European Journal of Anaesthesiology最新文献

{"title":"The novel rapid formulation of intravenous dantrolene (NPJ5008) versus standard dantrolene (Dantrium®): A clinical part-randomised phase 1 study in healthy volunteers.","authors":"Richard H Ng Kwet Shing, Lucy B Clayton, Samuel L Smith, Marc J Watson, Litza M McKenzie, David P Chalmers, Gareth Whitaker, Jonathan G Bilmen","doi":"10.1097/EJA.0000000000001966","DOIUrl":"10.1097/EJA.0000000000001966","url":null,"abstract":"<p><strong>Background: </strong>Delays in treating anaesthesia-induced malignant hyperthermia increase risks of complications and death. NPJ5008 is a novel formulation of the indicated treatment, dantrolene sodium, developed to shorten preparation and administration times compared with the reference formulation Dantrium®. The two formulations have been compared preclinically.</p><p><strong>Objectives: </strong>Assess bioequivalence of overall dantrolene (free acid) exposure of NPJ5008 versus Dantrium® and ascertain similarities in their pharmacokinetics and safety/tolerability profiles. Evaluate preparation/administration time savings for the new formulation.</p><p><strong>Design: </strong>Part 1 of this open-label trial in humans was a 1 : 1 randomised crossover study; part 2 was a single-arm study. Trial pharmacy data and laboratory simulations assessed preparation/administration step timings.</p><p><strong>Setting: </strong>Single clinical centre in the UK, April to July 2021.</p><p><strong>Participants: </strong>Twenty-one healthy male and female individuals.</p><p><strong>Interventions: </strong>Part 1: single intravenous 60 mg dose of NPJ5008 or Dantrium®, sequentially. Part 2: single intravenous 120 mg dose of NPJ5008. Simulation: five vials per formulation using paediatric and adult cannulas.</p><p><strong>Main outcome measures: </strong>Overall drug exposure to last measurable concentration (AUC 0 to last ) and extrapolated to infinity (AUC 0 to ∞ ) were primary endpoints. Other pharmacokinetic, clinical and muscle-function parameters, and adverse events, were monitored.</p><p><strong>Results: </strong>Adjusted geometric mean ratios of NPJ5008 versus Dantrium® were 90.24 and 90.44% for AUC 0 to last and AUC 0 to ∞ , respectively, with the 90% confidence intervals (CI) within the 80 to 125% acceptance interval, establishing bioequivalence. No new safety issues emerged: any adverse events were of a similar magnitude across treatments and related to pharmacological properties of dantrolene. Pharmacy and simulation data revealed that every step in preparation and administration was 26 to 69% faster for NPJ5008 than Dantrium®.</p><p><strong>Conclusion: </strong>NPJ5008 showed comparable pharmacokinetic and safety profiles to Dantrium®, while reducing dantrolene dose preparation/administration times, potentially reducing patient complications/healthcare resourcing in malignant hyperthermia.</p><p><strong>Trial registration: </strong>EudraCT Number: 2020-005719-35, MHRA approval.</p>","PeriodicalId":11920,"journal":{"name":"European Journal of Anaesthesiology","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10990017/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140038981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of sugammadex and neostigmine on outcome after major orthopaedic surgery: A population-based analysis.","authors":"Crispiana Cozowicz, Haoyan Zhong, Jashvant Poeran, Alex Illescas, Jiabin Liu, Lazaros A Poultsides, Vassilis Athanassoglou, Stavros G Memtsoudis","doi":"10.1097/EJA.0000000000001979","DOIUrl":"10.1097/EJA.0000000000001979","url":null,"abstract":"<p><strong>Background: </strong>Residual neuromuscular blockade after surgery remains a major concern given its association with pulmonary complications. However, current clinical practices with and the comparative impact on perioperative risk of various reversal agents remain understudied.</p><p><strong>Objective: </strong>We investigated the use of sugammadex and neostigmine in the USA, and their impact on postoperative complications by examining national data.</p><p><strong>Design: </strong>This population-based retrospective study used national Premier Healthcare claims data.</p><p><strong>Setting and participants: </strong>Patients undergoing total hip/knee arthroplasty (THA, TKA), or lumbar spine fusion surgery between 2016 and 2019 in the United States who received neuromuscular blocking agents.</p><p><strong>Intervention: </strong>The effects of sugammadex and neostigmine for pharmacologically enhanced reversal were compared with each other and with controls who received no reversal agent.</p><p><strong>Main outcomes: </strong>included pulmonary complications, cardiac complications, and a need for postoperative ventilation. Mixed-effects regression models compared the outcomes between neostigmine, sugammadex, and controls. We report odds ratios (OR) and 95% confidence intervals (CI). Bonferroni-adjusted P values of 0.008 were used to indicate significance.