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| ID | Type | Description | Link |
|---|---|---|---|
| K23RR021874-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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The purpose of this study is to determine whether sedation affects saccadic eye movements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propofol | Active Comparator | active drug |
|
| dexmedetomidine | Active Comparator | sedative |
|
| midazolam | Active Comparator | Sedative |
|
| placebo | Placebo Comparator | placebo control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Drug | sedative |
| |
| dexmedetomidine |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic Eye Movement Measures | Change in Eye Movements Parameters | baseline to Sedation State (approx. 1 hr) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Clinical Research Center | Birmingham | Alabama | 35294 | United States |
A physical examination of each participant was used to assess their success in the study. Participants were excluded if they did not meat the BMI weight requirement and/or wanted to be excluded from the study.
Recruitment was held at the Clinical Research Unit in Jefferson Towers. There were 65 participants recruited between March 28, 2008 and September 24, 2008. All participants signed a written informed consent and was verified to all the information pertaining to their participation in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine | Sedative Drug 1 |
| FG001 | Midazolam | Sedative Drug 2 |
| FG002 | Placebo | Placebo Control |
| FG003 | Propofol | Sedative Drug 3 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine | sedative dexmedetomidine : Sedative |
| BG001 | Midazolam | Sedative Midazolam : sedative |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Dynamic Eye Movement Measures | Change in Eye Movements Parameters | Posted | Mean | 95% Confidence Interval | (degrees/second) | baseline to Sedation State (approx. 1 hr) |
|
The observation of adverse events will occur from the beginning of sedation monitoring up to discharge (1-4 hrs)
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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 | sedative dexmedetomidine : Sedative |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Froelich | University of Alabama at Birmingham | 205-934-4711 | froelich@uab.edu |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
Sedative |
|
| Midazolam | Drug | sedative |
|
| saline placebo | Drug | saline placebo |
|
| BG002 |
| Placebo |
placebo control saline placebo : saline placebo |
| BG003 | Propofol | active drug propofol : sedative |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 |
| Placebo |
placebo |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Midazolam | Sedative Midazolam : sedative | 0 | 15 | 0 | 15 |
| EG002 | Placebo | placebo control saline placebo : saline placebo | 0 | 15 | 0 | 15 |
| EG003 | Propofol | active drug propofol : sedative | 0 | 20 | 0 | 20 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |