Volume 53, Issue 10 p. 1658-1666

Haloperidol Prophylaxis for Elderly Hip-Surgery Patients at Risk for Delirium: A Randomized Placebo-Controlled Study

Kees J. Kalisvaart MD

Kees J. Kalisvaart MD

From the * Departments of Geriatric Medicine and Orthopedic Surgery, Medical Center Alkmaar, Alkmaar, the Netherlands Department of Pharmacy, Reinier de Graaf Group, Delft, the Netherlands Department of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the NetherlandsDepartments of § Psychiatry Neurology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands Free University of Amsterdam, Amsterdam, the Netherlands.

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Jos F. M. De Jonghe PhD

Jos F. M. De Jonghe PhD

From the * Departments of Geriatric Medicine and Orthopedic Surgery, Medical Center Alkmaar, Alkmaar, the Netherlands Department of Pharmacy, Reinier de Graaf Group, Delft, the Netherlands Department of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the NetherlandsDepartments of § Psychiatry Neurology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands Free University of Amsterdam, Amsterdam, the Netherlands.

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Marja J. Bogaards PharmD

Marja J. Bogaards PharmD

From the * Departments of Geriatric Medicine and Orthopedic Surgery, Medical Center Alkmaar, Alkmaar, the Netherlands Department of Pharmacy, Reinier de Graaf Group, Delft, the Netherlands Department of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the NetherlandsDepartments of § Psychiatry Neurology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands Free University of Amsterdam, Amsterdam, the Netherlands.

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Ralph Vreeswijk RN, MSc

Ralph Vreeswijk RN, MSc

From the * Departments of Geriatric Medicine and Orthopedic Surgery, Medical Center Alkmaar, Alkmaar, the Netherlands Department of Pharmacy, Reinier de Graaf Group, Delft, the Netherlands Department of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the NetherlandsDepartments of § Psychiatry Neurology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands Free University of Amsterdam, Amsterdam, the Netherlands.

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Toine C. G. Egberts PhD

Toine C. G. Egberts PhD

From the * Departments of Geriatric Medicine and Orthopedic Surgery, Medical Center Alkmaar, Alkmaar, the Netherlands Department of Pharmacy, Reinier de Graaf Group, Delft, the Netherlands Department of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the NetherlandsDepartments of § Psychiatry Neurology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands Free University of Amsterdam, Amsterdam, the Netherlands.

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Bart J. Burger MD, PhD

Bart J. Burger MD, PhD

From the * Departments of Geriatric Medicine and Orthopedic Surgery, Medical Center Alkmaar, Alkmaar, the Netherlands Department of Pharmacy, Reinier de Graaf Group, Delft, the Netherlands Department of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the NetherlandsDepartments of § Psychiatry Neurology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands Free University of Amsterdam, Amsterdam, the Netherlands.

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Piet Eikelenboom MD, PhD

Piet Eikelenboom MD, PhD

From the * Departments of Geriatric Medicine and Orthopedic Surgery, Medical Center Alkmaar, Alkmaar, the Netherlands Department of Pharmacy, Reinier de Graaf Group, Delft, the Netherlands Department of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the NetherlandsDepartments of § Psychiatry Neurology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands Free University of Amsterdam, Amsterdam, the Netherlands.

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Willem A. Van Gool MD, PhD

Willem A. Van Gool MD, PhD

From the * Departments of Geriatric Medicine and Orthopedic Surgery, Medical Center Alkmaar, Alkmaar, the Netherlands Department of Pharmacy, Reinier de Graaf Group, Delft, the Netherlands Department of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the NetherlandsDepartments of § Psychiatry Neurology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands Free University of Amsterdam, Amsterdam, the Netherlands.

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First published: 21 September 2005
Citations: 485
Address correspondence to K. J. Kalisvaart, MD, Medical Center Alkmaar, PO Box 501, 1800 AM Alkmaar, the Netherlands. E-mail: [email protected]

A paper with the preliminary results was accepted for presentation at the meeting of the American Geriatrics Society in Baltimore, Maryland, 2003. Because of illness, no presentation was made. Abstract was published in the Journal of the American Geriatrics Society, May 2003.

Abstract

Objectives: To study the effectiveness of haloperidol prophylaxis on incidence, severity, and duration of postoperative delirium in elderly hip-surgery patients at risk for delirium.

Design: Randomized, double-blind, placebo-controlled trial.

Setting: Large medical school–affiliated general hospital in Alkmaar, the Netherlands.

Participants: A total of 430 hip-surgery patients aged 70 and older at risk for postoperative delirium.

Intervention: Haloperidol 1.5 mg/d or placebo was started preoperatively and continued for up to 3 days postoperatively. Proactive geriatric consultation was provided for all randomized patients.

Measurements: The primary outcome was the incidence of postoperative delirium (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, and Confusion Assessment Method criteria). Secondary outcomes were the severity of delirium (Delirium Rating Scale, revised version-98 (DRS-R-98)), the duration of delirium, and the length of hospital stay.

Results: The overall incidence of postoperative delirium was 15.8%. The percentage of patients with postoperative delirium in the haloperidol and placebo treatment condition was 15.1% and 16.5%, respectively (relative risk=0.91, 95% confidence interval (CI)=0.6–1.3); the mean highest DRS-R-98 score±standard deviation was 14.4±3.4 and 18.4±4.3, respectively (mean difference 4.0, 95% CI=2.0–5.8; P<.001); delirium duration was 5.4 versus 11.8 days, respectively (mean difference 6.4 days, 95% CI=4.0–8.0; P<.001); and the mean number of days in the hospital was 17.1±11.1 and 22.6±16.7, respectively (mean difference 5.5 days, 95% CI=1.4–2.3; P<.001). No haloperidol-related side effects were noted.

Conclusion: Low-dose haloperidol prophylactic treatment demonstrated no efficacy in reducing the incidence of postoperative delirium. It did have a positive effect on the severity and duration of delirium. Moreover, haloperidol reduced the number of days patients stayed in the hospital, and the therapy was well tolerated.