Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01645098
First received: June 8, 2012
Last updated: February 25, 2015
Last verified: February 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 Nationwide Children's Hospital:

Primary Outcome Measures:
  • Time to Sedation Score of 3-4 [ Time Frame: Immediately prior to incision ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing a muscle biopsy for IRB11-00203.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 8, 2012
Results First Received: February 4, 2015
Last Updated: February 25, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Muscular Diseases
Muscular Disorders, Atrophic
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 29, 2015