Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2014 Sep 17;4(9):e005651.
doi: 10.1136/bmjopen-2014-005651.

The Prevention of Delirium and Complications Associated with Surgical Treatments (PODCAST) study: protocol for an international multicentre randomised controlled trial

Michael S Avidan  1 , Bradley A Fritz  1 , Hannah R Maybrier  1 , Maxwell R Muench  1 , Krisztina E Escallier  1 , Yulong Chen  1 , Arbi Ben Abdallah  1 , Robert A Veselis  2 , Judith A Hudetz  3 , Paul S Pagel  4 , Gyujeong Noh  5 , Kane Pryor  6 , Heiko Kaiser  7 , Virendra Kumar Arya  8 , Ryan Pong  9 , Eric Jacobsohn  10 , Hilary P Grocott  10 , Stephen Choi  11 , Robert J Downey  12 , Sharon K Inouye  13 , George A Mashour  14
Affiliations
Randomized Controlled Trial

The Prevention of Delirium and Complications Associated with Surgical Treatments (PODCAST) study: protocol for an international multicentre randomised controlled trial

Michael S Avidan et al. BMJ Open. .

Abstract

Introduction: Postoperative delirium is one of the most common complications of major surgery, affecting 10-70% of surgical patients 60 years and older. Delirium is an acute change in cognition that manifests as poor attention and illogical thinking and is associated with longer intensive care unit (ICU) and hospital stay, long-lasting cognitive deterioration and increased mortality. Ketamine has been used as an anaesthetic drug for over 50 years and has an established safety record. Recent research suggests that, in addition to preventing acute postoperative pain, a subanaesthetic dose of intraoperative ketamine could decrease the incidence of postoperative delirium as well as other neurological and psychiatric outcomes. However, these proposed benefits of ketamine have not been tested in a large clinical trial.

Methods: The Prevention of Delirium and Complications Associated with Surgical Treatments (PODCAST) study is an international, multicentre, randomised controlled trial. 600 cardiac and major non-cardiac surgery patients will be randomised to receive ketamine (0.5 or 1 mg/kg) or placebo following anaesthetic induction and prior to surgical incision. For the primary outcome, blinded observers will assess delirium on the day of surgery (postoperative day 0) and twice daily from postoperative days 1-3 using the Confusion Assessment Method or the Confusion Assessment Method for the ICU. For the secondary outcomes, blinded observers will estimate pain using the Behavioral Pain Scale or the Behavioral Pain Scale for Non-Intubated Patients and patient self-report.

Ethics and dissemination: The PODCAST trial has been approved by the ethics boards of five participating institutions; approval is ongoing at other sites. Recruitment began in February 2014 and will continue until the end of 2016. Dissemination plans include presentations at scientific conferences, scientific publications, stakeholder engagement and popular media.

Registration details: The study is registered at clinicaltrials.gov, NCT01690988 (last updated March 2014). The PODCAST trial is being conducted under the auspices of the Neurological Outcomes Network for Surgery (NEURONS).

Trial registration number: NCT01690988 (last updated December 2013).

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flow of participants.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Whitlock EL, Vannucci A, Avidan MS. Postoperative delirium. Minerva Anestesiol 2011;77:448–56 - PMC - PubMed
    1. Leslie DL, Marcantonio ER, Zhang Y, et al. One-year health care costs associated with delirium in the elderly population. Arch Intern Med 2008;168:27–32 - PMC - PubMed
    1. Gottesman RF, Grega MA, Bailey MM, et al. Delirium after coronary artery bypass graft surgery and late mortality. Ann Neurol 2010;67:338–44 - PMC - PubMed
    1. Koster S, Hensens AG, Schuurmans MJ, et al. Consequences of delirium after cardiac operations. Ann Thorac Surg 2012;93:705–11 - PubMed
    1. Kat MG, Vreeswijk R, de Jonghe JF, et al. Long-term cognitive outcome of delirium in elderly hip surgery patients. A prospective matched controlled study over two and a half years. Dement Geriatr Cogn Disord 2008;26:1–8 - PubMed

Publication types

MeSH terms

Associated data