Shinji Fukata1,2, Yasuji Kawabata3, Ken Fujishiro3, Yuichi Kitagawa3, Kojiro Kuroiwa4, Hirotoshi Akiyama5, Marie Takemura6, Masahiko Ando7, Hideyuki Hattori8. 1. Department of Surgery, National Center for Geriatrics and Gerontology, 7-430 Morioka, Obu, Aichi, 474-8511, Japan. fukatash@ncgg.go.jp. 2. Department of Perioperative Medical Care, National Center Hospital for Geriatrics and Gerontology, 7-430, Morioka, Obu, Aichi, 474-8511, Japan. fukatash@ncgg.go.jp. 3. Department of Surgery, National Center for Geriatrics and Gerontology, 7-430 Morioka, Obu, Aichi, 474-8511, Japan. 4. Department of Surgery, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, 35-2 Sakaecho, Itabasi-ku, Tokyo, 173-0015, Japan. 5. Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan. 6. Department of Orthopedics, National Center for Geriatrics and Gerontology, 7-430, Morioka, Obu, Aichi, 474-8511, Japan. 7. Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, 65 Turumai, Shouwa-ku, Nagoya, 466-8560, Japan. 8. Department of Psychiatry, National Center for Geriatrics and Gerontology, 7-430, Morioka, Obu, Aichi, 474-8511, Japan.
Abstract
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.
RCT Entities:
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.
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