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Completed

NCT Number: NCT01645098

Sedation During Muscle Biopsy in Patients With 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.

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Key information

Conditions

Duchenne Muscular Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing a muscle biopsy for IRB11-00203.

Treatment and study plan

ketamine

Drug

1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine

Drug

0.5 mcg/kg/hr IV

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2012
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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