Haloperidol prophylaxis does not prevent postoperative delirium in elderly patients: a randomized, open-label prospective trial

Postoperative delirium is the most common postoperative complication in the elderly. The purpose of this study was to evaluate the safety and effectiveness of the preventive administration of low-dose haloperidol on the development of postoperative delirium after abdominal or orthopedic surgery in elderly patients. A total of 119 patients aged 75 years or older who underwent elective surgery for digestive or orthopedic disease were included in this study. Patients were divided into those who did (intervention group, n = 59) and did not (control group, n = 60) receive 2.5 mg of haloperidol at 18:00 daily for 3 days after surgery; a randomized, open-label prospective study was performed on these groups. The primary endpoint was the incidence of postoperative delirium during the first 7 days after the operation. The incidence of postoperative delirium in all patients was 37.8 %. No side effects involving haloperidol were noted; however, the incidences of postoperative delirium were 42.4 and 33.3 % in the intervention and control groups, respectively, which were not significantly different (p = 0.309). No significant effect of the treatment was observed on the severity or persistence of postoperative delirium. The preventive administration of low-dose haloperidol did not induce any adverse events, but also did not significantly decrease the incidence or severity of postoperative delirium or shorten its persistence.