Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

• 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: Nationwide Children's Hospital
• Information provided by (Responsible Party): Joseph D. Tobias, Nationwide Children's Hospital

Tracking Information

• First Submitted Date: June 8, 2012
• First Posted Date: July 20, 2012
• Results First Submitted Date: February 4, 2015
• Results First Posted Date: February 26, 2015
• Last Update Posted Date: February 26, 2015
• Study Start Date: August 2011
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: July 19, 2012): Level of sedation [ Time Frame: Immediately prior to incision ]

Current Secondary Outcome Measures (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 (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: Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Duchenne Muscular Dystrophy

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 25, 2015): 53
• Original Estimated Enrollment (submitted: July 19, 2012): 25
• Actual Study Completion Date: June 2013
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients undergoing a muscle biopsy for IRB11-00203.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01645098
• Other Study ID Numbers: IRB11-00532
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Joseph D. Tobias, Nationwide Children's Hospital
• Study Sponsor: Nationwide Children's Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Joseph D Tobias, MD; Nationwide Children's Hospital

• PRS Account: Nationwide Children's Hospital
• Verification Date: February 2015