You are here

  • Home
  • Archive
  • Volume 4, Issue 9
  • The Prevention of Delirium and Complications Associated with Surgical Treatments (PODCAST) study: protocol for an international multicentre randomised controlled trial

Article Text

Article menu
XML
Anaesthesia
Protocol
The Prevention of Delirium and Complications Associated with Surgical Treatments (PODCAST) study: protocol for an international multicentre randomised controlled trial
  1. Michael S Avidan1,
  2. Bradley A Fritz1,
  3. Hannah R Maybrier1,
  4. Maxwell R Muench1,
  5. Krisztina E Escallier1,
  6. Yulong Chen1,
  7. Arbi Ben Abdallah1,
  8. Robert A Veselis2,
  9. Judith A Hudetz3,
  10. Paul S Pagel4,
  11. Gyujeong Noh5,
  12. Kane Pryor6,
  13. Heiko Kaiser7,
  14. Virendra Kumar Arya8,
  15. Ryan Pong9,
  16. Eric Jacobsohn10,
  17. Hilary P Grocott10,
  18. Stephen Choi11,
  19. Robert J Downey12,
  20. Sharon K Inouye13,
  21. George A Mashour14
  1. 1Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA
  2. 2Department of Anesthesiology, Memorial Sloan-Kettering Cancer Center, New York, New York, USA
  3. 3Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA
  4. 4Clement J. Zablocki VA Medical Center, Medical College of Wisconsin, Milwaukee, Wisconsin, USA
  5. 5Department of Anesthesiology, Asan Medical Center, Seoul, South Korea
  6. 6Department of Anesthesiology, Weill Cornell Medical College, New York, New York, USA
  7. 7Department of Anesthesiology, University of Bern, Bern, Switzerland
  8. 8Department of Anesthesiology, Postgraduate Institute of Medical Education and Research, Chandigarh, India
  9. 9Department of Anesthesiology, Virginia Mason Medical Center, Seattle, Washington, USA
  10. 10Department of Anesthesiology, University of Manitoba-Faculty of Medicine, Winnipeg, Manitoba, Canada
  11. 11Department of Anesthesiology, Sunnybrook Health Sciences Center, Toronto, Ontario, Canada
  12. 12Department of Surgery, Thoracic, Memorial Sloan-Kettering Cancer Center, New York, New York, USA
  13. 13Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Hebrew SeniorLife, Boston, Massachusetts, USA
  14. 14Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, Michigan, USA
  1. Correspondence to Dr Michael S Avidan; avidanm{at}anest.wustl.edu

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).

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2014-005651

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Supplementary materials

    • Supplementary Data

      This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

      Files in this Data Supplement: