采用氟哌啶醇预防可降低老年人在非心脏手术后的谵妄发生率：随机对照试验

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 65yrs or older who were admitted to the intensive care unit after noncardiac surgery.

Intervention:

Haloperidol (0.5mg intravenous bolus injection followed by continuous infusion at a rate of 0.1mg/h for 12hrs; 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 7days 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 7days 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 (6.2days [95% confidence interval 5.9–6.4] vs. 5.7days [95% confidence interval 5.4–6.0]; p=.021; and 6.8±0.5days vs. 6.7±0.8days; p=.027, respectively), whereas the median length of intensive care unit stay was significantly shorter (21.3hrs [95% confidence interval 20.3–22.2] vs. 23.0hrs [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