Br J Anaesth. 2020 Feb;124(2):154-163. doi: 10.1016/j.bja.2019.10.016. Epub 2019 Nov 30.
Comparison of incidence of anaphylaxis between sugammadex and neostigmine: a retrospective multicentre observational study.
Orihara M1, Takazawa T2, Horiuchi T1, Sakamoto S1, Nagumo K1, Tomita Y3, Tomioka A4, Yoshida N5, Yokohama A6, Saito S7.
Author information
Abstract
BACKGROUND:
Although cases of anaphylaxis caused by sugammadex have been reported, its incidence remains uncertain. Conversely, no studies have evaluated the incidence of anaphylaxis to neostigmine.
METHODS:
This was a retrospective multicentre observational study of patients who underwent surgery under general anaesthesia between 2012 and 2016 to compare the incidence of anaphylaxis with sugammadex with that of neostigmine at four tertiary hospitals in Japan. To ensure the quality of diagnosis, only cases with a clinical history suggestive of anaphylaxis, along with positive results from in vitro or in vivo testing, were assessed.
RESULTS:
From a total of 49 532 patients who received general anaesthesia included in this study, 18 cases of anaphylaxis were reported, of which six were attributable to sugammadex and none to neostigmine. There were no fatalities attributable to anaphylaxis. The incidence of anaphylaxis caused by all drugs or by sugammadex was calculated as 0.036% (95% confidence interval [CI]: 0.022-0.057%) and 0.02% (of the number of sugammadex cases) (95% CI: 0.007-0.044%), respectively.
CONCLUSIONS:
The results suggest that neostigmine might be safer than sugammadex when assessing only the incidence of anaphylaxis. We believe that there is room for reconsideration of the choice of reversal agent for neuromuscular blocking agents by all anaesthetists.
CLINICAL TRIAL REGISTRATION:
UMIN000022365; UMIN000033561.
Copyright © 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.
KEYWORDS:
anaphylaxis; basophil activation test; neostigmine; neuromuscular blocking agents; skin tests; sugammadex
PMID: 31791621 DOI: 10.1016/j.bja.2019.10.016
Free full text
Similar articles
Publication type
Select item 319821122.
Br J Anaesth. 2020 Jan 22. pii: S0007-0912(20)30008-8. doi: 10.1016/j.bja.2020.01.003. [Epub ahead of print]
Anaphylaxis to sugammadex: should we be concerned by the Japanese experience?
Savic L1, Savic S2, Hopkins PM3.
Author information
KEYWORDS:
adverse drug reaction; drug hypersensitivity; neuromuscular blocking agent; perioperative anaphylaxis; sugammadex
PMID: 31982112 DOI: 10.1016/j.bja.2020.01.003
Similar articles
Publication type
Select item 318081513.
Anaesthesia. 2019 Dec 5. doi: 10.1111/anae.14897. [Epub ahead of print]
Reversal of neuromuscular blockade with sugammadex during continuous administration of anaesthetic agents: a double-blind randomised crossover study using the bispectral index.
Le Guen M1, Roussel C1, Chazot T1, Dumont GA2, Liu N1, Fischler M1.
Author information
Abstract
Sugammadex, a specific reversal agent for steroidal neuromuscular blocking drugs, has on occasion been reported to be associated with clinical signs of awakening. We performed a study to systematically search for an increase in bispectral index values and signs of awakening in patients maintained under general anaesthesia following sugammadex administration. Patients, scheduled to receive general anaesthesia with neuromuscular blockade, were included in this double-blind randomised crossover study. After surgery was completed, and while the train-of-four ratio was zero, intravenous anaesthesia was continued with the aim of maintaining the bispectral index in the range of 40-60. Patients then received either sugammadex 4 mg.kg-1 or saline. In cases of incomplete reversal of neuromuscular blockade after 5 min, patients received the other drug. Bispectral index and train-of-four monitoring were recorded every minute and clinical signs of awakening noted. Fifty-one patients completed the study. Median (IQR [range]) bispectral index values increased after sugammadex administration from 49 (43-53 [38-64]) to 63 (53-80 [45-97]) (p < 0.01) with an increase of ≥ 20 in 22 patients; 14 (27%) patients had clinical signs of awakening. Saline had no effect on bispectral index values, clinical signs of awakening or degree of neuromuscular blockade. This study confirms that reversal of neuromuscular blockade with sugammadex may be associated with clinical signs of awakening despite maintenance of anaesthesia. Intravenous anaesthesia should be maintained until complete recovery of muscle function is achieved, especially when sugammadex is administered.
© 2019 Association of Anaesthetists.
KEYWORDS:
BIS values; anaesthetic depth; neuromuscular blockade; sugammadex
PMID: 31808151 DOI: 10.1111/anae.14897
Similar articles
Select item 316190264.
