Reversal of rocuronium-induced neuromuscular blockade with sugammadex compared with neostigmine during sevoflurane anaesthesia: results of a randomised, controlled trial
ABSTRACT Sugammadex, a modified gamma-cyclodextrin, is a selective relaxant-binding agent designed to reverse the effects of the steroidal neuromuscular blocking agents rocuronium or vecuronium. This study compared the efficacy of sugammadex and neostigmine for reversal of neuromuscular blockade induced by rocuronium for facilitating elective surgery.
This randomised, multicentre, parallel-group trial included 98 adult patients. Patients received intravenous propofol for induction followed by sevoflurane maintenance anaesthesia. Neuromuscular blockade was monitored using acceleromyography and a train-of-four (TOF) mode of stimulation. Patients were randomly allocated to receive sugammadex 2.0 mg kg(-1) or neostigmine 50 microg kg (-1) (with glycopyrrolate 10 microg kg(-1)) at reappearance of the second response of the TOF (mean 16% twitch height of first response) after the last dose of rocuronium. Safety was evaluated by assessing adverse events, laboratory variables and vital signs.
Time to recovery of the TOF ratio of 0.9 after sugammadex compared with neostigmine was significantly shorter (P < 0.0001), being 1.5 versus 18.6 min (geometric means). Predictability of response was greater with sugammadex than neostigmine: with 98% of sugammadex patients versus 11% of neostigmine patients recovering to a TOF ratio of 0.9 within 5 min. There were no clinical events related to residual neuromuscular blockade or reoccurrence of blockade. Serious adverse events were observed in two sugammadex-treated patients and in three neostigmine-treated patients, respectively, but none were considered related to study drugs.
Sugammadex achieved significantly faster recovery of neuromuscular function after rocuronium to a TOF ratio of 0.9 compared with neostigmine (Clinicaltrials.gov identifier: NCT00451217).
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ABSTRACT: To determine whether the new selective binding agent sugammadex causes less postoperative nausea and vomiting (PONV) than the cholinesterase inhibitor neostigmine. Prospective, randomized, double-blinded study. University-affiliated hospital. One hundred American Society of Anesthesiologists physical status 1 and 2 patients scheduled for extremity surgery. Patients were randomly assigned to neostigmine (70 μg/kg) and atropine (0.4 mg per mg neostigmine) or sugammadex 2 mg/kg for neuromuscular antagonism at the end of anesthesia, when 4 twitches in response to train-of-four stimulation were visible with fade. We recorded PONV, recovery parameters, antiemetic consumption, and side effects. Nausea and vomiting scores were lower in the sugammadex patients upon arrival in the postanesthesia care unit (med: 0 [min-max, 0-3] vs med: 0 [min-max, 0-3]; P < .05), but thereafter low and comparable. Postoperative antiemetic and analgesic consumption were similar in each group. Extubation (median [interquartile range], 3 [1-3.25] vs 4 [1-3.25]; P < .001) first eye opening (4 [3-7.25] vs 7 [5-11]; P < .001), and head lift (4 [2-7.25] vs 8 [11-25]; P < .001) in minutes were shorter in patients given sugammadex. Postoperative heart rates were significantly lower in all measured times patients given neostigmine. Nondepolarizing neuromuscular blocking antagonism with sugammadex speeds recovery of neuromuscular strength but only slightly and transiently reduces PONV compared with neostigmine and atropine. Copyright © 2014 Elsevier Inc. All rights reserved.Journal of Clinical Anesthesia 12/2014; 27(1). DOI:10.1016/j.jclinane.2014.08.010 · 1.21 Impact Factor
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ABSTRACT: Background. Sugammadex offers a good alternative to the conventional decurarisation process currently performed with cholinesterase inhibitors. Sugammadex, which was developed specifically for the aminosteroid-structured rocuronium and vecuronium neuromuscular blockers, is a modified cyclodextrin made up of 8 glucose monomers arranged in a cylindrical shape. Methods. In this study, the goal was to investigate the efficacy of sugammadex. Sugammadex was used when there was insufficient decurarisation following neostigmine. This study was performed on 14 patients who experienced insufficient decurarisation (TOF <0.9) with neostigmine after general anaesthesia in the operating rooms of a university and a state hospital between June, 2012, and January, 2014. A dose of 2 mg/kg of sugammadex was administered. Results. Time elapsed until sugammadex administration following neostigmine 37 ± 6 min, following sugammadex it took 2.1 ± 0.9 min to reach TOF ≥0.9, and the extubation time was 3.2 ± 1.4 min. No statistically significant differences were detected in the hemodynamic parameters before and after sugammadex application. From the time of administration of sugammadex to the second postoperative hour, no side effects or complications occurred. None of the patients experienced acute respiratory failure or residual block during this time period. Conclusion. Sugammadex was successfully used to reverse rocuronium-induced neuromuscular block in patients where neostigmine was insufficient.BioMed Research International 01/2014; 2014:945310. DOI:10.1155/2014/945310 · 2.71 Impact Factor
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ABSTRACT: We aimed to compare clinical effects of sugammadex versus combination of anticholinergic-anticholinesterase agents for reversing of nondepolarizing neuromuscular block in pediatric patients. A total of 60 pediatric patients whom should be performed general anesthesia in the supine position were enrolled to this randomized double-blinded clinical trial. Fentanyl 1 μg/kg, propofol 2 mg/kg, rocuronium 0.6 mg/kg were used in induction and sevofluran, 50% O2-50% N2O in maintenance of anesthesia. Neuromuscular conductions were assessed by train of four (TOF)-Watch SX (Organon, Schering-Plough, Ireland) acceleromyograph. Patients were intubated at the moment of TOF 0. At the end of the operation emergence of T2 point was replied by 2 mg/kg sugammadex administration in group 1 and 0.06 mg/kg neostigmine +0.02 mg/kg atropine in group 2. At the moment of T0.9 inhalation, gases were ceased, and patients were extubated. Hemodynamic alterations, access to T0.9, extubation time, recovery parameters, drug consumptions and adverse effects were recorded. Train of four scores showed a lesser increase in group 2 than group 1 from 15(th) s to 30(th) min during post reverse period (from 6.9 ± 6.4 to 91.7 ± 7.2 in group 2 vs. from 35.4 ± 21.4 to 99.5 ± 1.0 in group 1) (p < 0.0004). Group 1 patients exhibited much more complete muscle strength rates than group 2 (P < 0.001). T0.9 and extubation times were significantly longer in group 2 than group 1 (P < 0.001). Comparison of adverse effects yielded no difference. Sugammadex can be considered as a safe agent in order to reverse neuromuscular block in pediatric patients.