Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy Clinical Trial

Official title:

Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645098
• Other study ID #: IRB11-00532
• Status: Completed
• Phase: N/A
• First received: June 8, 2012
• Last updated: February 25, 2015
• Start date: August 2011
• Est. completion date: June 2013

Study information

• Verified date: February 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing a muscle biopsy for IRB11-00203.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Intervention

Drug:
• Ketamine
1 mg/kg IV, additional doses of 0.5 mg/kg as needed
• Dexmedetomidine
0.5 mcg/kg/hr IV

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Sedation Score of 3-4	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	No
Secondary	Heart Rate Change After Dexmedetomidine Loading Dose	Difference in heart rate from baseline to immediately following infusion of dexmedetomidine loading dose.	Baseline to immediately post dexmedetomidine infusion.	Yes
Secondary	Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose	Change in MAP from baseline measurement to immediately post dexmedetomidine infusion measured via blood pressure cuff.	Baseline to immediately post dexmedetomidine infusion.	Yes
Secondary	Oxygen Saturation Change After Dexmedetomidine Loading Dose	Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion.	Baseline to immediately post dexmedetomidine infusion.	Yes
Secondary	EtCO2 Change After Dexmedetomidine Loading Dose	Change in end-tidal carbon dioxide from baseline measurement to immediately post dexmedetomidine infusion.	Baseline to immediately post dexmedetomidine infusion.	Yes