Korean J Anesthesiol. 2019 Oct 17. doi: 10.4097/kja.19344. [Epub ahead of print]
Anaphylaxis induced by sugammadex and sugammadex- rocuronium complex: A case report.
Choi S1, Han S1, Kwak J1, Lee J1.
Author information
Abstract
BACKGROUND:
In sugammadex-induced anaphylaxis, sugammadex and/or sugammadex- rocuronium complex have possible allergenic epitope.
CASE:
We report a case of sugammadex-induced anaphylaxis during general anesthesia in a 60-year-old male undergoing orthopedic hand surgery, manifesting as profound hypotension and urticaria. The timing of onset was closely associated with sugammadex administration. The patient recovered after extensive therapy including fluid, epinephrine, other vasopressors, steroid, and antihistamine administration. By intradermal skin test which was done at 4 weeks after anaphylaxis, we confirmed positive reactions to both sugammadex and sugammadex- rocuronium complex.
CONCLUSIONS:
This is a rare case of sugammadex-induced anaphylaxis that both sugammadex and sugammadex- rocuronium complex were confirmed as allergenic epitopes.
KEYWORDS:
Anaphylaxis; Rocuronium; Skin test; Sugammadex
PMID: 31619026 DOI: 10.4097/kja.19344
Free full text
Similar articles
Select item 315849185.
Anesth Analg. 2019 Oct;129(4):1124-1129. doi: 10.1213/ANE.0000000000004207.
Retrospective Analysis of the Safety and Efficacy of Sugammadex Versus Neostigmine for the Reversal of Neuromuscular Blockade in Children.
Gaver RS1, Brenn BR, Gartley A, Donahue BS.
Author information
Abstract
BACKGROUND:
Sugammadex, with its novel mechanism of action of encapsulation and noncompetitive binding of aminosteroid neuromuscular-blocking agents (rocuronium and vecuronium), may offer distinct advantage to pediatric patients where residual neuromuscular blockade may be poorly tolerated. Data describing its use in the pediatric population are limited, and no large-scale studies are available evaluating the occurrence of adverse event across the full spectrum of ages. We sought to measure the occurrence of adverse events, assess the severity and clinical significance of the events, and quantify a surrogate measure of efficacy of sugammadex compared to neostigmine in a large population and in the full age range of children.
METHODS:
Beginning in September 2016 through initiation of data collection, we identified from our data warehouse that all patients were treated with sugammadex for reversal of neuromuscular blockade, from birth through adolescence, and retrospectively matched, by case type and age group, to historical neostigmine-treated controls. From subsequent chart review, we quantified occurrence of adverse events and administration of medications to treat adverse events. All cases in the originally identified cohort treated with epinephrine after administration of sugammadex underwent chart review to elicit the cause, in the event that an infrequently occurring event was not captured after the case-matching process. "End-Interval Time," the time from administration of reversal agent to time out of the procedure room, was measured as an indirect assessment of efficacy.
RESULTS:
Fewer cases of bradycardia were observed in the sugammadex group compared to the neostigmine group in the overall cohort (P < .001) and in the subgroups of older children (P < .001) and adolescents (P < .001). End-interval time, the time measured from administration of neuromuscular blockade (NMB) reversal agent to time out of the operating room, was significantly shorter in sugammadex-treated groups in the overall cohort (mean difference, 2.8; 95% CI, 1.85-3.77; P < .001) and all age groups except for first year (31 days through 12 months). This observation was most pronounced in the neonatal subgroup (mean difference, 11.94 minutes; 95% CI, 4.79-19.1; P < .001). No other adverse events measured were found to be different between treatment groups.
CONCLUSIONS:
This study provides data supporting the safe and effective use of sugammadex for reversal of neuromuscular blockade throughout the entire range of ages in the pediatric population. Within age groups, sugammadex demonstrates faster completion of operation compared with neostigmine, with the greatest difference observed in the neonatal population.
PMID: 31584918 DOI: 10.1213/ANE.0000000000004207
Similar articles
Select item 315456686.
Anesth Prog. 2019 Fall;66(3):151-155. doi: 10.2344/anpr-66-01-07.
Two Cases of Rocuronium-Induced Anaphylaxis/Anaphylactic Shock Successfully Treated With Sugammadex.
Hashimoto M1, Sato Boku A1,2,3, Tachi N1, Okumura Y1, Kadoi K1, Harada J1, Okuda M1.
