International journal of obstetric anesthesia · 2026
Plasma levels and postpartum breastmilk concentrations of sugammadex: a pharmacokinetic study in women undergoing general anaesthesia for caesarean delivery.
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Hodge A T, Tognolini A R, Liu X, Won H, Roberts J A, Wallis S C, Woods C A, Eley V A
Аннотация
BACKGROUND: Pregnancy is associated with altered pharmacokinetics for many drugs. We aimed to describe the pharmacokinetics of sugammadex, including breastmilk excretion, in pregnant women having caesarean delivery under general anaesthesia at term.
METHODS: During general anaesthesia for scheduled caesarean delivery, pregnant patients were given rocuronium at induction of anaesthesia, and sugammadex for reversal of neuro-muscular block. Blood, urine and breastmilk were sampled for up to 24 h following the administration of sugammadex. The total plasma concentrations of rocuronium and sugammadex were measured using liquid chromatography-mass spectrometry. Monolix was used for population pharmacokinetic analysis.
RESULTS: Ten patients were recruited with a mean 30 ± 6.3 years, median [IQR] weight 78.0 [68.5, 99.8] kg, body mass index 28.9 [26.7, 37.7] kg/m2, and four (40%) were nulliparous. Sixty-six rocuronium and 65 sugammadex plasma concentrations were used to develop a two-compartment model for sugammadex and the rocuronium-sugammadex complex. Rocuronium volume of distribution was 17.9 L and clearance 12.6 L/h. Sugammadex volume of distribution was 13.9 L and clearance 8.0 L/h. Sugammadex was detected in only 12.5% of breastmilk samples up to six hours but in each sample was below the limit of quantification.
CONCLUSIONS: The volume of distribution and clearance of rocuronium and sugammadex were at the upper end of published ranges from non-pregnant patients. Sugammadex was not detected or was below the lower limit of quantification in all breastmilk samples, providing reassurance regarding infant exposure in the early post-partum period.
METHODS: During general anaesthesia for scheduled caesarean delivery, pregnant patients were given rocuronium at induction of anaesthesia, and sugammadex for reversal of neuro-muscular block. Blood, urine and breastmilk were sampled for up to 24 h following the administration of sugammadex. The total plasma concentrations of rocuronium and sugammadex were measured using liquid chromatography-mass spectrometry. Monolix was used for population pharmacokinetic analysis.
RESULTS: Ten patients were recruited with a mean 30 ± 6.3 years, median [IQR] weight 78.0 [68.5, 99.8] kg, body mass index 28.9 [26.7, 37.7] kg/m2, and four (40%) were nulliparous. Sixty-six rocuronium and 65 sugammadex plasma concentrations were used to develop a two-compartment model for sugammadex and the rocuronium-sugammadex complex. Rocuronium volume of distribution was 17.9 L and clearance 12.6 L/h. Sugammadex volume of distribution was 13.9 L and clearance 8.0 L/h. Sugammadex was detected in only 12.5% of breastmilk samples up to six hours but in each sample was below the limit of quantification.
CONCLUSIONS: The volume of distribution and clearance of rocuronium and sugammadex were at the upper end of published ranges from non-pregnant patients. Sugammadex was not detected or was below the lower limit of quantification in all breastmilk samples, providing reassurance regarding infant exposure in the early post-partum period.