Back to resultsSedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy
Primary Purpose
Duchenne Muscular Dystrophy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Duchenne Muscular Dystrophy
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing a muscle biopsy for IRB11-00203.
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dexmedetomidine 1 mcg/kg
Dexmedetomidine 0.5 mcg/kg
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Heart Rate Change After Dexmedetomidine Loading Dose
Difference in heart rate from baseline to immediately following infusion of dexmedetomidine loading dose.
Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose
Change in MAP from baseline measurement to immediately post dexmedetomidine infusion measured via blood pressure cuff.
Oxygen Saturation Change After Dexmedetomidine Loading Dose
Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion.
EtCO2 Change After Dexmedetomidine Loading Dose
Change in end-tidal carbon dioxide from baseline measurement to immediately post dexmedetomidine infusion.
Full Information
NCT ID
NCT01645098
First Posted
June 8, 2012
Last Updated
February 25, 2015
Sponsor
Nationwide Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01645098
Brief Title
Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy
Official Title
Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duchenne Muscular Dystrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine 1 mcg/kg
Arm Type
Experimental
Arm Description
Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.
Arm Title
Dexmedetomidine 0.5 mcg/kg
Arm Type
Experimental
Arm Description
Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
0.5 mcg/kg/hr IV
Primary Outcome Measure Information:
Title
Time to Sedation Score of 3-4
Description
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.
Time Frame
Immediately prior to incision
Secondary Outcome Measure Information:
Title
Heart Rate Change After Dexmedetomidine Loading Dose
Description
Difference in heart rate from baseline to immediately following infusion of dexmedetomidine loading dose.
Time Frame
Baseline to immediately post dexmedetomidine infusion.
Title
Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose
Description
Change in MAP from baseline measurement to immediately post dexmedetomidine infusion measured via blood pressure cuff.
Time Frame
Baseline to immediately post dexmedetomidine infusion.
Title
Oxygen Saturation Change After Dexmedetomidine Loading Dose
Description
Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion.
Time Frame
Baseline to immediately post dexmedetomidine infusion.
Title
EtCO2 Change After Dexmedetomidine Loading Dose
Description
Change in end-tidal carbon dioxide from baseline measurement to immediately post dexmedetomidine infusion.
Time Frame
Baseline to immediately post dexmedetomidine infusion.
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing a muscle biopsy for IRB11-00203.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph D Tobias, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy
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