Author information
Abstract
While anaphylaxis can occur at any time during general anesthesia, 90% of cases occur at induction of anesthesia. As several drugs are administered simultaneously at this time, it is difficult to identify the causative agent. However, it has been found that rocuronium is the most common drug associated with perioperative anaphylaxis. We treated 2 cases of patients who were administered sugammadex for anaphylactic symptoms thought to be caused by rocuronium, after which the anaphylactic symptoms disappeared. One of the most important aspects of treating anaphylactic shock is improving hemodynamics. If signs indicating circulatory collapse are observed, epinephrine should be administered immediately. However, because rocuronium was suspected of being the causative agent, and taking the patients' clinical course over time into consideration, sugammadex was initially administered. As a result, symptoms improved. Therefore, we believe that the administration of sugammadex may be effective for treating anaphylaxis caused by rocuronium and also help in identifying the causative agent.
KEYWORDS:
Anaphylactic shock; Epinephrine; Rocuronium; Sugammadex
PMID: 31545668 PMCID: PMC6759648 [Available on 2020-03-01] DOI: 10.2344/anpr-66-01-07
Similar articles
Select item 313598077.
Expert Opin Drug Saf. 2019 Oct;18(10):883-891. doi: 10.1080/14740338.2019.1649393. Epub 2019 Aug 7.
Safety of sugammadex for reversal of neuromuscular block.
Honing G1, Martini CH1, Bom A2, van Velzen M1, Niesters M1, Aarts L1, Dahan A1, Boon M1.
Author information
Abstract
Introduction: Sugammadex is a modified cyclodextrin that is able to reverse neuromuscular block induced by aminosteroidal neuromuscular blocking drugs. Compared to reversal with neostigmine, it reverses neuromuscular block quicker and more predictable and without cholinergic side effects. However, there have been concerns about sugammadex ability to bind other drugs and its effects on QT interval and clotting times. In addition, sugammadex might induce hypersensitivity reactions more frequently than initially anticipated. This review summarizes current evidence with regard to these and other safety aspects of sugammadex. Areas covered: This review provides an overview of the efficacy of sugammadex in various patient populations, evaluates potential interactions with other drugs and discusses adverse effects and reactions that have been reported in the literature. Expert opinion: Sugammadex quickly reverses aminosteroid neuromuscular block with less side effects compared to neostigmine. As such, it has the potential to significantly reduce the incidence of residual neuromuscular block and to improve postoperative pulmonary outcome. Current safety concerns mainly focus on hypersensitivity reactions and cardiac arrhythmias. Although the absolute risk for these events is low, ongoing vigilance and research in this area are needed.
KEYWORDS:
Expert opinion; neuromuscular blockade reversal; rocuronium safety evaluation; sugammadex
PMID: 31359807 DOI: 10.1080/14740338.2019.1649393
[Indexed for MEDLINE]
Similar articles
Publication types, MeSH terms, Substances
Select item 304819488.
Korean J Anesthesiol. 2019 Oct;72(5):495-499. doi: 10.4097/kja.d.18.00232. Epub 2018 Nov 27.
Anaphylactic shock after sugammadex administration, induced by formation of a sugammadex-rocuronium complex -a case report.
Kim GH1, Choi WS1, Kim JE1, Yun MJ1, Koo MS1, Kwon M1, Seo H2.
Author information
Abstract
BACKGROUND:
Sugammadex is a reversal agent for non-depolarizing neuromuscular blockers and widely used worldwide on account of its rapid and effective reversal from neuromuscular blockade, despite its advantages, multiple cases of sugammadex-induced anaphylactic shock have been reported.
CASE:
A 42-year-old man developed anaphylactic shock in the postanesthesia care unit. Initially, sugammadex was suspected as the causative agent, but an intradermal skin test revealed negative results. A further skin test was performed with sugammadex-rocuronium complex that yielded positive results.
CONCLUSIONS:
Anesthesiologists and healthcare providers should be aware of the possibility of anaphylaxis from the sugammadex-rocuronium complex, as well as from sugammadex or rocuronium alone.
KEYWORDS:
Anaphylactic shock; Cyclodextrin; Epinephrine; Hypersensitivity; Rocuronium; Sugammadex
PMID: 30481948 PMCID: PMC6781209 DOI: 10.4097/kja.d.18.00232
Free PMC Article
Similar articles
Publication type
Select item 314009739.
Transplant Proc. 2019 Sep;51(7):2265-2267. doi: 10.1016/j.transproceed.2019.03.051. Epub 2019 Aug 7.
Retrospective Investigation of Grafted Kidney Function After Reversal of Neuromuscular Blockade Using Neostigmine or Sugammadex.
Arslantas R1, Cevik BE2.
Author information
Abstract
INTRODUCTION:
Sugammadex has the steroid-encapsulating effect that reverses neuromuscular block induced by aminosteroid neuromuscular-blocking agents. Sugammadex can interact with other drugs that have the same steroidal structure with rocuronium, such as corticosteroids. Corticosteroids play a crucial role in the immunosuppression of kidney transplantation. The purpose of this study was to determine if there are any differences in grafted kidney function in recipients of kidney transplantation when sugammadex or neostigmine is given to the recipient.
