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Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT01645098
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Tracking Information
First Submitted Date  ICMJE June 8, 2012
First Posted Date  ICMJE July 20, 2012
Results First Submitted Date  ICMJE February 4, 2015
Results First Posted Date  ICMJE February 26, 2015
Last Update Posted Date February 26, 2015
Study Start Date  ICMJE August 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
Level of sedation [ Time Frame: Immediately prior to incision ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
  • Heart rate [ Time Frame: On induction; immediately prior to incision; every minute during muscle biospsy, an expected average of 30 minutes ]
  • Blood pressure [ Time Frame: On induction; immediately prior to incision; every 3 minutes during muscle biopsy, an expected average of 30 minutes ]
  • Oxygen saturation [ Time Frame: On induction; immediately prior to incision; every minute during muscle biospsy, an expected average of 30 minutes ]
  • EtCO2 [ Time Frame: On induction; immediately prior to incision; every minute during muscle biospsy, an expected average of 30 minutes ]
    End-tidal carbon dioxide
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy
Official Title  ICMJE Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Duchenne Muscular Dystrophy
Intervention  ICMJE
  • Drug: Ketamine
    1 mg/kg IV, additional doses of 0.5 mg/kg as needed
  • Drug: Dexmedetomidine
    0.5 mcg/kg/hr IV
Study Arms  ICMJE
  • Experimental: Dexmedetomidine 1 mcg/kg
    Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.
    Interventions:
    • Drug: Ketamine
    • Drug: Dexmedetomidine
  • Experimental: Dexmedetomidine 0.5 mcg/kg
    Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.
    Interventions:
    • Drug: Ketamine
    • Drug: Dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2015)
53
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2012)
25
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing a muscle biopsy for IRB11-00203.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01645098
Other Study ID Numbers  ICMJE IRB11-00532
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph D. Tobias, Nationwide Children's Hospital
Study Sponsor  ICMJE Nationwide Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph D Tobias, MD Nationwide Children's Hospital
PRS Account Nationwide Children's Hospital
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP