Efficacy and Safety of Sugammadex for the Reversal of Rocuronium-Induced Neuromuscular Blockade in Patients with End-Stage Renal Disease: A Systematic Review and Meta-Analysis

Medicina (Lithuania) - Tập 57 Số 11 - Trang 1259
Young Sung Kim1, Byung Gun Lim1, Young-Ju Won1, Seok Kyeong Oh1, Jung-Suk Oh1, Soo-Ah Cho1
1Department of Anaesthesiology and Pain Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul 08308, Korea

Tóm tắt

Background and Objectives: Sugammadex is widely used in anesthesia to reverse rocuronium-induced neuromuscular blockade (NMB). In patients with compromised kidney function, most drugs show alteration of their pharmacokinetic profile with reduced clearance. The purpose of this article is to examine the efficacy, pharmacokinetics, and safety of sugammadex in end-stage renal disease (ESRD) patients receiving general anesthesia, using a systematic review. Materials and Methods: The databases of PubMed, EMBASE, the Cochrane Library, Web of Science, Scopus, KoreaMed, and ClinicalTrials.gov were searched for studies comparing the efficacy or safety outcomes of sugammadex administration for the reversal of rocuronium-induced NMB, in ESRD patients (group R) or in those with normal renal function (group N) undergoing surgery under general anesthesia. Results: We identified nine studies with 655 patients—six prospective, case-control studies with 179 patients (89 and 90 in groups R and N) and three retrospective observational studies with 476 ESRD patients. In the six prospective studies, the times taken to reach a train-of-four ratio ≥0.9, 0.8, and 0.7 were significantly longer in group R than in group N (weighted mean difference [95% confidence interval] [min]: 1.14 [0.29 to 2.00], 0.9 [0.24 to 1.57], 0.89 [0.20 to 1.57], respectively). The total plasma clearance of sugammadex was significantly lower in group R than in group N. There was no significant difference in the incidence of NMB recurrence and prolonged time to recovery between the groups. In the three retrospective studies, the possibility of sugammadex-related adverse events appears to be insignificant. Conclusions: Sugammadex may effectively and safely reverse rocuronium-induced NMB in patients with ESRD, although the recovery to a TOF ratio of 0.9 may be prolonged compared to patients with normal renal function. Further studies are needed, considering the small number of studies included and the high heterogeneity of some of the results.

Từ khóa


Tài liệu tham khảo

Bom, 2002, A novel concept of reversing neuromuscular block: Chemical encapsulation of rocuronium bromide by a cyclodextrin-based synthetic host, Angew. Chem. Int. Ed. Engl., 41, 266

Staals, 2010, Reduced clearance of rocuronium and sugammadex in patients with severe to end-stage renal failure: A pharmacokinetic study, Br. J. Anaesth., 104, 31, 10.1093/bja/aep340

Epemolu, 2003, Reversal of neuromuscular blockade and simultaneous increase in plasma rocuronium concentration after the intravenous infusion of the novel reversal agent Org 25969, Anesthesiology, 99, 632, 10.1097/00000542-200309000-00018

Peeters, 2011, Sugammadex is cleared rapidly and primarily unchanged via renal excretion, Biopharm. Drug Dispos., 32, 159, 10.1002/bdd.747

U.S. Food and Drug Administration, and Merck Sharp & Dohme Corp. (2019, December 05). BRIDION® (Sugammadex) Injection, for Intravenous Use, Available online: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022225lbl.pdf.

Ono, 2018, Efficacy and safety of sugammadex in patients undergoing renal transplantation, JA Clin. Rep., 4, 56, 10.1186/s40981-018-0192-z

Adams, 2020, Short-term safety and effectiveness of sugammadex for surgical patients with end-stage renal disease: A two-centre retrospective study, Anaesthesia, 75, 348, 10.1111/anae.14914

Pfaff, 2019, Sugammadex for Reversal of Neuromuscular Blockade in a Patient With Renal Failure, J. Pediatr. Pharmacol. Ther., 24, 238

Higgins, J.P.T., Thomas, J., and Chandler, J. (2021, September 03). Cochrane Handbook for Systematic Reviews of Interventions, Available online: https://training.cochrane.org/handbook/archive/v6.

Sterne, 2016, ROBINS-I: A tool for assessing risk of bias in non-randomised studies of interventions, BMJ, 355, i4919, 10.1136/bmj.i4919

Tardelli, 2015, Efficacy and safety of sugammadex in the reversal of deep neuromuscular blockade induced by rocuronium in patients with end-stage renal disease: A comparative prospective clinical trial, Eur. J. Anaesthesiol., 32, 681, 10.1097/EJA.0000000000000312

Panhuizen, 2015, Efficacy, safety and pharmacokinetics of sugammadex 4 mg kg-1 for reversal of deep neuromuscular blockade in patients with severe renal impairment, Br. J. Anaesth., 114, 777, 10.1093/bja/aet586

Staals, 2008, Multicentre, parallel-group, comparative trial evaluating the efficacy and safety of sugammadex in patients with end-stage renal failure or normal renal function, Br. J. Anaesth., 101, 492, 10.1093/bja/aen216

Maeyama, 2014, Prolonged recovery time from muscle relaxation due to rocuronium in patients with severe chronic renal disease using sugammadex: 9AP4-6, Eur. J. Anaesthesiol. EJA, 31, 152, 10.1097/00003643-201406001-00431

Min, 2017, Pharmacokinetics of sugammadex in subjects with moderate and severe renal impairment, Int. J. Clin. Pharmacol. Ther., 55, 746

Paredes, 2020, Sugammadex use in patients with end-stage renal disease: A historical cohort study, Can. J. Anaesth., 67, 1789, 10.1007/s12630-020-01812-3

Magoon, 2021, Sugammadex in end-stage renal disease: Too early for a “free-pass”, Can. J. Anaesth., 68, 264, 10.1007/s12630-020-01860-9

Carlos, 2016, The use of rocuronium and sugammadex in paediatric renal transplantation: Two case reports, Eur. J. Anaesthesiol., 33, 383, 10.1097/EJA.0000000000000338

Kurita, 2016, Rocuronium-sugammadex use for electroconvulsive therapy in a hemodialysis patient: A case report, JA Clin. Rep., 2, 28, 10.1186/s40981-016-0055-4

Renew, 2021, In reply: Sugammadex in end-stage renal disease: Too early for a “free-pass”, Can. J. Anaesth., 68, 266, 10.1007/s12630-020-01861-8

Sparr, 2007, Early reversal of profound rocuronium-induced neuromuscular blockade by sugammadex in a randomized multicenter study: Efficacy, safety, and pharmacokinetics, Anesthesiology, 106, 935, 10.1097/01.anes.0000265152.78943.74

Sorgenfrei, 2006, Reversal of rocuronium-induced neuromuscular block by the selective relaxant binding agent sugammadex: A dose-finding and safety study, Anesthesiology, 104, 667, 10.1097/00000542-200604000-00009

Cammu, 2012, Dialysability of sugammadex and its complex with rocuronium in intensive care patients with severe renal impairment, Br. J. Anaesth., 109, 382, 10.1093/bja/aes207

Tercan, 2021, Nephroprotective Efficacy of Sugammadex in Ischemia-Reperfusion Injury: An Experimental Study in a Rat Model, Cureus, 13, e15726