In conclusion, the results of this study support the overall favorable safety profile, inclusive of cardiac safety parameters, of sugammadex for reversal of rocuronium- or vecuronium-induced moderate and deep neuromuscular block in ASA Class 3 or 4 participants.
AE: Adverse event; ASA: American Society of Anesthesiologists; BMI: Body mass index; CONSORT: Consolidated Standards of Reporting Trials; CR: Clinically relevant; ECI: Events of clinical interest; NMBA: Neuromuscular blockade agent; SAE: Serious adverse event; SD: Standard deviation; TE: Treatment-emergent.
Editorial assistance was provided by Amy O. Johnson-Levonas, PhD, and Sheila Erespe (both of Merck & Co., Inc., Kenilworth, NJ, USA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. The authors wish to thank the investigators below and their participants in this study.
List of investigators.
Austria: Reinhard Germann, Walter Klimscha, Harald Sparr.
Denmark: Torsten Lauritsen, Christian Meyhoff, Susanne Scheppan, Christoffer Soelling.
Germany: Manfred Blobner, Friedrich Puehringer, Alexander Reich.
USA: Richard Applegate, Neil Brister, David Broussard, Keith Candiotti, Thomas Ebert, Robert Fisher, Gary Haynes, Attila Kett, Peter Lichtenthal, Edward Liu, Shannon Meron, Harold Minkowitz, Boris Mraovic, Timothy Ness, Davinder Ramsingh, Kurt Ruetzler, Edward Sherwood, Roy Soto, Richard Urman, Matthew Wyatt.
The study was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Availability of data and materials
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA's data sharing policy, including restrictions, is available at https://engagezone.msd.com/ds_documentation.php. Requests for access to the clinical study data can be submitted through the EngageZone site or via email to firstname.lastname@example.org.
Ethics approval and consent to participate
Institutional review board committees at each site approved this randomized, active comparator-controlled, multi-site, parallel-group, double-blind safety study, conducted at 27 sites in 4 countries from December 2017 to September 2019. All participants provided written, informed consent.
Consent for publication
BMC Anesthesiol. 2021;21(259) © 2021 BioMed Central, Ltd.