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| Sponsor: | Johns Hopkins University |
|---|---|
| Information provided by: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00390871 |
Purpose
Dexmedetomidine (Precedex, Hospira) is a "super" selective alpha2-agonist - 8-10x more avid binding to alpha2 receptors than clonidine - and may have particularly favorable characteristics as a continuous i.v. infusion sedative for critically ill neuroscience patients. Its combination of anxiolysis, analgesia, without undue lethargy may make it an ideal agent where frequent neurological examinations are important (12). Unclear, however, is whether Precedex is superior to current common i.v. sedation protocols, and if there are any undue concerns of this agent on cerebral physiology and cortical stimulation.
| Condition | Intervention | Phase |
|---|---|---|
|
Sedation |
Drug: Precedex Drug: Propofol |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Acute Neurological ICU Sedation Trial (ANIST) |
| Enrollment: | 60 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Study 1: Inclusion Criteria:
Neuroscience patients in the NCCU who are:
Study 1: Exclusion Criteria:
Study 2: Inclusion Criteria:
Critically ill neuroscience patients who are:
Study 2: Exclusion Criteria:
Study 3: Inclusion Criteria:
Critically ill neuroscience patients who are:
Study 3: Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287 | |
| Principal Investigator: | Marek Mirski, MD, PhD | Johns Hopkins University |
More Information
| ClinicalTrials.gov Identifier: | NCT00390871 History of Changes |
| Other Study ID Numbers: | ANIST |
| Study First Received: | October 19, 2006 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
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Patient Must be Under |
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Propofol Dexmedetomidine Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |