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| Sponsored by: |
Duke University |
|---|---|
| Information provided by: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00538616 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Injury Intracranial Pressure |
Drug: precedex |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Dose Comparison, Crossover Assignment, Pharmacokinetics Study |
| Official Title: | A Phase IV Single Center Cross Over Clinical Study Comparing Two Different Sedations Strategies for Mechanically Ventilated Patients With Neurological Critical Illness |
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
precedex: Experimental
subjects will receive precedex infusion for 6-hours
|
Drug: precedex
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
|
|
propofol: Active Comparator
Subjects will receive propofol infusion for 6-hours
|
Drug: precedex
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Carmelo Graffagnino, MD 919-668-5546 Graff002@mc.duke.edu | |
| Principal Investigator: | Carmelo Graffagnino, MD | Duke University |
| Principal Investigator: | DaiWai M Olson, PhD RN | Duke University |
More Information
| Responsible Party: | Duke ( Carmelo Graffagnino ) |
| Study ID Numbers: | hospira |
| Study First Received: | September 28, 2007 |
| Last Updated: | August 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00538616 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Brain Injury |
|
Craniocerebral Trauma Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Central Nervous System Depressants Trauma, Nervous System Brain Diseases |
Adrenergic Agonists Analgesics, Non-Narcotic Critical Illness Hypnotics and Sedatives Peripheral Nervous System Agents Dexmedetomidine Analgesics Brain Injuries Propofol |
|
Craniocerebral Trauma Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Nervous System Diseases Physiological Effects of Drugs Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Central Nervous System Depressants Trauma, Nervous System |
Brain Diseases Adrenergic Agonists Pharmacologic Actions Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Hypnotics and Sedatives Peripheral Nervous System Agents Analgesics Dexmedetomidine Brain Injuries Central Nervous System Agents |
