5: Sugammadex vs Placebo in Icu Patients After Undergoing Cardiopulmonary Bypass

Introduction: Recent literature has indicated potential advantages of neuromuscular blockade (NMB) reversal in cardiac surgery patients. However, outcome data is limited in sicker elective/urgent cardiac surgical patients monitored for residual NMB (rNMB). We hypothesize that sugammadex will increase the number of patients meeting the Society of Thoracic Surgery (STS) extubation criteria within 6 hours of procedure end. Methods: With Endeavor Health IRB approval and written informed consent, 64 ASA 3-4 elective/urgent cardiac surgery patients undergoing cardiopulmonary bypass were randomized to receive sugammadex or placebo 15 minutes after arriving in the ICU. Surgeons and ICU nurses were blinded. The primary outcome was the number of patients meeting the STS quality benchmark. Secondary outcomes included time to extubation, achieving train of four (TOF) ratio ≥0.9 before extubation (a marker for appropriate clinical neuromuscular strength), reintubation, and post-extubation pneumonia/hypoxemia. Hypoxemia was defined by the Berlin criteria and PaO2/FiO2 ratios were approximated using validated SpO2/FiO2 ratios. Results: There were no demographic differences between the sugammadex and placebo groups with the exception of CV bypass duration (p=0.0177), surgery duration (p=0.0004), and intraoperative blood products (p=0.0003) which were greater in the sugammadex group. There was no difference in the primary outcome between groups. A significant increase in the number of patients who achieved TOF ≥0.9 prior to extubation was observed in the sugammadex vs. placebo group (p < 0.0001). All patients in the sugammadex group achieved TOF ≥0.9 prior to extubation compared to 37.5% of the placebo group. No other secondary outcome differences were observed. Conclusions: This double-blind RCT suggests no difference in the number of patients extubated within the 6-hour STS window which may be attributed to a practice change of targeted early extubation in all patients post CV bypass. Despite an increased number of patients in the placebo group with TOF < 0.9 prior to extubation (suggesting quantitative residual weakness), there was no difference observed in clinical outcomes evaluated. Further studies are required to correlate quantitative NMB monitoring with signs and symptoms of rNMB in cardiac ICU patients.