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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine 1 mcg/kg | Experimental | 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 | Experimental | Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | 1 mg/kg IV, additional doses of 0.5 mg/kg as needed |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph D Tobias, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine 1 mcg/kg | Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr. Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed Dexmedetomidine: 0.5 mcg/kg/hr IV |
| FG001 | 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. Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed Dexmedetomidine: 0.5 mcg/kg/hr IV |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine 1 mcg/kg | Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr. Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed Dexmedetomidine: 0.5 mcg/kg/hr IV |
| BG001 | Dexmedetomidine 0.5 mcg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | minutes | Immediately prior to incision |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexmedetomidine 1 mcg/kg | Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr. Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed Dexmedetomidine: 0.5 mcg/kg/hr IV |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marco Corridore, MD | Nationwide Children's Hospital | 614-722-4200 | Marco.Corridore@nationwidechildrens.org |
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| ID | Term |
|---|---|
| D020388 | Muscular Dystrophy, Duchenne |
| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Dexmedetomidine | Drug | 0.5 mcg/kg/hr IV |
|
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 | Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion. | Baseline to immediately post dexmedetomidine infusion. |
| 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. |
Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr. Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed Dexmedetomidine: 0.5 mcg/kg/hr IV |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
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| Secondary | Heart Rate Change After Dexmedetomidine Loading Dose | Difference in heart rate from baseline to immediately following infusion of dexmedetomidine loading dose. | Posted | Mean | Standard Deviation | BPM | Baseline to immediately post dexmedetomidine infusion. |
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|
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| 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. | Posted | Mean | Standard Deviation | mmHg | Baseline to immediately post dexmedetomidine infusion. |
|
|
|
| Secondary | Oxygen Saturation Change After Dexmedetomidine Loading Dose | Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion. | Posted | Mean | Standard Deviation | percentage of oxygen | Baseline to immediately post dexmedetomidine infusion. |
|
|
|
| Secondary | EtCO2 Change After Dexmedetomidine Loading Dose | Change in end-tidal carbon dioxide from baseline measurement to immediately post dexmedetomidine infusion. | Posted | Mean | Standard Deviation | mmHg | Baseline to immediately post dexmedetomidine infusion. |
|
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|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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. Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed Dexmedetomidine: 0.5 mcg/kg/hr IV | 0 | 29 | 0 | 29 |
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| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |