Objectives: To evaluate the efficacy and safety of short-term low-dose intravenous haloperidol for delirium prevention in critically ill elderly patients after noncardiac surgery.
Design: Prospective, randomized, double-blind, and placebo-controlled trial in two centers.
Setting: Intensive care units of two large tertiary teaching hospitals.
Patients: Four hundred fifty-seven patients 65 yrs or older who were admitted to the intensive care unit after noncardiac surgery.
Intervention: Haloperidol (0.5 mg intravenous bolus injection followed by continuous infusion at a rate of 0.1 mg/h for 12 hrs; n = 229) or placebo (n = 228) was randomly administered from intensive care unit admission.
Measures: The primary end point was the incidence of delirium within the first 7 days after surgery. Secondary end points included time to onset of delirium, number of delirium-free days, length of intensive care unit stay, all-cause 28-day mortality, and adverse events. Delirium was assessed using the confusion assessment method for the intensive care unit.
Results: The incidence of delirium during the first 7 days after surgery was 15.3% (35/229) in the haloperidol group and 23.2% (53/228) in the control group (p = .031). The mean time to onset of delirium and the mean number of delirium-free days were significantly longer (6.2 days [95% confidence interval 5.9−6.4] vs. 5.7 days [95% confidence interval 5.4−6.0]; p = .021; and 6.8 ± 0.5 days vs. 6.7 ± 0.8 days; p = .027, respectively), whereas the median length of intensive care unit stay was significantly shorter (21.3 hrs [95% confidence interval 20.3−22.2] vs. 23.0 hrs [95% confidence interval 20.9–25.1]; p = .024) in the haloperidol group than in the control group. There was no significant difference with regard to all-cause 28-day mortality between the two groups (0.9% [2/229] vs. 2.6% [6/228]; p = .175). No drug-related side effects were documented.
Conclusions: For elderly patients admitted to intensive care unit after noncardiac surgery, short-term prophylactic administration of low-dose intravenous haloperidol significantly decreased the incidence of postoperative delirium. The therapy was well-tolerated.
From the Departments of Anesthesiology and Surgical Intensive Care (WW, DXW, SLL, KSC, XEG) and Biostatistics (SNZ), Peking University First Hospital, Beijing, China; Department of Critical Care Medicine (HLL, XZ, GQY), Peking University Third Hospital, Beijing, China.
* See also p. 982.
The first two authors, Wei Wang and Hong-Liang Li, contributed equally to this work.
The authors have not disclosed any potential conflicts of interest.
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