Sedation Clinical Trial
Official title:
Pharmacokinetics and Pharmacodynamics of Three Doses of Oral Trans-mucosal Dexmedetomidine for Premedication in Patients Undergoing Modified Radical Mastectomy
Oral trans-mucosal administration is relatively easy and convenient, it also reduces first pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam premedication.
The alpha2-adrenoceptor agonist, dexmedetomidine, was originally developed as a sedative and
analgesic drug for use in intensive care. However, it has a number of unique pharmacodynamic
properties, which also make it useful in anesthesia including; decreased MAC, analgesia
without respiratory depression and a significant reduction in catecholamine secretion. Also
it has been used off-label as an adjunctive agent for sedation and analgesia in patients in
the critical care unit and for sedation during non-invasive procedures in radiology. It also
has a potential role as part of anesthesia care to prevent emergence delirium and
post-anesthesia shivering.
Oral trans-mucosal administration is relatively easy and convenient, it also reduces first
pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam
premedication.
The current literature is focused in studying the sedative and analgesic effects of
intravenously administered dexmedetomidine. Pharmacodynamics and pharmacokinetic studies
undertaken on alternative routes of dexmedetomidine administration are lacking. The
pharmacokinetic properties of trans-mucosal administration of dexmedetomidine have been
demonstrated in one study only, and the clinical effects of non-parenteral administration of
dexmedetomidine have been described in anecdotal case reports.
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