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

Table 3 Summary of TE arrhythmias analyzed by ASA Physical Class stratum. All Participants as Treated

Treatment	ASA Physical Class 3			ASA Physical Class 4
Treatment	n (%)	Estimate (95% CI)	P-value	n (%)	Estimate (95% CI)	P-value
TE Sinus Bradycardia
Neostigmine/glycopyrrolate, n = 38^a, 13^b	2 (5.3)	(ref.)		2 (15.4)	(ref.)
Sugammadex 2 mg/kg, n = 79^a, 26^b	1 (1.3)	−4.0 (−16.2, 2.5)	0.202	0	−15.4 (− 42.6, − 0.9)	0.043
Sugammadex 4 mg/kg, n = 79^a, 28^b	1 (1.3)	− 4.0 (− 16.2, 2.5)	0.202	1 (3.6)	−11.8 (−39.6, 5.9)	0.182
Sugammadex 16 mg/kg, n = 51^a, 17^b	4 (7.8)	2.6 (− 10.5, 14.3)	0.633	1 (5.9)	−9.5 (− 38.1, 15.2)	0.398
TE Sinus Tachycardia
Neostigmine/glycopyrrolate, n = 38	7 (18.4)	(ref.)		4 (30.8)	(ref.)
Sugammadex 2 mg/kg, n = 79	5 (6.3)	−12.1 (−27.8, −0.3)	0.044	2 (7.7)	−23.1 (−51.7, 1.2)	0.063
Sugammadex 4 mg/kg, n = 79	10 (12.7)	−5.8 (− 22.1, 7.4)	0.409	0	−30.8 (− 57.9, − 12.5)	0.002
Sugammadex 16 mg/kg, n = 51	5 (9.8)	−8.6 (− 25.1, 5.9)	0.242	1 (5.9)	−24.9 (− 53.6, 2.8)	0.075
Other TE Cardiac Arrhythmias
Neostigmine/glycopyrrolate, n = 38	0	(ref.)		1 (7.7)	(ref.)
Sugammadex 2 mg/kg, n = 79	0	0.0 (−9.3, 4.7)	> 0.999	1 (3.8)	−3.8 (− 30.4, 13.0)	0.612
Sugammadex 4 mg/kg, n = 79	0	0.0 (−9.3, 4.7)	> 0.999	0	−7.7 (−33.7, 5.3)	0.142
Sugammadex 16 mg/kg, n = 51	0	0.0 (−9.3, 7.1)	> 0.999	1 (5.9)	−1.8 (− 29.0, 21.3)	0.846

^aNumber of participants in ASA Physical Class 3 stratum; ^bnumber of participants in ASA Physical Class 4 stratum; ASA American Society of Anesthesiologists, CI Confidence interval, TE Treatment-emergent

ISSN: 1471-2253