Table 1.

Gaps Between Theoretical Assumptions/preclinical Studies and Clinical Evidence

Clinical situations	Theoretical assumptions/preclinical studies	Clinical evidences
Cesarean section	Increased volume of distribution and clearance: different dosing may be needed.	May be effective and safe with adult dosing.
		16 mg/kg administration has never been reported but Difficult Airway Society guideline recommend to use high-dose of sugammadex when CICV occurred.
Non-obstetric surgery
Fetal development	Large and polarized molecule: limited placental transfer	Small clinical studies: no evidence of fetal developmental abnormalities.
	Conflicting results in preclinical studies:incomplete ossification, neuronal apoptosis.
Maintenance of pregnancy	Capturing and eliminating progesterone: failure to maintain pregnancy	Small clinical studies: no evidence of preterm labor, miscarriage or stillbirth.
Hormonal contraceptives	Capturing and eliminating progesterone: failure of hormonal contraceptives conflicting results in preclinical studies.	Small clinical studies: steroidal hormonal changes in human are insignificant and temporal.
		No clinical studies to confirm the causal relationship between unintended pregnancy and sugammadex.
Lactation	Large and polarized molecule: limited breast milk transfer	No clinical studies of the presence of sugammadex in human breast milk.
		Drug and Lactation Database says it may be safe.
	Preclinical study showed peak concentration in breast milk 30 min after sugammadex administration.	SOAP statement recommends to avoid it at term or near term pregnancy.
	Early in the postpartum period, gaps between the mammary alveolar cells increased and peak concentration of sugammadex may pass through breast milk.

CICV: cannot intubate and cannot ventilate, SOAP: Society of Obstetric Anesthesia, and Perinatology.