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Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01645098
First Posted: July 20, 2012
Last Update Posted: February 26, 2015
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.
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
  Purpose
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 Intervention
Duchenne Muscular Dystrophy Drug: Ketamine Drug: Dexmedetomidine

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Joseph D. Tobias, Nationwide Children's Hospital:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 53
Study Start Date: August 2011
Study Completion Date: June 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients undergoing a muscle biopsy for IRB11-00203.
  Contacts and Locations
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
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Joseph D Tobias, MD Nationwide Children's Hospital
  More Information

Responsible Party: Joseph D. Tobias, Chairman, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01645098     History of Changes
Other Study ID Numbers: IRB11-00532
First Submitted: June 8, 2012
First Posted: July 20, 2012
Results First Submitted: February 4, 2015
Results First Posted: February 26, 2015
Last Update Posted: February 26, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
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