Comparison of sugammadex and sugammadex combined with neostigmine for reversal of vecuronium induced neuromuscular blockade in patients undergoing general anaesthesia : A randomised clinical trial

The use of neuromuscular blocking agents during induction of anaesthesia, facilitates intubation and improve surgical access by providing muscle relaxation and maintaining deep neuromuscular blockade until the end of the operation. Rapid reversal of neuromuscular blockade at the end of surgery is desirable to enhance patient safety and to avoid post operative complications like residual neuromuscular blockade.

Sugammadex is a novel agent without cholinergic side effects that specifically binds to steroidal neuromuscular blocking agents like vecuronium and rocuronium, reversing their effects and thus, rapidly restoring neuromuscular function.  The use of sugammadex along with neostigmine can enhance neuromuscular recovery, thereby allowing for a lower dosage of sugammadex to be administered. By reducing the dosage of sugammadex, it can lower the overall cost of sugammadex while its efficacy is preserved.

Hence, in this study we want to compare sugammadex and sugammadex combined with neostigmine for reversal of vecuronium induced neuromuscular blockade in patients undergoing general anaesthesia. After obtaining ethical clearance and written informed consent, a total number of 120 patients between 18-60 years of ASA physical status I and II undergoing elective surgery under general anaesthesia in the Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur will be randomly divided into two groups of 60 each. Group A patients will receive sugammadex at a dose of 2 mg/kg and Group B patients will receive a combination of sugammadex 1 mg/kg with neostigmine 50 mcg/kg and glycopyrrolate 10 mcg/kg for reversal of vecuronium induced neuromuscular blockade when two twitches to train of four stimulation appear. After administration of reversal agent, the time taken from the start of administration of the study drugs to the appearance of second twitch of train of four stimulation till recovery of its normalised ratio of 0.9 will be compared between the two groups. Additionally, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), oxygen saturation (SpO2) and heart rate (HR) will be recorded. All the findings and observations made during the entire study will be recorded in a proforma, tabulated in the EXCEL software and statistically analysed using SPSS software. Inference will be drawn to evaluate and compare the study drugs along with their clinical advantages and adverse effects.