Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy
1 other identifier
interventional
53
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 8, 2012
CompletedFirst Posted
Study publicly available on registry
July 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
February 26, 2015
CompletedFebruary 26, 2015
February 1, 2015
1.7 years
June 8, 2012
February 4, 2015
February 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Sedation Score of 3-4
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.
Immediately prior to incision
Secondary Outcomes (4)
Heart Rate Change After Dexmedetomidine Loading Dose
Baseline to immediately post dexmedetomidine infusion.
Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose
Baseline to immediately post dexmedetomidine infusion.
Oxygen Saturation Change After Dexmedetomidine Loading Dose
Baseline to immediately post dexmedetomidine infusion.
EtCO2 Change After Dexmedetomidine Loading Dose
Baseline to immediately post dexmedetomidine infusion.
Study Arms (2)
Dexmedetomidine 1 mcg/kg
EXPERIMENTALPatients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.
Dexmedetomidine 0.5 mcg/kg
EXPERIMENTALPatients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.
Interventions
1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Eligibility Criteria
You may qualify if:
- Patients undergoing a muscle biopsy for IRB11-00203.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marco Corridore, MD
- Organization
- Nationwide Children's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph D Tobias, MD
Nationwide Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman, Dept. of Anesthesiology & Pain Medicine
Study Record Dates
First Submitted
June 8, 2012
First Posted
July 20, 2012
Study Start
August 1, 2011
Primary Completion
April 1, 2013
Study Completion
June 1, 2013
Last Updated
February 26, 2015
Results First Posted
February 26, 2015
Record last verified: 2015-02