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| Name | Class |
|---|---|
| Hospira, now a wholly owned subsidiary of Pfizer | INDUSTRY |
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The purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam.
The hypothesis is that a neurologic exam performed when the subject has continuous infusion of precedex will result in less brain injury (where the lactate/pyruvate ratio indicates injury) then when a neurologic exam is performed on subjects receiving propofol, because that exam requires that the propofol infusion be stopped.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precedex-Propofol | Active Comparator | Patients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours. |
|
| Propofol- Precedex | Active Comparator | Patients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lactate/Pyruvate (L/P)Ratio | L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmelo Graffagnino, MD | Duke University | Principal Investigator |
| DaiWai M Olson, PhD RN | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
Study started at onset of shift with 1 hour washout between crossover. One subject taken off sedation prior to enrollment because they were no longer eligible
Subjects approached if they had indwelling Licox catheters and were given sedation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Precedex-Propofol | Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours. |
| FG001 | Propofol- Precedex | Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Precedex-Propofol | Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours. |
| BG001 | Propofol- Precedex |
| 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 | Lactate/Pyruvate (L/P)Ratio | L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial. | Posted | Mean | Standard Deviation | ratio | 1 hour |
|
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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 | Precedex-Propofol | Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death to initial stroke | Nervous system disorders | Systematic Assessment | Death was not unexpected in this case prior to subject enrollment due to severity of illness on presentation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Systematic Assessment | Minor bradycardia Heart Rate (HR)<60 that did not require intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carmelo Graffagnino | Duke University | 919/681-3751 | Carmelo.Graffagnino@duke.edu |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Propofol | Drug | in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover) |
|
|
Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
| BG002 | 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 |
|
|
|
| 1 |
| 5 |
| 2 |
| 5 |
| EG001 | Propofol- Precedex | Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours. | 0 | 3 | 0 | 3 |
|
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment | Onset of anemia prior to enrollment |
|
| penumonia | Infections and infestations | Systematic Assessment | Secondary to endotracheal intubation |
|
| Pulmonary embolus | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Found on 3/7/2008 Study ended on 2/23/2008 |
|
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |