A Randomized Controlled Trial of Sugammadex versus Neostigmine for Reversal of Rocuronium on Gastric Emptying in Adults Undergoing Elective Colorectal Surgery.

Abstract

BACKGROUND Gastrointestinal function is mediated by the cholinergic pathway, which is impacted by neostigmine and glycopyrrolate, but not sugammadex. We hypothesized that sugammadex is associated with earlier gastric emptying in adults undergoing colorectal surgery, compared to neostigmine-glycopyrrolate. METHODS Patients were enrolled in a pragmatic, single-center, patient and assessor-blinded, randomized, controlled trial. At skin closure, subjects were randomized to sugammadex 2 mg/kg or neostigmine 0.07 mg/kg and glycopyrrolate (0.2 mg per 1 mg of neostigmine). The primary end point, gastric emptying, was assessed with the paracetamol absorption test, with greater area under the curve representing faster gastric emptying. Secondary end points included time to first bowel movement, time to achieve adequate reversal (train-of-four ratio ≥0.9), gastrointestinal complications, hospital length of stay, and postanesthesia care unit recovery time. The analysis was intention-to-treat. RESULTS All 60 patients randomized to sugammadex received the allocated intervention. Of 60 patients randomized to neostigmine-glycopyrrolate, 56 received neostigmine-glycopyrrolate, 2 received sugammadex, and 2 received both agents. Gastric emptying did not differ significantly between sugammadex (mean [standard deviation {SD}] area under the curve {AUC} 1118 [122]) and neostigmine (AUC 1130 [117], P = .58). Sugammadex treatment was associated with shorter time to first bowel movement (44.3 hours [33.8] vs 61.0 hours [43.0]; difference = 16.7 hours, 95% confidence interval {CI}, [2.3-31.1], P = .02) and time to adequate reversal (5.2 minutes [6.3] vs 17.5 minutes [10.1]; difference = 12.3 minutes, 95% CI, [9.2-15.4], P < .001). Neostigmine-glycopyrrolate treatment was not associated with a significant increase in gastrointestinal complications (32% vs 17%; OR = 2.3, 95% CI, [0.9-6.2], P = .09), a longer hospital length of stay (7.8 days [19.8] vs 4.8 days [4.9]; difference = 3 days, 95% CI, [-2.2 to 8.3], P = .27), or a difference in postanesthesia care unit recovery time (108 minutes [56.4] vs 115 minutes [50.3]; difference= -6.9 minutes, 95% CI, [-26.4 to 12.6], P = .48). Adverse events were similar between groups. CONCLUSIONS Sugammadex treatment was not associated with faster gastric emptying (primary end point). Regarding prespecified secondary end points, sugammadex treatment was associated with a 12.3-minute shorter time to adequate reversal in real-life practice conditions, but it did not benefit the proportion of subjects with a gastrointestinal complication, hospital length of stay, or postanesthesia care unit recovery time. Further studies are needed to confirm our finding that sugammadex is associated with a clinically significant 16.7-hour shorter time to first bowel movement, and to establish the role of sugammadex in colorectal surgery enhanced recovery protocols.