{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T06:11:49Z","timestamp":1790748709596,"version":"4.1.0"},"reference-count":32,"publisher":"BMJ","issue":"6","funder":[{"name":"French Ministry of Health"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2018,5,21]]},"published-print":{"date-parts":[[2018,6]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Reducing opioid consumption during and after surgery has been recommended for more than 10 years. Opioid-free anaesthesia (OFA) is a multimodal anaesthesia associating hypnotics, NMDA antagonists, local anaesthetics, anti-inflammatory drugs and \u03b1-2 agonists. Proofs of the effect of OFA on reducing opioid-related adverse effects after major or intermediate non-cardiac surgery are still scarce. We hypothesised that the reduced opioid consumption allowed by OFA compared with standard of care will be associated with a reduction of postoperative opioid-related adverse events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods\/analysis<\/jats:title>\n                    <jats:p>The POFA trial is a prospective, randomised, parallel, single-blind, multicentre study of 400 patients undergoing elective intermediate or major non-cardiac surgery. Patients will be randomly allocated to receive either a standard anaesthesia protocol or an OFA. The primary outcome measure is the occurrence of a severe postoperative opioid-related adverse event within the first 48\u2009hours after extubation defined as: postoperative hypoxaemia or postoperative ileus or postoperative cognitive dysfunction. In addition, each component of the primary outcome measure will be analysed separately. Data will be analysed on the intention-to-treat principle and a per-protocol basis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The POFA trial has been approved by an independent ethics committee for all study centres. Participant recruitment begins in November 2017. Results will be published in international peer-reviewed medical journals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"NCT03316339\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\">NCT03316339<\/jats:ext-link>\n                      ; Pre-results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2017-020873","type":"journal-article","created":{"date-parts":[[2018,6,30]],"date-time":"2018-06-30T05:25:31Z","timestamp":1530336331000},"page":"e020873","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":36,"title":["POFA trial study protocol: a multicentre, double-blind, randomised, controlled clinical trial comparing opioid-free versus opioid anaesthesia on postoperative opioid-related adverse events after major or intermediate non-cardiac surgery"],"prefix":"10.1136","volume":"8","clinical-trial-number":[{"clinical-trial-number":"nct03316339","registry":"10.18810\/clinical-trials-gov","type":"preResults"},{"clinical-trial-number":"nct03316339","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Helene","family":"Beloeil","sequence":"first","affiliation":[{"name":"CHU Rennes, P\u00f4le Anesth\u00e9sie et R\u00e9animation, Inserm, NuMeCan, CIC 1414 and Universit\u00e9 de Rennes 1, Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Laviolle","sequence":"additional","affiliation":[{"name":"Univ Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d\u2019investigation clinique de Rennes, service de pharmacologie clinique), Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cedric","family":"Menard","sequence":"additional","affiliation":[{"name":"CHU de Rennes, P\u00f4le de Biologie, Rennes, France"},{"name":"INSERM, UMR U1236, Universit\u00e9 Rennes 1, EFS Bretagne, Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Paugam-Burtz","sequence":"additional","affiliation":[{"name":"D\u00e9partement Anesth\u00e9sie R\u00e9animation, Assistance publique-H\u00f4pitaux de Paris (AP-HP), H\u00f4pital Beaujon, H\u00f4pitaux Universitaires Paris Nord Val de Seine, and Universit\u00e9 Paris Diderot, Clichy, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"Garot","sequence":"additional","affiliation":[{"name":"Centre Hospitalier Universitaire (CHU) Lille, P\u00f4le Anesthesie R\u00e9animation, Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karim","family":"Asehnoune","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Critical Care Medicine, Centre hospitalier universitaire (CHU) de Nantes, Nantes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincent","family":"Minville","sequence":"additional","affiliation":[{"name":"D\u00e9partement d\u2019Anesth\u00e9sie et de R\u00e9animation, Centre Hospitalier et Universitaire de Toulouse, Toulouse, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Cuvillon","sequence":"additional","affiliation":[{"name":"Service Anesth\u00e9sie, P\u00f4le Anesth\u00e9sie R\u00e9animation Douleur Urgence, Centre Hospitalier Universitaire Car\u00e9meau, Nimes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastien","family":"Oger","sequence":"additional","affiliation":[{"name":"Centre Hospitalier de P\u00e9rigueux, P\u00f4le Bloc Anesth\u00e9sie Chirurgie, Service d\u2019anesth\u00e9siologie, Perigueux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julien","family":"Nadaud","sequence":"additional","affiliation":[{"name":"Centre Hospitalier Metz Thionville, P\u00f4le Anesthesie R\u00e9animation, Metz, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvain","family":"Lecoeur","sequence":"additional","affiliation":[{"name":"Centre Hospitalier Yves le Foll, P\u00f4le Anesthesie R\u00e9animation, Saint-Brieuc, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerald","family":"Chanques","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia