Evaluation of the Toxicity of Sugammadex in Zebrafish Larvae

Abstract

Background: Sugammadex is a new neuromuscular blockade reversal agent. Recently, it has been used in patients under general anesthesia. However, sugammadex could be toxic to fetuses and pediatric patients under 3 years of age. In this study, we demonstrated the safety of sugammadex in fetuses, using zebrafish larvae. Furthermore, its neurotoxicity was evaluated using neuronal cell lines. Methods: We used SH-SY5Y cells to determine the viability of neuronal cells treated with sugammadex. Zebrafish larvae were used to determine the teratogenic effects of sugammadex. Results: Sugammadex showed no adverse effects on neuronal cells and zebrafish larvae. The survival rates of neuronal cells were not different in all concentrations. In addition, the heart formation of zebrafish embryos, which were exposed to various concentrations of sugammadex, were not different. Conclusion: This study demonstrated the feasibility of using sugammadex during pregnancy. However, further clinical studies will be required to extrapolate these results to humans.

The influence of different sugammadex doses on neural tube development in early‐stage chick embryos

“…Sugammadex has been in clinical practice since 2008, was approved by the United States Food and Drug Administration (U.S. FDA) in 2015, and has been widely used thereafter (Kim et al, 2020; Perinatology, 2019). It provides a higher level of safety and efficacy than pyridostigmine or neostigmine, when used to antagonize the muscle relaxation effects caused by steroid non‐depolarizing neuromuscular blocking agents (Buyukfirat et al, 2018; Kim et al, 2020; Richardson & Raymond, 2020; Shin, 2021; Yang & Keam, 2009).…”

“…Sugammadex has been in clinical practice since 2008, was approved by the United States Food and Drug Administration (U.S. FDA) in 2015, and has been widely used thereafter (Kim et al, 2020; Perinatology, 2019). It provides a higher level of safety and efficacy than pyridostigmine or neostigmine, when used to antagonize the muscle relaxation effects caused by steroid non‐depolarizing neuromuscular blocking agents (Buyukfirat et al, 2018; Kim et al, 2020; Richardson & Raymond, 2020; Shin, 2021; Yang & Keam, 2009). Sugammadex has also been found to be effective in a variety of clinical settings, including geriatric patients, children over 3 years of age, and patients with comorbidities (Carron et al, 2018; Hristovska et al, 2018; Kim et al, 2020; Liu et al, 2017; Pfaff et al, 2019; Plaud et al, 2009).…”

“…Raymond, 2020; Shin, 2021;Yang & Keam, 2009). Sugammadex has also been found to be effective in a variety of clinical settings, including geriatric patients, children over 3 years of age, and patients with comorbidities (Carron et al, 2018;Hristovska et al, 2018;Kim et al, 2020;Liu et al, 2017;Pfaff et al, 2019;Plaud et al, 2009). But its administration in pregnant women, fetuses and pediatric patients less than 3 years of age has raised questions (Kim et al, 2020).…”

“…Sugammadex has also been found to be effective in a variety of clinical settings, including geriatric patients, children over 3 years of age, and patients with comorbidities (Carron et al, 2018;Hristovska et al, 2018;Kim et al, 2020;Liu et al, 2017;Pfaff et al, 2019;Plaud et al, 2009). But its administration in pregnant women, fetuses and pediatric patients less than 3 years of age has raised questions (Kim et al, 2020). The U.S. FDA replaced the letter categories with a narrative risk summary of the maternal and fetal risks based on available human, animal, and pharmacologic data and implemented a new pregnancy lactation labeling rule (PLLR) in 2015 (Administration, 2014;Whyte, 2016).…”

“…It accelerates neuromuscular blockade reversal, and significantly reduces the risk of residual neuromuscular paralysis during general anesthesia (Chandrasekhar et al, 2023). Very little is known about the use of sugammadex in pregnant women, and there is not enough information in the literature to assess the drug's safety during early pregnancy and fetal development (Chandrasekhar et al, 2023; Kim et al, 2020; Perinatology, 2019; Richardson & Raymond, 2020; Shin, 2021).…”