomes

    • MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan

    • MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan

    • Patient movement during MRI Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
    • Episodes of low oxygen saturation Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
    • Placement of adjunct airway Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
    • Arterial blood pressure relative to baseline before dexmedetomidine is given Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
    • Heart rate relative to baseline before dexmedetomidine is given Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes

    More Details

    NCT Number: NCT02652507
    Other IDs: 2016-0106
    Study URL: https://clinicaltrials.gov/study/NCT02652507
    Last updated: Sep 29, 2023