Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

NCT ID: NCT01645098

Last Updated: 2015-02-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Duchenne Muscular Dystrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexmedetomidine 1 mcg/kg

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

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine

Intervention Type DRUG

0.5 mcg/kg/hr IV

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.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine

Intervention Type DRUG

0.5 mcg/kg/hr IV

Interventions

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Ketamine

1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Intervention Type DRUG

Dexmedetomidine

0.5 mcg/kg/hr IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing a muscle biopsy for IRB11-00203.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joseph D. Tobias

Chairman, Dept. of Anesthesiology & Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph D Tobias, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB11-00532

Identifier Type: -

Identifier Source: org_study_id

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