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PI resigned.
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Assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.
Patients identified by selection criteria within 48 hours of intubation will be randomly assigned to one of three study arms: dexmedetomidine 0.2 mcg/kg/hr, dexmedetomidine 0.6 mcg/kg/hr, or placebo. If not already on, patients will be converted to propofol and fentanyl for sedation and analgesia, which will be titrated to a goal SAS score of 3-4.
Patients will be monitored, assessed, and evaluated by all regular policies and procedures of the institution. Extubation will be at the discretion of the physicians and medical team caring for the patient. If the patient is still intubated at five days study drug will then be stopped and further use of dexmedetomidine will be at the discretion of the physicians.
Primary objective will assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.
Secondary objectives include total ventilation time, ICU length of stay, hospital length of stay, patient outcomes/mortality, and total pharmacy expenditures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Low dose dexmedetomidine | Experimental | Dexmedetomidine 0.2 mcg/kg/hr added to fentanyl & propofol. |
|
| 2. High dose dexmedetomidine | Experimental | Dexmedetomidine 0.6 mcg/kg/hr added to fentanyl & propofol. |
|
| 3. Placebo | Placebo Comparator | Placebo added to fentanyl & propofol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total daily dose of fentanyl and propofol | Daily |
| Measure | Description | Time Frame |
|---|---|---|
| Total ventilation time | Study ended | |
| ICU length of stay | Study ended. | |
| Hospital length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John A Kappes, Pharm.D. | Avera McKennan Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Study ended |
| Patient outcomes/mortality | Study ended. |
| Total pharmacy expenditures | Study ended. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |