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

Abstract

Purpose: 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. Subjects: A total of 119 patients aged 75 years or older who underwent elective surgery for digestive or orthopedic disease were included in this study. Methods: 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. Results: 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. Conclusions: 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.