Delirium Clinical Trial
Official title:
Impact of Dexmedetomidine on the Incidence of Postoperative Delirium in Patients After Cardiac Surgery: a Randomized, Double-blinded, and Placebo-controlled Clinical Trial
Postoperative delirium (POD) is a frequently occurring complication after cardiac surgery. Its occurrence is associated with worse outcomes of patients, including increased morbidity, prolonged hospital stay, increased medical cost, and higher mortality. It is also associated with long-term cognitive decline and decreased quality of life. However, until recently, pharmacological interventions that can effectively prevent its occurrence are still limited. The purpose of this study is to investigate whether perioperative dexmedetomidine use can decrease the incidence of postoperative delirium in patients undergoing cardiac surgery.
Delirium is a state of global cerebral dysfunction manifested by acute disturbance of
consciousness, attention, cognition and perception. It develops over a short period of time
(usually hours to days) and tends to fluctuate during the course of the day. The reported
incidences of delirium after cardiac surgery varied from 21% to 47%. The occurrence of
postoperative delirium has significant harmful effects on patients' outcomes, including
increased morbidity, prolonged hospital stay, increased medical cost, and higher mortality.
Its occurrence is also associated with long-term cognitive decline and decreased quality of
life.
The exact pathogenesis that lead to the occurrence of POD are still unclear, and possibly
involves mechanisms such as inflammation, pain and sleep deprivation after surgery.
Furthermore, it has been shown that anesthesia management might also have exerted some
effects. Studies found that avoidance of unnecessary deep anesthesia (under the guidance of
Bispectral Index monitoring) decreases the incidence of POD. Theoretically, measures that
decreases the requirement of anesthetics while maintaining adequate depth of anesthesia and
those that alleviates inflammation and improves postoperative analgesia as well as sleep
quality will decrease the incidence of POD.
Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonists that provides
anxiolysis, sedation and modest analgesia with minimal respiratory depression. Studies showed
that, when used as an adjunctive anesthetics, dexmedetomidine significantly decreases the
requirement of opioid analgesics and other sedatives during anesthesia. A recent study of our
group found that continuous infusion of low-dose dexmedetomidine (0.2 ug/kg/h) during the
first night after surgery significantly improved subjective sleep quality. Two randomized
controlled trials found that, when compared with traditional sedatives (midazolam and
propofol) and analgesics (such as morphine), use of dexmedetomidine in patients after cardiac
surgery is associated with decreased risk of delirium. However, questions still exist as to
whether dexmedetomidine prevent delirium or just does not increase its occurrence since
traditional sedatives/analgesics themselves increases the risk of delirium. Furthermore,
animal experiments showed that dexmedetomidine inhibits the degree of inflammation induced by
endotoxins.
The investigators hypothesize that use of dexmedetomidine as an adjunctive agent during the
perioperative period can decrease the incidence of postoperative delirium in patients
undergoing cardiac surgery, possibly by decreasing the requirement of anesthetics during
surgery, by ameliorating analgesia as well as sleep quality after surgery, and by alleviating
the degree of perioperative inflammatory response.
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