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Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy
study id #: NCT01645098
condition: Duchenne Muscular Dystrophy
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
last updated: November 22, 2018
start date: August 2011
estimated completion: June 2013
phase of development: N/A
size / enrollment: 53
- 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.
- 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.
Patients undergoing a muscle biopsy for IRB11-00203.
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