| Background: Dexmedetomidine has been approved for short-term analgesia
and sedation of patients in the intensive care unit (ICU). Longer duration of
sedation with Dexmedetomidine is off-label, and its safety has not yet been
tested. This study aims to examine the safety profile for long-term use of
Dexmedetomidine and compare it to midazolam (MID) based sedation in the
ICU.
Materials and Methods: One hundred and one patients on mechanical
ventilation were randomized to receive either Dexmedetomidine 0.2-1.0
µg/kg/h or MID 20- 40 µg/kg/h in a double-blinded fashion to reach the target
of -2 to 1 on the Richmond Agitation-Sedation Scale (RASS). Duration of
mechanical ventilation was the primary endpoint; secondary endpoints
included the occurrences of composite cardiac adverse event (CCAE),
bradycardia, hypotension, significant dysrhythmias, heart failure myocardial
infarction or death within 28 days, ICU length of stay, need for additive
analgesic, time spent at target sedation, and delirium.
Results: The duration of mechanical ventilation and ICU stay were almost
two days shorter in the Dexmedetomidine group (P= 0.002 and 0.001,
respectively), but regarding CCAE, sinus bradycardia occurred more
frequently (P= 0.399), and mortality was similar in both groups (P=0.378).
Conclusion: Our results confirmed the results of previous trials showing that
long-term Dexmedetomidine was comparable to benzodiazepines for the
frequency of major complications in critically ill patients. Physicians should
weigh these benefits against the occurrence of significant bradycardia and
hypotension. |