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completed

Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

key information

study id #: NCT01645098

condition: Duchenne Muscular Dystrophy

status: completed

purpose:

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: Ketamine, Dexmedetomidine

mechanism of action: Sedation during moderately painful procedures

results: https://clinicaltrials.gov/ct2/show/results/NCT01645098

last updated: November 22, 2018

study details

start date: August 2011

estimated completion: June 2013

phase of development: N/A

size / enrollment: 53

primary outcomes:

  • Time to Sedation Score of 3-4 [ Time Frame: Immediately prior to incision ]
    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:

  • Heart Rate Change After Dexmedetomidine Loading Dose [ Time Frame: Baseline to immediately post dexmedetomidine infusion. ]
    Difference in heart rate from baseline to immediately following infusion of dexmedetomidine loading dose.
  • Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose [ Time Frame: Baseline to immediately post dexmedetomidine infusion. ]
    Change in MAP from baseline measurement to immediately post dexmedetomidine infusion measured via blood pressure cuff.
  • Oxygen Saturation Change After Dexmedetomidine Loading Dose [ Time Frame: Baseline to immediately post dexmedetomidine infusion. ]
    Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion.
  • EtCO2 Change After Dexmedetomidine Loading Dose [ Time Frame: Baseline to immediately post dexmedetomidine infusion. ]
    Change in end-tidal carbon dioxide from baseline measurement to immediately post dexmedetomidine infusion.

inclusion criteria:
Patients undergoing a muscle biopsy for IRB11-00203.

study contacts

sponsor: Nationwide Children's Hospital

investigators: Joseph D Tobias, MD

locations: United States