Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

Ketamine

Brief Summary

This is an interventional study on Duchenne muscular dystrophy patients who will be receiving sedation for a muscle biopsy as part of another study.

Intervention / Treatment

  • Ketamine (DRUG)
    1 mg/kg IV, additional doses of 0.5 mg/kg as needed
  • Dexmedetomidine (DRUG)
    0.5 mcg/kg/hr IV

Condition or Disease

  • Duchenne Muscular Dystrophy

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: Child, Adult, Older Adult
    Enrollment: 53 (ACTUAL)
    Funded by: Other
    Allocation: Non-Randomized
    Primary Purpose: Treatment

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    Clinical Trial Dates

    Start date: Aug 01, 2011
    Primary Completion: Apr 01, 2013 ACTUAL
    Completion Date: Jun 01, 2013 ACTUAL
    Study First Posted: Jul 20, 2012 ESTIMATED
    Results First Posted: Feb 26, 2015 ESTIMATED
    Last Updated: Feb 25, 2015

    Sponsors / Collaborators

    Lead Sponsor: Nationwide Children's Hospital
    Responsible Party: N/A

    Location

    Columbus, Ohio, USA

    Participant Groups

    • Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.

    • Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.

    Eligibility Criteria

    Sex: Male
    Age Groups: Child / Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Patients undergoing a muscle biopsy for IRB11-00203.

    Primary Outcomes

    • The depth of sedation was judged using the University of Michigan Sedation Scale (UMSS). The score ranges from zero, awake and alert, to four, unarousable. A score of three, deeply sedated, or more was considered to be an appropriate level of sedation for the procedure.

    Secondary Outcomes

    • Difference in heart rate from baseline to immediately following infusion of dexmedetomidine loading dose.

    • Change in MAP from baseline measurement to immediately post dexmedetomidine infusion measured via blood pressure cuff.

    • Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion.

    • Change in end-tidal carbon dioxide from baseline measurement to immediately post dexmedetomidine infusion.

    More Details

    NCT Number: NCT01645098
    Other IDs: IRB11-00532
    Study URL: https://clinicaltrials.gov/study/NCT01645098
    Last updated: Sep 29, 2023