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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43GM090469-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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This study involves the use of an experimental device which will measure how much propofol is present in your exhaled breath during surgery compared to how much is in your blood. The study results will look at whether the device is as accurate as conventional methods for measuring propofol levels during surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol | Experimental | Subjects will be given Propofol during routine surgery and then using the SMART Device the breath will be captured and compared to blood plasma using High-performance liquid chromatography Analysis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-performance liquid chromatography Analysis | Other | Blood samples will be collected for HPLC analysis to compare with the breath samples. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of propofol concentrations in exhaled breath to those in plasma | Measure and compare propofol concentrations in exhaled breath to those in plasma in human patients anesthetized with propofol. Samples of the exhaled breath from patients will be monitored using the SAW Sensor and collected onto Tenax TA Tubes for analysis by Thermal Desorption GC/MS (using the method described by Grossher et al.) | Sampling will occur every 2 minutes after anesthetic induction up to 10 minutes and then every 5 minutes thereafter up to 1 hour. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donn Dennis, MD | Contact | 352-371-8488 |
| Name | Affiliation | Role |
|---|---|---|
| Donn M Dennis, M.D., F.A.H.A. | Xhale, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32608 | United States |
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| SMART Device | Device | Breath collection for GC-MS analysis to compare with Blood collection. |
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