ENHANCED RECOVERY AFTER CARDIAC SURGERY – USE OF SUGAMMADEX VS NEOSTIGMINE: A RANDOMIZED CONTROLLED TRIAL

Cardiac surgical patients account for a vast majority of the high-risk perioperative population. Enhanced Recovery After Surgery (ERAS) are multidisciplinary perioperative pathways designed to reduce surgical insult, prevent healthcare-associated complications, and hasten patient recovery through the bundled application of evidence-based measures. With the advancement of newer drugs and improved techniques in cardiac anaesthesia and surgery, the application of ERAS pathways in cardiac surgery is possible but clear evidence-based protocols for the use of ERAS in cardiac surgical patients are still lacking.

Neostigmine, an acetylcholinesterase inhibitor, has classically been the neuromuscular blockade reversal agent in all patient groups. Sugammadex is a gamma-cyclodextrin drug and is FDA approved for neuromuscular paralysis reversal after surgery. It rapidly reverses neuromuscular block by encapsulating the nondepolarizing aminosteroid paralysing agents like rocuronium and vecuronium. We aim to conduct a single-center, randomized, double-arm prospective study involving adult patients undergoing open heart surgeries to evaluate the use of sugammadex in applying ERAS protocol in cardiac surgery by comparing the time to extubation and other postoperative recovery parameters upon using Sugammadex vs the standard reversal agent, Neostigmine.

After Institutional Ethics Committee permission, we propose to conduct a randomized controlled study over 4 months in 80 patients, aged 18-65 years American Society of Anaesthesiologist (ASA) physical status II - III undergoing elective open heart surgeries under general anaesthesia, and requiring rocuronium-induced neuromuscular blockade. Following ERAS protocols for cardiac surgery, the patients will be undergoing cardiac surgery and shifted intubated to ICU where they will be administered either Neostigmine (Group N) or Sugammadex (Group S). Thereafter, the postoperative recovery parameters will be assessed.

The data will be collected, compiled, and analyzed using SPSS version 25. The qualitative variables will be expressed in terms of percentages. The quantitative variables will be both categorized and expressed in terms of percentages or in terms of mean and standard deviations. The difference between the two groups will be analyzed using a student t test. The difference between the two proportions will be analyzed using chi-square or Fisher exact test. All analysis will be 2 tailed, and the significance level will be set at 0.05.