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Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Duchenne Muscular Dystrophy Drug: Ketamine Drug: Dexmedetomidine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy
Study Start Date : August 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : June 2013

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Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Ketamine
1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Drug: Dexmedetomidine
0.5 mcg/kg/hr IV
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.
 Drug: Ketamine
1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Drug: Dexmedetomidine
0.5 mcg/kg/hr IV


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing a muscle biopsy for IRB11-00203.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645098


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
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Principal Investigator: Joseph D Tobias, MD Nationwide Children's Hospital
More Information
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Responsible Party: Joseph D. Tobias, Chairman, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01645098    
Other Study ID Numbers: IRB11-00532
First Posted: July 20, 2012    Key Record Dates
Results First Posted: February 26, 2015
Last Update Posted: February 26, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Dexmedetomidine
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents