2.A randomized trial evaluating the safety profile of sugammadex in high surgical risk ASA physical class 3 or 4 participants
W. Herring JOSEPH ; Yuki MUKAI ; Aobo WANG ; Jeannine LUTKIEWICZ ; F. John LOMBARD ; Li LIN ; Molly WATKINS ; M. David BROUSSARD ; Manfred BLOBNER
Chinese Journal of Anesthesiology 2022;42(1):16-23
Objective:The aim of this randomized, double-blind trial was to evaluate the safety and tolerability profile, including cardiac safety, of sugammadex-mediated recovery from neuromuscular block in participants undergoing surgery who met the American Society of Anesthesiologists (ASA) Physical Class 3 or 4 criteria.Specifically, this study assessed the impact of sugammadex on cardiac adverse events (AEs) and other prespecified AEs of clinical interest.Methods:Participants meeting ASA Class 3 and 4 criteria were stratified by ASA Class and NMBA (rocuronium or vecuronium) then randomized to one of the following: 1) Moderate neuromuscular block, sugammadex 2 mg/kg; 2) Moderate neuromuscular block, neostigmine and glycopyrrolate (neostigmine/glycopyrrolate); 3) Deep neuromuscular block, sugammadex 4 mg/kg; 4) Deep neuromuscular block, sugammadex 16 mg/kg (rocuronium only). Primary endpoints included incidences of treatment-emergent (TE) sinus bradycardia, TE sinus tachycardia and other TE cardiac arrhythmias.Results:Of 344 participants randomized, 331 received treatment (61% male, BMI 28.5 ± 5.3 kg/m 2, age 69 ± 11 years). Incidence of TE sinus bradycardia was significantly lower in the sugammadex 2 mg/kg group vs neostigmine/glycopyrrolate.The incidence of TE sinus tachycardia was significantly lower in the sugammadex 2 and 4 mg/kg groups vs neostigmine/glycopyrrolate.No significant differences in other TE cardiac arrythmias were seen between sugammadex groups and neostigmine/glycopyrrolate.There were no cases of adjudicated anaphylaxis or hypersensitivity reactions in this study. Conclusions:Compared with neostigmine/glycopyrrolate, incidence of TE sinus bradycardia was significantly lower with sugammadex 2 mg/kg and incidence of TE sinus tachycardia was significantly lower with sugammadex 2 mg/kg and 4 mg/kg.These results support the safety of sugammadex for reversing rocuronium- or vecuronium-induced moderate and deep neuromuscular block in ASA Class 3 or 4 participants.
3.Effectiveness of 5-day Post-exposure Prophylactic Oseltamivir and Its Effect on Hospital Management
Takayuki MOKUBO ; Mayuko HAMADA ; Yasutomo ISHII ; Aya MIYAMOTO ; Koichiro MUKAI ; Yuki TOKUTAKE ; Koji UEDA ; Hiroshi MATSUOKA
Journal of the Japanese Association of Rural Medicine 2021;69(5):489-493
Prophylaxis is sometimes offered to inpatients who share a room with, or individuals who have been in close contact with, patients who have contracted influenza. In our hospital, 5-day prophylactic oseltamivir has been used as a standard procedure. Here, we investigated the effectiveness of this post-exposure prophylaxis for inpatients and healthcare professionals, as well as its effect on hospital management. The study period was 5 years from fiscal year 2013 to fiscal year 2017, and the effectiveness outcome was the secondary infection rate. Medication costs for this prophylaxis were compared with those for oseltamivir used according to the package insert. The secondary infection rates were 3.0% and 0.5% in 133 inpatients and 434 healthcare professionals who had received post-exposure oseltamivir, respectively. The medication costs were reduced by 50% compared with the estimated costs for 10-day oseltamivir administration. The effectiveness of 5-day prophylactic oseltamivir was similar to or higher than that reported previously, indicating that this prophylaxis was effective. Moreover, 5-day post-exposure prophylactic oseltamivir is expected to reduce the prolongation of hospital stay and influenza outbreaks and thus contribute to hospital management.