Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

Nationwide Children's Hospital

Status: Completed

Conditions: Duchenne Muscular Dystrophy

Treatments: Drug: Ketamine; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01645098

IRB11-00532

Details and patient eligibility

About

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

Enrollment: 53 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients undergoing a muscle biopsy for IRB11-00203.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Dexmedetomidine 1 mcg/kg

Experimental group

Description:

Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.

Treatment:

Drug: Dexmedetomidine

Drug: Ketamine

Dexmedetomidine 0.5 mcg/kg

Experimental group

Description:

Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.

Treatment:

Drug: Dexmedetomidine

Drug: Ketamine