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dc.contributor.authorAvidan, Michael Sen_US
dc.contributor.authorFritz, Bradley Aen_US
dc.contributor.authorMaybrier, Hannah Ren_US
dc.contributor.authorMuench, Maxwell Ren_US
dc.contributor.authorEscallier, Krisztina Een_US
dc.contributor.authorChen, Yulongen_US
dc.contributor.authorBen Abdallah, Arbien_US
dc.contributor.authorVeselis, Robert Aen_US
dc.contributor.authorHudetz, Judith Aen_US
dc.contributor.authorPagel, Paul Sen_US
dc.contributor.authorNoh, Gyujeongen_US
dc.contributor.authorPryor, Kaneen_US
dc.contributor.authorKaiser, Heikoen_US
dc.contributor.authorArya, Virendra Kumaren_US
dc.contributor.authorPong, Ryanen_US
dc.contributor.authorJacobsohn, Ericen_US
dc.contributor.authorGrocott, Hilary Pen_US
dc.contributor.authorChoi, Stephenen_US
dc.contributor.authorDowney, Robert Jen_US
dc.contributor.authorInouye, Sharon Ken_US
dc.contributor.authorMashour, George Aen_US
dc.date.accessioned2014-10-01T14:28:57Z
dc.date.issued2014en_US
dc.identifier.citationAvidan, M. S., B. A. Fritz, H. R. Maybrier, M. R. Muench, K. E. Escallier, Y. Chen, A. Ben Abdallah, et al. 2014. “The Prevention of Delirium and Complications Associated with Surgical Treatments (PODCAST) study: protocol for an international multicentre randomised controlled trial.” BMJ Open 4 (9): e005651. doi:10.1136/bmjopen-2014-005651. http://dx.doi.org/10.1136/bmjopen-2014-005651.en
dc.identifier.issn2044-6055en
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:12987336
dc.description.abstractIntroduction: 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).en
dc.language.isoen_USen
dc.publisherBMJ Publishing Groupen
dc.relation.isversionofdoi:10.1136/bmjopen-2014-005651en
dc.relation.hasversionhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC4166247/pdf/en
dash.licenseLAAen_US
dc.subjectProtocolen
dc.titleThe Prevention of Delirium and Complications Associated with Surgical Treatments (PODCAST) study: protocol for an international multicentre randomised controlled trialen
dc.typeJournal Articleen_US
dc.description.versionVersion of Recorden
dc.relation.journalBMJ Openen
dash.depositing.authorInouye, Sharon Ken_US
dc.date.available2014-10-01T14:28:57Z
dc.identifier.doi10.1136/bmjopen-2014-005651*
dash.authorsorderedfalse
dash.contributor.affiliatedInouye, Sharon


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