Mechanically Ventilated and Intubated Subjects Clinical Trial
Official title:
A Phase 4, Randomized, Double-Blind, Multi-Center, Comparator Study Evaluating the Safety and Efficacy of Dexmedetomidine Compared to IV Midazolam in ICU Subjects Requiring Greater Than Twenty-Four Hours of Continuous Sedation
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU subjects who are initially intubated, mechanically ventilated and require sedation for beyond 24 hours.
Traditional agents such benzodiazepines and propofol have long been used to sedate
critically ill patients. Unfortunately, these agents have serious disadvantages that may
have a negative impact on patient outcomes. These disadvantages include respiratory
depression, prolonged mechanical ventilation, paradoxical agitation, myocardial depression,
hypotension, tachyphylaxis, physical dependence, and an unpredictable duration of action
following long term infusions. Additionally, concomitant use of an opioid or other analgesic
is often required for ICU patients to achieve adequate levels of pain relief, which may also
prolong awakening and possibly increase respiratory depression.
Dexmedetomidine may offer a new treatment option that remedies many of the deficiencies of
traditional sedatives. This agent would provide for accurate, titratable sedation and
analgesia without the concurrent respiratory depression and accumulation common to other
agents. It may permit greater patient interaction due to reduced impairment of cognition and
may reduce risks associated with opioids due to its analgesia sparing property. Although
such a drug may have important benefits for ICU patients requiring sedation for greater than
24 hours, dexmedetomidine is not currently approved for such long-term usage.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment