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      A discrete event simulation model of clinical and operating room efficiency outcomes of sugammadex versus neostigmine for neuromuscular block reversal in Canada

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          Abstract

          Background

          The objective of this analysis is to explore potential impact on operating room (OR) efficiency and incidence of residual neuromuscular blockade (RNMB) with use of sugammadex (Bridion™, Merck & Co., Inc., Kenilworth, NJ USA) versus neostigmine for neuromuscular block reversal in Canada.

          Methods

          A discrete event simulation (DES) model was developed to compare ORs using either neostigmine or sugammadex for NMB reversal over one month. Selected inputs included OR procedure and turnover times, hospital policies for paid staff overtime and procedural cancellations due to OR time over-run, and reductions in RNMB and associated complications with sugammadex use. Trials show sugammadex’s impact on OR time and RNMB varies by whether full neuromuscular recovery (train-of-four ratio ≥0.9) is verified prior to extubation in the OR. Scenarios were therefore evaluated reflecting varied assumptions for neuromuscular reversal practices.

          Results

          With use of moderate neuromuscular block, when full neuromuscular recovery is verified prior to extubation (93 procedures performed with sugammadex, 91 with neostigmine), use of sugammadex versus neostigmine avoided 2.4 procedural cancellations due to OR time over-run and 33.5 h of paid staff overtime, while saving an average of 62 min per OR day. No difference was observed between comparators for these endpoints in the scenario when full neuromuscular recovery was not verified prior to extubation, however, per procedure risk of RNMB at extubation was reduced from 60% to 4% (reflecting 51 cases prevented), with associated reductions in risks of hypoxemia (12 cases avoided) and upper airway obstruction (23 cases avoided).

          Sugammadex impact in reversing deep neuromuscular block was evaluated in an exploratory analysis. When it was hypothetically assumed that 30 min of OR time were saved per procedure, the number of paid hours of staff over-time dropped from 84.1 to 32.0, with a 93% reduction in the per patient risk of residual blockade.

          Conclusions

          In clinical practice within Canada, for the majority of patients currently managed with moderate neuromuscular block, the principal impact of substituting sugammadex for neostigmine is likely to be a reduction in the risk of residual blockade and associated complications. For patients maintained at a deep level of block to the end of the procedure, sugammadex is likely to both enhance OR efficiency and reduce residual block complications.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s12871-016-0281-3) contains supplementary material, which is available to authorized users.

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          Most cited references25

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          Clinical significance of pulmonary aspiration during the perioperative period.

          Pulmonary aspiration of gastric contents during the perioperative period may be associated with postoperative mortality or pulmonary morbidity. Recent determination of the incidence of perioperative pulmonary aspiration and evaluation of factors related to clinical outcomes is lacking. We retrospectively reviewed the perioperative courses of 172,334 consecutive patients 18 yr of age or older who underwent 215,488 general anesthetics for procedures performed in all surgical specialties from July 1985 to June 1991. Pulmonary aspiration was defined as either the presence of bilious secretions or particulate matter in the tracheobronchial tree or, in patients who did not have their tracheobronchial airways directly examined after regurgitation, the presence of an infiltrate on postoperative chest roentgenogram that was not identified by preoperative roentgenogram or physical examination. Pulmonary aspiration occurred in 67 patients (1:3,216 anesthetics). Fifteen aspirations occurred in 13,427 (1:895) anesthetics of patients undergoing emergency surgery, and 52 occurred in 202,061 (1:3,886) anesthetics of patients undergoing elective surgery (P 10% less than the preoperative value, or radiographic abnormalities within 2 h of aspiration. These 42 patients had no respiratory sequelae. Of the 24 patients who had one or more of these findings, 13 required mechanical ventilatory support for more than 6 h. Three of the six patients whose lungs required mechanical ventilation for more than 24 h died from pulmonary insufficiency (overall mortality = 1:71,829 anesthetics). This study suggests that patients with clinically apparent aspiration who do not develop symptoms within 2 h are unlikely to have respiratory sequelae.
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            Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block.

