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


CONCLUSIONS
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.
Department of Surgery, National Center for Geriatrics and Gerontology, 7-430 Morioka, Obu, Aichi, 474-8511, Japan. fukatash@ncgg.go.jp.|Department of Perioperative Medical Care, National Center Hospital for Geriatrics and Gerontology, 7-430, Morioka, Obu, Aichi, 474-8511, Japan. fukatash@ncgg.go.jp.
Shinji
S
Fukata
Department of Surgery, National Center for Geriatrics and Gerontology, 7-430 Morioka, Obu, Aichi, 474-8511, Japan.
Yasuji
Y
Kawabata
Department of Surgery, National Center for Geriatrics and Gerontology, 7-430 Morioka, Obu, Aichi, 474-8511, Japan.
Ken
K
Fujishiro
Department of Surgery, National Center for Geriatrics and Gerontology, 7-430 Morioka, Obu, Aichi, 474-8511, Japan.
Yuichi
Y
Kitagawa
Department of Surgery, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, 35-2 Sakaecho, Itabasi-ku, Tokyo, 173-0015, Japan.
Kojiro
K
Kuroiwa
Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
Hirotoshi
H
Akiyama
Department of Orthopedics, National Center for Geriatrics and Gerontology, 7-430, Morioka, Obu, Aichi, 474-8511, Japan.
Marie
M
Takemura
Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, 65 Turumai, Shouwa-ku, Nagoya, 466-8560, Japan.
Masahiko
M
Ando
Department of Psychiatry, National Center for Geriatrics and Gerontology, 7-430, Morioka, Obu, Aichi, 474-8511, Japan.
Hideyuki
H
Hattori
D000368:Aged; D000369:Aged, 80 and over; D014150:Antipsychotic Agents / Q000008:administration & dosage*; D003693:Delirium / Q000453:epidemiology / Q000517:prevention & control*; D017558:Elective Surgical Procedures; D005260:Female; D006220:Haloperidol / Q000008:administration & dosage*; D006801:Humans; D015994:Incidence; D008297:Male; D011182:Postoperative Care; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D011184:Postoperative Period; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D006220:Haloperidol
Elderly patients; Haloperidol prophylaxis; NEECHAM; Open-label prospective trial; Postoperative delirium; Randomized