A randomized trial evaluating the safety profile of sugammadex in high surgical risk ASA physical class 3 or 4 participants

Table 5 Selected AEs of clinical interest up to 7 days post-treatment. All Participants as Treated

	n (%)	Difference in %^a (95% CI)
With ≥ ECIs^b
Neostigmine/glycopyrrolate, n = 51	2 (3.9)	(ref.)
Sugammadex 2 mg/kg, n = 105	2 (1.9)	−2.1 (− 11.8, 3.8)
Sugammadex 4 mg/kg, n = 107	6 (5.6)	1.8 (−8.1, 8.4)
Sugammadex 16 mg/kg, n = 68	5 (7.4)	1.1 (−13.5, 11.1)
Clinically Relevant Bradycardia
Neostigmine/glycopyrrolate, n = 51	1 (2.0)	(ref.)
Sugammadex 2 mg/kg, n = 105	0	−2.0 (−10.5, 1.6)
Sugammadex 4 mg/kg, n = 107	3 (2.8)	0.9 (− 7.8, 6.6)
Sugammadex 16 mg/kg, n = 68	0	− 3.1 (− 15.9, 2.4)
Clinically Relevant Tachycardia
Neostigmine/glycopyrrolate, n = 51	0	(ref.)
Sugammadex 2 mg/kg, n = 105	2 (1.9)	1.9 (−5.3, 6.8)
Sugammadex 4 mg/kg, n = 107	2 (1.9)	1.8 (− 5.4, 6.6)
Sugammadex 16 mg/kg, n = 68	4 (5.9)	5.9 (− 5.0, 14.3)
Other Clinically Relevant Cardiac Arrhythmia
Neostigmine/glycopyrrolate, n = 51	1 (2.0)	(ref.)
Sugammadex 2 mg/kg, n = 105	0	−2.0 (−10.5, 1.6)
Sugammadex 4 mg/kg, n = 107	1 (0.9)	−1.0 (− 9.5, 3.5)
Sugammadex 16 mg/kg, n = 68	1 (1.5)	−1.7 (− 14.6, 5.4)

^aDifferences are calculated using the stratified Miettinen and Nurminen method with NMBA and ASA Physical Class strata as factors. ^bNo AEs of adjudicated hypersensitivity, adjudicated anaphylaxis, or drug-induced liver injury were reported up to 7 days post-treatment; ASA American Society of Anesthesiologists, AE Adverse event, CI Confidence interval, ECI Events of clinical interest

ISSN: 1471-2253