and Critical Care Medicine, University of Montpellier Saint Eloi Hospital, PhyMedExp, University of Montpellier, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Futier","sequence":"additional","affiliation":[{"name":"D\u00e9partement de M\u00e9decine P\u00e9riop\u00e9ratoire, Universit\u00e9 Clermont Auvergne, GreD, CNRS, Inserm U1103, Centre Hospitalier Universitaire (CHU) Clermont-Ferrand, Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2018,6,30]]},"reference":[{"key":"2025121400511598000_8.6.e020873.1","doi-asserted-by":"publisher","DOI":"10.1097\/00000542-199909000-00022"},{"key":"2025121400511598000_8.6.e020873.2","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/89.5.697"},{"key":"2025121400511598000_8.6.e020873.3","doi-asserted-by":"crossref","first-page":"677","DOI":"10.1185\/03007995.2015.1005833","article-title":"Impact of postsurgical opioid use and ileus on economic outcomes in gastrointestinal surgeries","volume":"31","author":"Gan","year":"2015","journal-title":"Curr Med Res Opin"},{"key":"2025121400511598000_8.6.e020873.4","doi-asserted-by":"publisher","DOI":"10.1097\/01.JGP.0000229792.31009.da"},{"key":"2025121400511598000_8.6.e020873.5","doi-asserted-by":"publisher","DOI":"10.1097\/ALN.0000000000000564"},{"key":"2025121400511598000_8.6.e020873.6","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/aeu137"},{"key":"2025121400511598000_8.6.e020873.7","doi-asserted-by":"publisher","DOI":"10.1007\/s10555-011-9285-0"},{"key":"2025121400511598000_8.6.e020873.8","doi-asserted-by":"publisher","DOI":"10.1097\/00000542-200507000-00022"},{"key":"2025121400511598000_8.6.e020873.9","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/aes247"},{"key":"2025121400511598000_8.6.e020873.10","doi-asserted-by":"publisher","DOI":"10.1097\/ALN.0b013e3181fc6e0a"},{"key":"2025121400511598000_8.6.e020873.11","doi-asserted-by":"publisher","DOI":"10.1097\/00000539-199901000-00040"},{"key":"2025121400511598000_8.6.e020873.12","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/68.1.23"},{"key":"2025121400511598000_8.6.e020873.13","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1213\/00000539-198908000-00012","article-title":"Early postoperative arterial oxygen desaturation. Determining factors and response to oxygen therapy","volume":"69","author":"Canet","year":"1989","journal-title":"Anesth Analg"},{"key":"2025121400511598000_8.6.e020873.14","doi-asserted-by":"crossref","first-page":"898","DOI":"10.1213\/ANE.0000000000000216","article-title":"Cognitive outcome of surgery: is there no place like home?","volume":"118","author":"Crosby","year":"2014","journal-title":"Anesth Analg"},{"key":"2025121400511598000_8.6.e020873.15","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/aeu442"},{"key":"2025121400511598000_8.6.e020873.16","doi-asserted-by":"publisher","DOI":"10.1213\/ANE.0000000000000194"},{"key":"2025121400511598000_8.6.e020873.17","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(03)14966-5"},{"key":"2025121400511598000_8.6.e020873.18","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinane.2005.05.009"},{"key":"2025121400511598000_8.6.e020873.19","doi-asserted-by":"publisher","DOI":"10.1007\/BF03027725"},{"key":"2025121400511598000_8.6.e020873.20","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/aew024"},{"key":"2025121400511598000_8.6.e020873.21","doi-asserted-by":"crossref","first-page":"191","DOI":"10.1016\/j.bjan.2014.05.006","article-title":"[Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study]","volume":"65","author":"Bakan","year":"2015","journal-title":"Rev Bras Anestesiol"},{"key":"2025121400511598000_8.6.e020873.22","doi-asserted-by":"publisher","DOI":"10.1007\/s00540-011-1239-8"},{"key":"2025121400511598000_8.6.e020873.23","doi-asserted-by":"publisher","DOI":"10.1097\/ALN.0b013e31825681cb"},{"key":"2025121400511598000_8.6.e020873.24","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2013.03.029"},{"key":"2025121400511598000_8.6.e020873.25","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/aet551"},{"key":"2025121400511598000_8.6.e020873.26","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehu282"},{"key":"2025121400511598000_8.6.e020873.27","doi-asserted-by":"crossref","first-page":"1066","DOI":"10.1016\/j.bja.2018.02.007","article-title":"A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications","volume":"120","author":"Abbott","year":"2018","journal-title":"Br J Anaesth"},{"key":"2025121400511598000_8.6.e020873.28","doi-asserted-by":"publisher","DOI":"10.1111\/j.1532-5415.2005.53120.x"},{"key":"2025121400511598000_8.6.e020873.29","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-113-12-941"},{"key":"2025121400511598000_8.6.e020873.30","doi-asserted-by":"publisher","DOI":"10.2174\/138161212803582496"},{"key":"2025121400511598000_8.6.e020873.31","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.c332"},{"key":"2025121400511598000_8.6.e020873.32","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199701233360422"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2017-020873","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T08:51:22Z","timestamp":1765702282000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2017-020873"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,6]]},"references-count":32,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2018,6,30]]},"published-print":{"date-parts":[[2018,6]]}},"alternative-id":["10.1136\/bmjopen-2017-020873"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2017-020873","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,6]]}}}