            In this review, we summarize the clinical implications of residual neuromuscular block. Data suggest that residual neuromuscular block is a common complication in the postanesthesia care unit, with approximately 40% of patients exhibiting a train-of-four ratio <0.9. Volunteer studies have demonstrated that small degrees of residual paralysis (train-of-four ratios 0.7-0.9) are associated with impaired pharyngeal function and increased risk of aspiration, weakness of upper airway muscles and airway obstruction, attenuation of the hypoxic ventilatory response (approximately 30%), and unpleasant symptoms of muscle weakness. Clinical studies have also identified adverse postoperative events associated with intraoperative neuromuscular management. Large databased investigations have identified intraoperative use of muscle relaxants and residual neuromuscular block as important risk factors in anesthetic-related morbidity and mortality. Furthermore, observational and randomized clinical trials have demonstrated that incomplete neuromuscular recovery during the early postoperative period may result in acute respiratory events (hypoxemia and airway obstruction), unpleasant symptoms of muscle weakness, longer postanesthesia care unit stays, delays in tracheal extubation, and an increased risk of postoperative pulmonary complications. These recent data suggest that residual neuromuscular block is an important patient safety issue and that neuromuscular management affects postoperative outcomes.
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              A survey of current management of neuromuscular block in the United States and Europe.

              Postoperative residual neuromuscular block is a frequent occurrence. Recent surveys of clinical practice in Europe suggest that neuromuscular blocking drugs are often administered without appropriate monitoring. No comparable survey has been undertaken in the United States (US). From this survey, we compared current clinical neuromuscular practice and attitudes between anesthesia practitioners in the US and Europe. We conducted an Internet-based survey among anesthesia practitioners in the US and Europe. The Anesthesia Patient Safety Foundation and the European Society of Anaesthesiology e-mailed all of their active members, inviting them to anonymously answer a series of questions on a dedicated Internet Protocol address-sensitive website. The survey was available online for 60 days. The chi(2) test and Fisher's exact test were used to compare clinical survey items between the 2 cohorts. A total of 2636 completed surveys were received. Most respondents from the US (64.1%) and Europe (52.2%) estimated the incidence of clinically significant postoperative residual neuromuscular weakness to be <1% (P < 0.0001). Routine pharmacologic reversal was less common in Europe than in the US (18% vs 34.2%, respectively; P < 0.0001), and quantitative monitors were available to fewer clinicians in the US (22.7%) than in Europe (70.2%) (P < 0.0001). However, 19.3% of Europeans and 9.4% of Americans never use neuromuscular monitors. Most respondents reported that neither conventional nerve stimulators nor quantitative train-of-four monitors should be part of minimum monitoring standards. Our results suggest a lack of agreement among anesthesia providers about the best way to monitor neuromuscular function. Efforts to improve awareness by developing formal training programs and/or publishing official guidelines on best practices to reduce the incidence of postoperative neuromuscular weakness and patient morbidity are warranted.
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                Author and article information

                Contributors
                ralph_insinga@merck.com
                cedric.joyal@merck.com
                alexandra.goyette@merck.com
                andre.galarneau@merck.com
                Journal
                BMC Anesthesiol
                BMC Anesthesiol
                BMC Anesthesiology
                BioMed Central (London )
                1471-2253
                16 November 2016
                16 November 2016
                2016
                : 16
                : 114
                Affiliations
                [1 ]Department of Predictive & Economic Modeling, Merck & Co., Inc, PO Box 1000, UG1CD-32, North Wales, PA 19454-1099 USA
                [2 ]Department of Health Economics and Observational Research, 16750 Transcanada Highway, Merck Canada, Kirkland, Québec H9H 4M7 Canada
                [3 ]Department of Medical Affairs, 16750 Transcanada Highway, Merck Canada, Kirkland, Québec H9H 4M7 Canada
                Article
                281
                10.1186/s12871-016-0281-3
                5112647
                27852231
                d0ed8e05-81cb-48ef-91a2-74e72686e31a
                © The Author(s). 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 10 September 2015
                : 8 November 2016
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100004334, Merck (US);
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2016

                Anesthesiology & Pain management
                neuromuscular block,reversal,sugammadex,neostigmine,residual blockade,operating room,efficiency

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