PMID- 36498526
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221221
IS  - 2077-0383 (Print)
IS  - 2077-0383 (Electronic)
IS  - 2077-0383 (Linking)
VI  - 11
IP  - 23
DP  - 2022 Nov 25
TI  - Comparison of the Efficacy and Safety of Adamgammadex with Sugammadex for 
      Reversal of Rocuronium-Induced Neuromuscular Block: Results of a Phase II 
      Clinical Trial.
LID - 10.3390/jcm11236951 [doi]
LID - 6951
AB  - 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 (T(2)) 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.
FAU - Jiang, Yingying
AU  - Jiang Y
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 
      610041, China.
AD  - National-Local Joint Engineering Research Center of Translational Medicine of 
      Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, China.
FAU - Zhang, Yujun
AU  - Zhang Y
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 
      610041, China.
AD  - National-Local Joint Engineering Research Center of Translational Medicine of 
      Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, China.
AD  - Laboratory of Anaesthesia and Critical Care Medicine, Translational Neuroscience 
      Center, West China Hospital, Sichuan University, Chengdu 610041, China.
FAU - Zhu, Zhaoqiong
AU  - Zhu Z
AD  - Department of Anesthesiology, The First Affiliated Hospital of Zunyi Medical 
      University, Zunyi 563000, China.
FAU - Huang, Yidan
AU  - Huang Y
AD  - Department of Anesthesiology, Liuzhou People's Hospital, Liuzhou 545000, China.
FAU - Zhou, Dachun
AU  - Zhou D
AD  - Department of Anesthesiology, Zhejiang University School of Medicine Sir Run Run 
      Shaw Hospital, Hangzhou 310000, China.
FAU - Liu, Jingchen
AU  - Liu J
AD  - Department of Anesthesiology, The First Affiliated Hospital of Guangxi Medical 
      University, Nanning 530021, China.
FAU - Li, Chaoyu
AU  - Li C
AD  - Department of Anesthesiology, The Second People's Hospital of Neijiang, Neijiang 
      641000, China.
FAU - Chen, Xiangdong
AU  - Chen X
AUID- ORCID: 0000-0003-3347-2947
AD  - Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan 430022, China.
FAU - Kang, Dingxin
AU  - Kang D
AD  - Department of Anesthesiology, The 2th Affiliated Hospital of WMU, Wenzhou 325000, 
      China.
FAU - Wang, Shoushi
AU  - Wang S
AD  - Department of Anesthesiology, Qingdao Central Hospital Group, Qingdao 266000, 
      China.
FAU - Liu, Jin
AU  - Liu J
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 
      610041, China.
AD  - National-Local Joint Engineering Research Center of Translational Medicine of 
      Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, China.
AD  - Laboratory of Anaesthesia and Critical Care Medicine, Translational Neuroscience 
      Center, West China Hospital, Sichuan University, Chengdu 610041, China.
FAU - Liu, Bin
AU  - Liu B
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 
      610041, China.
AD  - National-Local Joint Engineering Research Center of Translational Medicine of 
      Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, China.
AD  - Laboratory of Anaesthesia and Critical Care Medicine, Translational Neuroscience 
      Center, West China Hospital, Sichuan University, Chengdu 610041, China.
FAU - Zhang, Wensheng
AU  - Zhang W
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 
      610041, China.
AD  - National-Local Joint Engineering Research Center of Translational Medicine of 
      Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, China.
AD  - Laboratory of Anaesthesia and Critical Care Medicine, Translational Neuroscience 
      Center, West China Hospital, Sichuan University, Chengdu 610041, China.
LA  - eng
GR  - 2016ZX09101066/National Major Scientific and Technological Special Project for 
      "Significant New Drugs Development"/
PT  - Journal Article
DEP - 20221125
PL  - Switzerland
TA  - J Clin Med
JT  - Journal of clinical medicine
JID - 101606588
PMC - PMC9738056
OTO - NOTNLM
OT  - adamgammadex
OT  - muscle relaxant antagonist
OT  - perioperative medicine
OT  - pharmacodynamics
OT  - phase II clinical trial
OT  - sugammadex
COIS- The authors declare no conflict of interest.
EDAT- 2022/12/12 06:00
MHDA- 2022/12/12 06:01
PMCR- 2022/11/25
CRDT- 2022/12/11 01:13
PHST- 2022/11/03 00:00 [received]
PHST- 2022/11/19 00:00 [revised]
PHST- 2022/11/22 00:00 [accepted]
PHST- 2022/12/11 01:13 [entrez]
PHST- 2022/12/12 06:00 [pubmed]
PHST- 2022/12/12 06:01 [medline]
PHST- 2022/11/25 00:00 [pmc-release]
AID - jcm11236951 [pii]
AID - jcm-11-06951 [pii]
AID - 10.3390/jcm11236951 [doi]
PST - epublish
SO  - J Clin Med. 2022 Nov 25;11(23):6951. doi: 10.3390/jcm11236951.