Elderly Clinical Trial
Official title:
Effects of Two Different Anesthesia-analgesia Methods on the Incidence of Postoperative Delirium: a Multicenter, Randomized Controlled Trial
Postoperative delirium is a common complication in elderly patients after surgery. Its occurrence is associated with worse outcomes. The pathophysiology of delirium remains poorly understood. However, an universal phenomenon is that delirium frequently occurs in elderly patients after major complicated surgery, but is rarely seen after minor ambulatory surgery (such as cataract surgery). This indicates that stress response produced by surgery might have an important role in the pathogenesis of delirium. It has been reported that, when compared with general anesthesia and postoperative intravenous analgesia, neuraxial anesthesia and analgesia reduced the occurrence of postoperative complications and mortality in high risk patients. Combined epidural-general anesthesia is frequently used in clinical practice. This anesthetic method provides advantages of both epidural and general anesthesia, i.e. it blocks the afferent pathway of nociceptive stimulus by neuraxial blockade during and after surgery, and allows patients to endure long-duration surgery without any awareness. The investigators hypothesize that combined epidural-general anesthesia and postoperative epidural analgesia can decrease the incidence of delirium in elderly patients after major surgery when compared with general anesthesia alone and postoperative intravenous analgesia.
Delirium is an acutely occurred and transient mental syndrome characterized by global
impairment of cognitive functions, reduced level of consciousness, abnormalities of
attention, increased or decreased psychomotor activity, and disordered sleep-wake cycle.
Postoperative delirium is a common complication in elderly patients after surgery. Dyer et al
reviewed 80 primary studies and found that the mean incidence of postoperative delirium is
about 36.8% (range 0%-73.5%) after surgery. It occurs in up to 80% of patients in the
intensive care unit (ICU). Our recent studies found that delirium occurred in 51.0% of
patients after cardiac surgery and in 44.5% of patients after non-cardiac surgery.
The occurrence of postoperative delirium is associated with worse outcomes. Studies showed
that delirious patients have prolonged ICU stay, increased incidence of complications,
prolonged hospitalization, high mortality rate, and increased health care costs. Delirium is
also associated with increased risk of long-term cognitive decline and poor quality of life.
A recent follow-up study (mean follow-up time 27.9 ± 3.1 months) by our research group found
that, after adjusting factors such as age, occurrence of postoperative complications, and
stage of cancer, etc, the occurrence of postoperative delirium still remained an independent
predictor of long-term mortality.
The pathophysiology of delirium remains poorly understood. An universal phenomenon is that
delirium frequently occurs in elderly patients after major complicated surgery, but is rarely
seen after minor ambulatory surgery (such as cataract surgery). Studies also found that
postoperative pain is an independent risk factor of delirium, whereas effective pain relief
may help to reduce the incidence of delirium. Our recent studies showed that high serum
cortisol level is an independent risk factor of postoperative delirium. In addition,
inflammatory response may also contribute to the pathogenesis of delirium. Trauma, pain,
cortisol secretion and inflammation are all important components of surgical stress response.
The above results indicated that stress response produced by surgery might have an important
role in the pathogenesis of delirium.
Previous studies demonstrated that, when compared with general anesthesia, neuraxial
anesthesia attenuates the hypersecretion of cortisol, and decreases the intensity of
inflammatory response more effectively after surgery. And epidural analgesia provides better
postoperative pain relief than intravenous analgesia. It was also reported that, when
compared with general anesthesia and intravenous analgesia, neuraxial anesthesia and
analgesia reduces the occurrence of postoperative complications and mortality in high risk
patients. Combined epidural-general anesthesia is frequently used in clinical practice, and
is performed in about 1/4 of patients undergoing surgery in the applicant's hospital.
Theoretically, this anesthetic method provides advantages of both epidural and general
anesthesia, i.e. it blocks the afferent pathway of nociceptive stimulus by neuraxial blockade
during and after surgery, and allow patients to endure long-duration complicated surgeries
without any awareness. However, there is no evidence whether combined epidural-general
anesthesia/postoperative epidural analgesia can decrease the incidence of postoperative
delirium in elderly patients undergoing major surgery.
The objective of the study is to compare the effects of combined epidural-general
anesthesia/postoperative epidural analgesia and general anesthesia/postoperative intravenous
analgesia on the incidence of postoperative delirium in elderly patients undergoing major
noncardiac surgery.
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