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: June 25, 2013
Last verified: June 2013
  Purpose

This is an observational 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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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:
  • Level of sedation [ Time Frame: Immediately prior to incision ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate [ Time Frame: On induction; immediately prior to incision; every minute during muscle biospsy, an expected average of 30 minutes ] [ Designated as safety issue: Yes ]
  • Blood pressure [ Time Frame: On induction; immediately prior to incision; every 3 minutes during muscle biopsy, an expected average of 30 minutes ] [ Designated as safety issue: Yes ]
  • Oxygen saturation [ Time Frame: On induction; immediately prior to incision; every minute during muscle biospsy, an expected average of 30 minutes ] [ Designated as safety issue: Yes ]
  • EtCO2 [ Time Frame: On induction; immediately prior to incision; every minute during muscle biospsy, an expected average of 30 minutes ] [ Designated as safety issue: Yes ]
    End-tidal carbon dioxide


Enrollment: 19
Study Start Date: August 2011
Study Completion Date: June 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Last Updated: June 25, 2013
Health Authority: United States: Institutional Review Board

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
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on September 18, 2014