Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

February 25, 2015 updated by: Joseph D. Tobias, Nationwide Children's Hospital
This is an interventional study on Duchenne muscular dystrophy patients who will be receiving sedation for a muscle biopsy as part of another study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients undergoing a muscle biopsy for IRB11-00203.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately prior to incision

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to immediately post dexmedetomidine infusion.
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.
Baseline to immediately post dexmedetomidine infusion.
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.
Baseline 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.
Baseline to immediately post dexmedetomidine infusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

June 8, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (ESTIMATE)

July 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 26, 2015

Last Update Submitted That Met QC Criteria

February 25, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB11-00532

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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