Multicentre, parallel-group, comparative trial evaluating the efficacy and safety of sugammadex in patients with end-stage renal failure or normal renal function

Staals, Lonneke M.; Snoeck, M.M.J.; Driessen, J. J.; Flockton, E.; Heeringa, Marten; Hunter, Jennifer M.

doi:10.1093/bja/aen216

Cited by 139 publications

(104 citation statements)

References 22 publications

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“…Volume of distribution, renal plasma clearance and half-life of sugammadex are signifi cantly increased in this group of patients (15). In renal failure state, much longer elimination time of sugammadex plus rocuronium complex was found although Staals et al could not show any level of recurarization after 48 hours of sugammadex administration (16).…”

Section: Sugammadex and Postoperative Renal Adverse Eventsmentioning

confidence: 66%

The effects of low and high doses of sugammadex on kidney tissue in streptozotocin-induced diabetic rats

G¹,

Hc²,

Alkan³

et al. 2015

BLL

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BACKGROUND: Sugammadex is primarily excreted via renal route. We investigated effects of low and high doses of sugammadex (16 mg/kg versus 96 mg/kg) on renal tissue samples of streptozotocin-induced diabetic rats. MATERIAL AND METHODS: Twenty-four Wistar albino rats were divided into 4 groups. Group C (control -0.9 % NaCl), Group DC (diabetes control; 55 mg/kg streptozotocin, IP, only), Group DR-16S (diabetes-rocuronium -16 mg sugammadex, IV.) and Group DR-96S (diabetes-rocuronium -96 mg sugammadex, IV). Renal tissue histopathological evaluation and antioxidant status (measurements of MDA levels and NO activities) were studied. RESULTS: Signifi cantly higher levels of all infl ammation parameters (infl ammation, degeneration/necrosis, tubular dilatation, tubular cell degeneration, dilatation in Bowman's space, tubular hyaline casts, and lymphocyte infi ltration) were found in the 96 mg/kg sugammadex group. Higher MDA tissue levels and lower NO activity were found in the 96 mg/kg sugammadex group. DISCUSSION: We can conclude that high-dose (96 mg/kg) sugammadex administration resulted in signifi cant renal tissue damage in diabetic rats. As a consequence, low doses of sugammadex have to be preferred in diabetic patients (Tab. 2, Fig. 4, Ref. 26). Text in PDF www.elis.sk.

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Section: Sugammadex and Postoperative Renal Adverse Eventsmentioning

confidence: 66%

The effects of low and high doses of sugammadex on kidney tissue in streptozotocin-induced diabetic rats

G¹,

Hc²,

Alkan³

et al. 2015

BLL

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“…Studies that were performed about sugammadex are seen in patients diagnosed with terminal phase renal failure [10][11][12], cardiac disease [13], pulmonary disease [14]. It is suggested that sugammadex can be used in these patients more safely the results of these studies.…”

