Comparison of the Efficacy and Safety of Adamgammadex with Sugammadex for Reversal of Rocuronium-Induced Neuromuscular Block: Results of a Phase II Clinical Trial

Yingying Jiang,Yujun Zhang,Zhaoqiong Zhu, Yidan Huang, Dachun Zhou,Jingchen Liu, Chaoyu Li,Xiangdong Chen, Dingxin Kang, Shoushi Wang,Jin Liu,Bin Liu,Wensheng Zhang

Journal of Clinical Medicine(2022)

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摘要
This current phase II clinical trial was to compare the effect and safety of adamgammadex, a new cyclodextrin-based selective relaxant binding agent, with sugammadex to reverse rocuronium-induced neuromuscular block. Patients were randomised to receive adamgammadex (4 or 6 mg kg−1) or sugammadex (2 mg kg−1, as a positive control group) at the reappearance of the second twitch (T2) in response to TOF stimulation. The standard safety data were collected. The 4 mg kg−1 (n = 16) and 6 mg kg−1 (n = 20) adamgammadex- and 2 mg kg−1 (n = 20) sugammadex-induced recovery time of TOF ratio to 0.9 were 2.3, 1.6, and 1.5 min, respectively (p = 0.49). The 4 mg kg −1 adamgammadex-induced median recovery time was longer than that of 2 mg kg−1 sugammadex (p = 0.01), and there was no difference between the 6 mg kg −1 adamgammadex group and 2 mg kg−1 sugammadex group (p = 0.32). Then, the number of patients who experienced adverse events (AEs) was 6, 11, and 14 for adamgammadex at 4, 6 mg kg−1 and sugammadex at 2 mg kg−1, respectively. The treatment emergent AEs that occurred more than twice were detailed as follows: incision site pain, hypotension, emesis, fever, throat pain, blood bilirubin increase, abnormal T-wave of ECG, dizziness, incision site swelling, postoperative fever, expectoration, and nausea. For drug-related AEs, the increased urine acetone bodies and first-degree atrioventricular block were observed in two patients from sugammadex group. Then, the previously reported AEs were not observed in this study, including anaphylaxis, haemorrhage, recurarization, abnormal basic vital signs, or lengthened QRS intervals and QT intervals. Adamgammadex was found to be effective for reversal of rocuronium-induced neuromuscular block as sugammadex.
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关键词
Cilostazol,Hypoxia/reoxygenation,Actin cytoskeleton,Adherens junction proteins,Tight junction proteins
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