Background: Preliminary clinical trials of adamgammadex, a new cyclodextrin-based selective reversal agent, havedemonstrated its efficacy in reversing neuromuscular block by rocuronium. 

Methods: This multicentre, randomised, double-blind, positive-controlled, non-inferiority phase III clinical trialcompared the efficacy and safety of adamgammadex and sugammadex. We randomised 310 subjects to receive adamgammadex (4 mg kg-1) or sugammadex (2 mg kg-1) at reappearance of the second twitch of the train-of-four (TOF), andstandard safety data were collected. 

Results: For the primary outcome, the proportion of patients with TOF ratio ≥0.9 within 5 min was 98.7% in theadamgammadex group vs 100% in the sugammadex group, with a point estimate and 95% confidence interval (CI) of 1.3%(-4.6%, +1.3%); the lower limit was greater than the non-inferiority margin of e10%. For the key secondary outcome, the median (inter quartile range) time from the start of administration of adamgammadex or sugammadex to recovery ofTOF ratio to 0.9 was 2.25 (1.75, 2.75) min and 1.75 (1.50, 2.00) min, respectively. The difference was 0.50 (95% CI: 0.25, 0.50); the upper limit was lower than the non-inferiority margin of 5 min. In addition, there were no inferior results observed insecondary outcomes. Adamgammadex had a lower incidence of adverse drug reactions compared with sugammadex(anaphylactic reaction, recurarisation, decreased heart rate, and laryngospasm; P= 0.047).

Conclusions: Adamgammadex was non-inferior to sugammadex with a possible lower incidence of adverse drug reactions compared with sugammadex. Adamgammadex may have a potential advantage in terms of its overallriskebenefit profile.

四川大學(xué)華西醫(yī)院為該論文第一通訊單位。

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