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Haloperidol Prophylaxis Decreases Delirium Incidence in Elderly Patients After Noncardiac Surgery: A Randomized Controlled Trial
Haloperidol Prophylaxis Decreases Delirium Incidence in Elderly Patients After Noncardiac Surgery: A Randomized Controlled Trial. Crit Care Med. 2012;40:731-739.
Study Question: Is the short-term use of low dose intravenous haloperidol safe and effective in preventing post-operative delirium in critically ill elderly patients after noncardiac surgery?
Study Description: This prospective, double-blind, placebo controlled, multicenter trial (n=457) randomized patients > 65 years old admitted to the ICU after noncardiac surgery to receive haloperidol 0.5 mg IV bolus followed by continuous infusion of 0.1 mg/hr for 12 hours or placebo. The primary endpoint was incidence of delirium during the first seven days after surgery. Secondary endpoints included time to delirium onset, open-label haloperidol usage, delirium-free days, ICU and hospital length of stay, post-operative complications and 28-day mortality.
Results: Patients in the haloperidol group had significantly longer durations of anesthesia and surgery. The use of fentanyl, midazolam and propofol were similar between groups. In the haloperidol group, incidence of postoperative delirium was significantly lower (15.3 vs 23.2%, p = 0.031) and time to delirium onset was longer (6.2 vs 5.7 d, p = 0.021). Delirium-free days and length of ICU stay were statistically significantly shorter in the haloperidol group (6.8 vs 6.7 d, p = 0.027; 21.3 vs 23 hrs, p = 0.024, respectively), but length of hospital stay and 28-day mortality did not differ. Use of open-label haloperidol, adverse events and postoperative complications were similar between groups.
Conclusions: Prophylactic, low-dose intravenous haloperidol significantly decreases the incidence of post-operative delirium with limited adverse effects in elderly patients admitted to the ICU after noncardiac surgery.
Perspective: While prophylactic haloperidol appears safe and effective in decreasing post-operative delirium, its effect on ICU and hospital length of stay are not clinically significant. Also, 75% of patients were post-operative intra-abdominal surgery which limits generalizeability.