Section: Resultsmentioning

confidence: 99%

Side effects of sugammadex use in pediatric patients

Sarı

Taşdemir²,

Özkisacik³

et al. 2013

J Clin Exp Invest

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ÖZETAmaç: Sugammadeks'in diğer nöromuskuler blok antagonisti ajanlardan daha hızlı etki gösterdiği yapılan çalışmalarla kabul edilmektedir fakat özellikle pediatrik olgularda güvenilirlik, yan etkileri ile ilgili yapılan çalışma-ların sınırlı olduğu görülmektedir. Kliniğimizdeki pediatrik olgularda bir yıllık süredeki sugammadeks deneyimlerimizin yan etkileri bakımından olgu serisi olarak sunulması amaçlanmıştır. Yöntemler: Bir yıllık sürede Tıp Fakültesi ameliyathanesi, çocuk cerrahisi odasında genel anestezi altında sugammadeks uygulanmış olguların dosyaları ve intraoperatif anestezi kayıtları, postoperatif 24 saat ve postoperatif 24 saat sonrası kayıtları incelendi. Bulgular: İnfant (28 gün-23 ay) (n= 24), çocuk (2 yas-11 yas) (n= 16), adolesan (11-17 yas) (n=6) olmak üzere sugammadeks uygulanan toplam hasta sayısı 46 idi. Hastaların hiçbirisinde hipersensitivite bulgularına ve sugammadeks ile ilişkilendirilen istatistiksel anlamlı yan etkiye rastlanmadığı tespit edildi. Sonuç: Sugammadeks'in sahip olduğu özellikleri ile pediatrik hasta grubunda yeni kapılar açabileceğini düşün-mekteyiz. Fakat pediatrik hasta grubunda özellikle infantlarda güvenliği ile ilgili daha fazla dökümantasyona ihtiyaç vardır. Anahtar kelimeler: Sugammadeks, pediatrik hasta, yan etki ABSTRACT Objective: It is accepted that sugammadex show its effects more rapidly than the other neuromuscular block antagonists in many studies, however especially in pediatric cases, it is seen that about its reliability and side effects are limited in some studies. In our retrospective study, we aimed to present our experiences on sugammadex in terms of its side effects in the pediatric cases in our hospital for a 1-year period. Methods:The patient files and intraoperative anesthesia records, postoperative 24th hour and after postoperative 24th hour of the cases that underwent the application of sugammadex under general anesthesia in pediatric surgery operating room in a 1-year period were analyzed.Results: Totally 46 patients received sugammadex; infants (28 days-23 months) (n=24), children (2 years-11 years) (n=16) and adolescent (11-17 years) (n=6). None of the patients showed hypersensitivity and statistically significant side effects correlated to sugammadex. Conclusion:We think that sugammadex may open new doors in pediatric patient group with its features. However, more documentation is needed about the safety in pediatric patient group, particularly in infants. J Clin Exp Invest 2013; 4 (3): 265-268

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“…Therefore, at this time standard dosing continues to be based on weight and train of four twitches as outlined in the Hepatic metabolism is responsible for rocuronium and vecuronium clearance; renal clearance regulates the sugammadex-NMBA complex elimination. 10,[18][19][20][21][22][23][24] In healthy kidneys with a glomerular filtration rate (GFR) of 75-120 ml/min, 70% of the dose is excreted in six hours, and 80-90% in 24 hours. 21,25,26 In renal failure, with GFR <30ml/min, only 29% of the dose administered is cleared by 72 hours.…”

Section: Dosingmentioning

confidence: 99%

“…24 The use of high-flux dialysis removes the bound sugammadex, but at this time sugammadex administration is not recommended for patients with severe renal dysfunction. 16,18,23,24 clinicAl ApplicAtions Sugammadex has many advantages when compared to the administration of neostigmine or no reversal agent at all. On average, dose-dependent intravenous administration of sugammadex results in full reversal of NMB within three minutes, even in circumstances of deep neuromuscular block, and avoids the possibility of recurarization.…”

Section: Dosingmentioning

confidence: 99%

Sugammadex: A neuromuscular blockade agent encapsulator

Hurtado

2017

The Chronicles

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Multicentre, parallel-group, comparative trial evaluating the efficacy and safety of sugammadex in patients with end-stage renal failure or normal renal function

Abstract: Sugammadex administered at reappearance of T(2) rapidly and effectively reverses NMB induced by rocuronium in renal failure and healthy patients. Sugammadex was well tolerated by all patients. Further safety studies on sugammadex in patients with severe renal impairment are warranted.

Cited by 139 publications

References 22 publications

The effects of low and high doses of sugammadex on kidney tissue in streptozotocin-induced diabetic rats

The effects of low and high doses of sugammadex on kidney tissue in streptozotocin-induced diabetic rats

Side effects of sugammadex use in pediatric patients

Sugammadex: A neuromuscular blockade agent encapsulator

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