</p><p><strong>Results: </strong>Among 361 553 patients, 74.5% received either sugammadex (20.7%) or neostigmine (53.8%). Sugammadex use increased from 4.4% in 2016 to 35.4% in 2019, whereas neostigmine use decreased from 64.5% in 2016 to 43.4% in 2019. Sugammadex versus neostigmine or controls was associated with significantly reduced odds for cardiac complications (OR 0.86, 95% CI, 0.80 to 0.92 and OR 0.83, 95% CI, 0.78 to 0.89, respectively). Both sugammadex and neostigmine versus controls were associated with reduced odds for pulmonary complications (OR 0.85, 95% CI, 0.77 to 0.94 and OR 0.91, CI 0.85 to 0.98, respectively). A similar pattern of sugammadex and neostigmine was observed for a reduction in severe pulmonary complications, including the requirement of invasive ventilation (OR 0.54, 95% CI, 0.45 to 0.64 and OR 0.53, 95% CI, 0.46 to 0.6, respectively).</p><p><strong>Conclusions: </strong>Population-based data indicate that sugammadex and neostigmine both appear highly effective in reducing the odds of severe life-threatening pulmonary complications. Sugammadex, especially, was associated with reduced odds of cardiac complications.</p>","PeriodicalId":11920,"journal":{"name":"European Journal of Anaesthesiology","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140143007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Continuous monitoring of vital signs and clinical deterioration in frail elderly cardiac surgery patients: AGE AWARE study: A prospective cohort study.","authors":"Britta C Arends, H. V. Oud-Alblas, E. V. Dongen, Douwe H. Biesma, L. Vernooij, P. Noordzij","doi":"10.1097/EJA.0000000000001995","DOIUrl":"https://doi.org/10.1097/EJA.0000000000001995","url":null,"abstract":"","PeriodicalId":11920,"journal":{"name":"European Journal of Anaesthesiology","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140652239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevalence and adverse effects of peri-operative potentially inappropriate medication in the elderly.","authors":"Elena Sandín-López, Inés M Galan-López, Enrique Candelas-Cancela, Bartolomé Fernández-Torres","doi":"10.1097/EJA.0000000000001994","DOIUrl":"https://doi.org/10.1097/EJA.0000000000001994","url":null,"abstract":"","PeriodicalId":11920,"journal":{"name":"European Journal of Anaesthesiology","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140652280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of preoxygenation using a tight facemask, humidified high-flow nasal oxygen and a standard nasal cannula - a volunteer, randomised, crossover study.","authors":"Albin Sjöblom, Magnus Hedberg, Ida-Maria Forsberg, Frida Hoffman, Malin Jonsson Fagerlund","doi":"10.1097/eja.0000000000001989","DOIUrl":"https://doi.org/10.1097/eja.0000000000001989","url":null,"abstract":"Preoxygenation before anaesthesia induction is routinely performed via a tight-fitting facemask or humidified high-flow nasal oxygen. We hypothesised that effective preoxygenation, assessed by end-tidal oxygen (EtO2) levels, can also be performed via a standard nasal cannula.","PeriodicalId":11920,"journal":{"name":"European Journal of Anaesthesiology","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140623578","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Thank you to our Reviewers 2023","authors":"","doi":"10.1097/eja.0000000000001982","DOIUrl":"https://doi.org/10.1097/eja.0000000000001982","url":null,"abstract":"","PeriodicalId":11920,"journal":{"name":"European Journal of Anaesthesiology","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140743663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Response to: reply to: regional anaesthesia in patients on antithrombotic drugs.","authors":"Torger Aarstad Aase, L. Rosseland","doi":"10.1097/EJA.0000000000001963","DOIUrl":"https://doi.org/10.1097/EJA.0000000000001963","url":null,"abstract":"","PeriodicalId":11920,"journal":{"name":"European Journal of Anaesthesiology","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140743513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Peri-operative cardiac arrest and resuscitation: Towards an innovative, physiologically based road map.","authors":"Athanasios Chalkias, S. Mentzelopoulos, R. Tissier, Nicolas Mongardon","doi":"10.1097/EJA.0000000000001944","DOIUrl":"https://doi.org/10.1097/EJA.0000000000001944","url":null,"abstract":"","PeriodicalId":11920,"journal":{"name":"European Journal of Anaesthesiology","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140745590","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"What is a low low-molecular-weight heparin dose?","authors":"A. Godier, J. V. Llau, R. Ferrandis, Sibylle Langenecker","doi":"10.1097/EJA.0000000000001962","DOIUrl":"https://doi.org/10.1097/EJA.0000000000001962","url":null,"abstract":"","PeriodicalId":11920,"journal":{"name":"European Journal of Anaesthesiology","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140745854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Alternatives to the in-person anaesthetist-led preoperative assessment in adults undergoing low-risk or intermediate-risk surgery. A scoping review: putting an end to ‘semper idem’","authors":"Corina Bello, Michael A Harnik, Markus M Luedi, Thomas Heidegger","doi":"10.1097/EJA.0000000000001887","DOIUrl":"https://doi.org/10.1097/EJA.0000000000001887","url":null,"abstract":"","PeriodicalId":11920,"journal":{"name":"European Journal of Anaesthesiology","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140744005","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}