Text Size

Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01645098
First received: June 8, 2012
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  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:

U.S. FDA Resources

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


Estimated Enrollment: 25
Study Start Date: August 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (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
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: July 19, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013