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| Name | Class |
|---|---|
| American Society of Regional Anesthesia | OTHER |
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The investigators propose to evaluate the potential effect of sedation on pain perception in two ways, by asking for a participant's pain rating(subjective) and by evaluating a subject's brain activation using fMRI(objective).
We propose to contrast and compare the effect of propofol and midazolam, two GABA-related sedative drugs, and dexmedetomidine, an alpha-2 adrenergic agonist, on pain perception in human volunteers by asking a participant to rate their pain and by evaluating a subject's brain activation using fMRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol | Active Comparator | Administration via an IV |
|
| Midazolam | Active Comparator | Administration via an IV |
|
| Dexmedetomidine | Active Comparator | Administration via an IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine | Drug |
| ||
| midazolam |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Rating Change | Mechanical Slide Algometer (www.decisionaidsonline.com), Range: "No Pain Sensation" (1) to " Most Intense Sensation Imaginable" (10) 10 point scale. Change Time Points: Baseline (no sedation), Sedation. Same Day Intervention. | Sedation |
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Inclusion Criteria:
Healthy subjects
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A Froelich, M.D. | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23314164 | Result | Frolich MA, Zhang K, Ness TJ. Effect of sedation on pain perception. Anesthesiology. 2013 Mar;118(3):611-21. doi: 10.1097/ALN.0b013e318281592d. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine | Sedation Arm 1, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale. |
| FG001 | Midazolam | Sedation Arm 2, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale. |
| FG002 | Propofol | Sedation Arm 3, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine | |
| BG001 | Midazolam | |
| BG002 | Propofol |
| 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 | Pain Rating Change | Mechanical Slide Algometer (www.decisionaidsonline.com), Range: "No Pain Sensation" (1) to " Most Intense Sensation Imaginable" (10) 10 point scale. Change Time Points: Baseline (no sedation), Sedation. Same Day Intervention. | Posted | Least Squares Mean | Standard Error | units on a scale | Sedation |
|
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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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Froelich | University of Alabama at Birmigham | (205)975-0145 | froelich@uab.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| propofol | Drug |
|
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Midazolam | 0 | 27 | 0 | 27 |
| EG002 | Propofol | 0 | 31 | 0 | 31 |
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| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |