{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T12:21:23Z","timestamp":1777378883373,"version":"3.51.4"},"reference-count":10,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2022,12,15]],"date-time":"2022-12-15T00:00:00Z","timestamp":1671062400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Anaesth Intensive Care"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:p>Rocuronium bromide is a neuromuscular blocker in widespread use in anaesthesia, emergency and intensive care. Reports of reduced efficacy of a new different formulation of rocuronium bromide were submitted to Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, in 2020. Given the requirement for rapid and predictable paralysis for patient safety the efficacy of the two available formulations of rocuronium bromide was investigated in an animal model. After ethics committee approval, 19 rats were anaesthetised and paralysis, defined as loss of tibialis anterior flexion on direct electrical stimulation of the sciatic nerve, was assessed by mechanomyography in response to ED90 doses of rocuronium.<\/jats:p>\n                  <jats:p>Paralysis was observed at a median of 12 seconds for the new different formulation: A, Hameln Pharma (interquartile range (IQR) 6\u2013106 seconds) and 28 seconds for formulation B: Pfizer (IQR 12\u201368 seconds) P\u2009=\u20090.48. Offset of paralysis was observed after 293 seconds for formulation A (IQR 250\u2013372 seconds) and 241 seconds for formulation B (IQR 220\u2013263 seconds). While the differences observed were substantial, they were not statistically significant. Moreover, the direction of observed difference was towards a shorter median onset and longer offset for the newer formulation, a finding in the opposite direction to the initial clinical concern.<\/jats:p>\n                  <jats:p>Relevance to the clinical situation is indeterminate given the study was stopped at low numbers for futility and limitations around the clinical applicability of animal pharmacokinetics and dynamics. Nevertheless our findings provide some reassurance that the newly available different formulation of this critical use medication does not exhibit a substantial increase in time to onset.<\/jats:p>","DOI":"10.1177\/0310057x221111182","type":"journal-article","created":{"date-parts":[[2022,12,16]],"date-time":"2022-12-16T02:47:38Z","timestamp":1671158858000},"page":"38-42","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparison of the onset and offset times of two available formulations of rocuronium bromide in an animal model"],"prefix":"10.1177","volume":"51","author":[{"given":"Louise M","family":"Speedy","sequence":"first","affiliation":[{"name":"Intensive Care Unit, Hawkes Bay District Health Board, Hastings, New Zealand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6240-337X","authenticated-orcid":false,"given":"Sean","family":"O\u2019Beirn","sequence":"additional","affiliation":[{"name":"Intensive Care Unit, Hawkes Bay District Health Board, Hastings, New Zealand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gary","family":"Hopgood","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia, Waikato District Health Board, Hamilton, New Zealand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martyn G","family":"Harvey","sequence":"additional","affiliation":[{"name":"Emergency Department, Waikato District Health Board, Hamilton, New Zealand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9992-8252","authenticated-orcid":false,"given":"Grant","family":"Cave","sequence":"additional","affiliation":[{"name":"Intensive Care Unit, Hawkes Bay District Health Board, Hastings, New Zealand"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2022,12,15]]},"reference":[{"key":"bibr1-0310057X221111182","unstructured":"Medsafe.\n                      Rocuronium bromide Hameln, lack of efficacy\n                      . 31 July 2020. 31 July 2020. https:\/\/www.medsafe.govt.nz\/safety\/Alerts\/Rocuronium.asp (accessed 12 December 2021)."},{"key":"bibr2-0310057X221111182","unstructured":"Martin H.\n                      Medsafe monitoring drug used in anaesthesia over reports of \u201clack of effiacacy\u201d\n                      . Stuff. 7 August 2020. https:\/\/www.stuff.co.nz\/national\/health\/300074922\/medsafe-monitoring-drug-used-in-anaesthesia-over-reports-of-lack-of-efficacy (accessed 12 December 2021)."},{"key":"bibr3-0310057X221111182","unstructured":"Boucheix O, Coquard D, Coston R.\n                      Model of neuromuscular block reversal in the anaesthetised rat\n                      . https:\/\/www.criver.com\/sites\/default\/files\/resources\/ModelofNeuromuscularBlockReversalintheAnaesthetisedRat.pdf (accessed 12 December 2021)."},{"key":"bibr4-0310057X221111182","doi-asserted-by":"publisher","DOI":"10.1111\/aas.13645"},{"key":"bibr5-0310057X221111182","doi-asserted-by":"publisher","DOI":"10.3758\/BRM.42.1.3"},{"key":"bibr6-0310057X221111182","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-443-06959-8.00029-7"},{"key":"bibr7-0310057X221111182","unstructured":"Max Health Limited. 2021. New Zealand Data Sheet Rocuronium Bromide. https:\/\/www.medsafe.govt.nz\/profs\/datasheet\/r\/rocuroniumbromideinj.pdf (accessed 12 December 2021)."},{"key":"bibr8-0310057X221111182","unstructured":"Pfizer New Zealand Limited. 2019. New Zealand Data Sheet DBL Rocuronium Bromide Injection. https:\/\/www.medsafe.govt.nz\/profs\/Datasheet\/d\/dblrocuroniuminj.pdf (accessed 12 December 2021)."},{"key":"bibr9-0310057X221111182","unstructured":"Taranaki Reporters. Refrigerated ship used to get Taranaki beef to the USA, due to container shortage. Stuff. 3 February 2022. https:\/\/www.stuff.co.nz\/taranaki-daily-news\/news\/300510062\/refrigerated-ship-used-to-get-taranaki-beef-to-the-usa-due-to-container-shortage (accessed 15 February 2022)."},{"key":"bibr10-0310057X221111182","unstructured":"Tobin C. Global freight disruptions impacting exporters and cool store operators. Stuff. 21 March 2021. https:\/\/www.stuff.co.nz\/timaru-herald\/news\/124594274\/global-freight-disruptions-impacting-exporters-and-cool-store-operators (accessed 15 February 2022)."}],"container-title":["Anaesthesia and Intensive Care"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0310057X221111182","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/0310057X221111182","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0310057X221111182","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T09:12:34Z","timestamp":1777367554000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/0310057X221111182"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,12,15]]},"references-count":10,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2023,1]]}},"alternative-id":["10.1177\/0310057X221111182"],"URL":"https:\/\/doi.org\/10.1177\/0310057x221111182","relation":{},"ISSN":["0310-057X","1448-0271"],"issn-type":[{"value":"0310-057X","type":"print"},{"value":"1448-0271","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,12,15]]}}}