Reversal of Neuromuscular Blockade

The study is being conducted to evaluate the safety and tolerability of HRS-2162 injection in a single dose in healthy subjects, as well as the characteristics of PK/PD

Safety during modern practice of anaesthesia is of great concern. Patients admitted daily for surgical procedures undergoing general anaesthesia for different types of operations are exposed to different risks, starting from the anaesthesia and ending with the surgical intervention. Aim of the study is to provide a comprehensive and evidence based data regarding the safety of the neuromuscular blocking agents used in modern anaesthesia practice, precisely Rocuronium and Pipecuronium, as well as the reversal agents such as Sugammadex, which is the sole agent in use in practice nowadays. A routine anaesthetic practice will be performed during the whole period of our study after strict patient selection criteria. Intraoperative standard monitoring as per local and international guidelines will be applied, this includes Spo2, ECG, NIBP/IBP, etCO2, BIS and Tetragaph for neuromuscular blockade monitoring. After induction of anaesthesia and prior to the administration of the muscle relaxant agent, a TOFC (Train of Four Count) will be registered as the starting point. Throughout the anaesthetic time, there will be continuous TOF monitoring. The anaesthesia will be maintained by sevoflurane. Also, the recruited samples will be divided according to the neuromuscular blockade agents administered, either Rocuronium or Pipecuronium. At the end of the surgical procedure, the time lapse between the administration of the reversal agent Sugammadex and a TOF ratio of 0.9 is registered as our primary end point. TOF measures will be performed in the postoperative period, to make sure there is no residual neuromuscular blockade in the early postoperative phase. The study will not only monitor the safety of the neuromuscular blocking agents in use, but will also monitor any signs of anaphylaxis due to their administration both intra and postoperatively.

In operating procedure with general anesthesia muscle relaxant is usually used to increase success rate of the operation and to give better outcome. The use of reversal drugs aims to reduce the risk of post-operative complications due to muscle relaxants. Neostigmine is commonly used as a reversal drug, but its indirect mechanism of action results in a long and unpredictable recovery time. Sugammadex directly bind and inactivate rocuronium, in which resulting in a faster and predictable recovery time. However, the high price limits the use of sugammadex. This study aims to compare the effect of half dose sugammadex and neostigmine against the moderate neuromuscular blockade of rocuronium. The main questions it aims to answer are: Does half dose sugammadex gives faster recovery time? Researchers will compare sugammadex to neostigmine to see if sugammadex gives faster recovery time. Participants will: Be given sugammadex or neostigmine as a reversal drug after the operation done