Haloperidol prophylaxis for preventing aggravation of postoperative delirium in elderly patients: a randomized, open-label prospective trial

Purposes The aim of this study was to evaluate the safety and efficacy of the early administration haloperidol in preventing the aggravation of postoperative delirium in elderly patients. Methods A total of 201 patients (age ≥75 years) who underwent elective surgery were enrolled. The patients were divided into two groups: the intervention group ( n = 101) received prophylactic haloperidol (5 mg); the control group ( n = 100) did not. Haloperidol was administered daily during postoperative days 0–5 to the patients who presented with NEECHAM scores of 20–24 when measured at 18:00. The primary endpoint was the incidence of severe postoperative delirium. Results The incidence of severe postoperative delirium in all patients was 25.1%. The incidence of severe postoperative delirium in the intervention group (18.2%) was significantly lower than that in the control group (32.0%) ( p = 0.02). The difference between the two groups was larger when the analysis was limited to the 70 patients who had NEECHAM scores of 20–24 for at least one day during postoperative days 0–5. No adverse effects of the haloperidol were observed. Conclusion The prophylactic administration of haloperidol at the early stage of delirium significantly reduced the incidence of severe postoperative delirium in elderly patients. Clinical Trial Registration UMIN000007204.