title: The Prevention of Delirium and Complications Associated with Surgical Treatments (PODCAST) study: protocol for an international multicentre randomised controlled trial.
abstract: BACKGROUND
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  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).
  
  
  BACKGROUND
  NCT01690988 (last updated December 2013).
authors.affiliation: Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Avidan
authors.affiliation: Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
authors.forename: Bradley A
authors.initials: BA
authors.lastname: Fritz
authors.affiliation: Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
authors.forename: Hannah R
authors.initials: HR
authors.lastname: Maybrier
authors.affiliation: Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
authors.forename: Maxwell R
authors.initials: MR
authors.lastname: Muench
authors.affiliation: Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
authors.forename: Krisztina E
authors.initials: KE
authors.lastname: Escallier
authors.affiliation: Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
authors.forename: Yulong
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
authors.forename: Arbi
authors.initials: A
authors.lastname: Ben Abdallah
authors.affiliation: Department of Anesthesiology, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Veselis
authors.affiliation: Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
authors.forename: Judith A
authors.initials: JA
authors.lastname: Hudetz
authors.affiliation: Clement J. Zablocki VA Medical Center, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
authors.forename: Paul S
authors.initials: PS
authors.lastname: Pagel
authors.affiliation: Department of Anesthesiology, Asan Medical Center, Seoul, South Korea.
authors.forename: Gyujeong
authors.initials: G
authors.lastname: Noh
authors.affiliation: Department of Anesthesiology, Weill Cornell Medical College, New York, New York, USA.
authors.forename: Kane
authors.initials: K
authors.lastname: Pryor
authors.affiliation: Department of Anesthesiology, University of Bern, Bern, Switzerland.
authors.forename: Heiko
authors.initials: H
authors.lastname: Kaiser
authors.affiliation: Department of Anesthesiology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Virendra Kumar
authors.initials: VK
authors.lastname: Arya
authors.affiliation: Department of Anesthesiology, Virginia Mason Medical Center, Seattle, Washington, USA.
authors.forename: Ryan
authors.initials: R
authors.lastname: Pong
authors.affiliation: Department of Anesthesiology, University of Manitoba-Faculty of Medicine, Winnipeg, Manitoba, Canada.
authors.forename: Eric
authors.initials: E
authors.lastname: Jacobsohn
authors.affiliation: Department of Anesthesiology, University of Manitoba-Faculty of Medicine, Winnipeg, Manitoba, Canada.
authors.forename: Hilary P
authors.initials: HP
authors.lastname: Grocott
authors.affiliation: Department of Anesthesiology, Sunnybrook Health Sciences Center, Toronto, Ontario, Canada.
authors.forename: Stephen
authors.initials: S
authors.lastname: Choi
authors.affiliation: Department of Surgery, Thoracic, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Downey
authors.affiliation: Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Hebrew SeniorLife, Boston, Massachusetts, USA.
authors.forename: Sharon K
authors.initials: SK
authors.lastname: Inouye
authors.affiliation: Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, Michigan, USA.
authors.forename: George A
authors.initials: GA
authors.lastname: Mashour
mesh_terms: D000778:Anesthetics, Dissociative / Q000627:therapeutic use*; D002985:Clinical Protocols; D003693:Delirium / Q000517:prevention & control*; D004311:Double-Blind Method; D006801:Humans; D007649:Ketamine / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies
chemical_list: D000778:Anesthetics, Dissociative; D007649:Ketamine