Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

Not Applicable

Completed

• Conditions: Duchenne Muscular Dystrophy
• Interventions: Drug: Ketamine; Drug: Dexmedetomidine

• Registration Number: NCT01645098
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

This is an interventional study on Duchenne muscular dystrophy patients who will be receiving sedation for a muscle biopsy as part of another study.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-20
• Primary Completion: 2013-04
• Study Completion: 2013-06
• Status Verified: 2015-02
• Results First Submitted: 2015-02-04
• Results First Submitted QC: 2015-02-25
• Last Update Submitted: 2015-02-25
• Results First Posted: 2015-02-26
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 53

Inclusion Criteria

• Patients undergoing a muscle biopsy for IRB11-00203.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine 1 mcg/kg	Dexmedetomidine	Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.
Dexmedetomidine 1 mcg/kg	Ketamine	Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.
Dexmedetomidine 0.5 mcg/kg	Ketamine	Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.
Dexmedetomidine 0.5 mcg/kg	Dexmedetomidine	Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.

Primary Outcome Measures

Name	Time	Method
Time to Sedation Score of 3-4	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

Name	Time	Method
Heart Rate Change After Dexmedetomidine Loading Dose	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	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	Baseline to immediately post dexmedetomidine infusion.	Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion.
EtCO2 Change After Dexmedetomidine Loading Dose	Baseline to immediately post dexmedetomidine infusion.	Change in end-tidal carbon dioxide from baseline measurement to immediately post dexmedetomidine infusion.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States