METHODS:
The study included 42 recipients of kidney transplant, with complete, readable medical charts and anesthetic records. Fourteen recipients' neuromuscular block was reversed with sugammadex (group S) and 28 recipients' neuromuscular block was reversed with neostigmine (group N). We tested noninferiority for serum creatinine during the preoperative period and 5 days after transplantation. Short-term (28 days) outcomes of kidney transplantations were assessed by the incidence of acute rejection episodes, graft failure, length of stay at hospital, and mortality.
RESULTS:
There were no significant differences in demographic characteristics, serum creatinine values, short-term outcomes, and graft survival rates at 28 days' postoperatively between group S and group N (P > .05).
CONCLUSIONS:
Our data showed no difference in risk of serious adverse effects on short-term graft functions in patients who underwent kidney transplantation. However, considering the sugammadex-corticosteroids interaction, the immunosuppression and long-term effects on grafted kidney functions, current safety experience is insufficient to support the recommendation of routine sugammadex use in this population. These results need to be confirmed by sufficiently powered, controlled, pharmacokinetic, and pharmacodynamic studies on larger patient populations.
Copyright © 2019 Elsevier Inc. All rights reserved.
PMID: 31400973 DOI: 10.1016/j.transproceed.2019.03.051
[Indexed for MEDLINE]
Similar articles
Publication type, MeSH terms, Substances
Select item 3168238710.
Sugammadex for the Reversal of Neuromuscular Blockade in Surgical Patients: A Review of Clinical Effectiveness and Cost-Effectiveness [Internet].
Editors
Brett K, Farrah K.
Source
Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Aug.
CADTH Rapid Response Reports.
Excerpt
In many procedures requiring intubation neuromuscular blocking agents are administered during anesthesia to facilitate the intubation of the trachea and to optimize the surgical field.1 For short procedures (e.g., less than 30 minutes), a short acting neuromuscular blocking agent, such as succinylcholine, is required for rapid sequence induction and intubation.1 Succinylcholine, a depolarizing neuromuscular blocking agent, produces a reliable neuromuscular block (NMB), has the fastest onset and the shortest duration of all neuromuscular blocking agents, and the recovery of the NMB typically occurs by spontaneous recovery.1 Alternatives to succinylcholine may include using a longer acting neuromuscular blocking agent in conjunction with a reversal agent to produce a short-term NMB. Rocuronium is a non-depolarizing neuromuscular blocking agent with fast onset, which can be used at higher doses for rapid sequence induction and intubation.1 Sugammadex is a selective relaxant binding agent indicated for the reversal of moderate to deep NMB,2 with a high affinity for rocuronium.1,3 A manufacturer shortage of succinylcholine occurred in Canada in May 2019, and at the time this report was written, the drug shortage was anticipated to last until mid-August 2019.4 In these circumstances, the use of rocuronium with sugammadex may be an alternative to succinylcholine when there is a need for short acting NMB. Neuromuscular blocking agents and reversal agents are associated with various adverse effects, including residual NMB, myalgias, muscle fasciculations, headache, nausea, and vomiting,1,3 and it is unclear how the clinical benefits and harms of using rocuronium with sugammadex compare with using succinylcholine alone. In addition, the cost of sugammadex is significantly higher than other common reversal agents (e.g., neostigmine), and it is unknown if sugammadex is cost effective for routine clinical use.5 The purpose of this report is to synthesize and critically appraise the available evidence on the clinical effectiveness of rocuronium with sugammadex compared to succinylcholine in patients undergoing surgery who require rapid sequence induction. Additionally, the cost-effectiveness of sugammadex in patients undergoing surgery will be reviewed. This information may be used to inform decision making relating to health policy of the use of sugammadex.
Copyright © 2019 Canadian Agency for Drugs and Technologies in Health.
Sections
PMID: 31682387
Free Books & DocumentsFree full text
Similar articles
Sugammadex for the Reversal of Neuromuscular Blockade in Surgical Patients: A Review of Clinical Effectiveness and Cost-EffectivenessFree full text
Select item 3072053511.
A A Pract. 2019 Jul 1;13(1):17-19. doi: 10.1213/XAA.0000000000000973.
Efficacy of Sugammadex in Preventing Skin Test Reaction in a Patient With Confirmed Rocuronium Anaphylaxis: A Case Report.
Binczak M1, Fischler M1,2, Le Guen M1,2.
Author information
Abstract
The curative role of sugammadex has been challenged in several observations of rocuronium-induced anaphylaxis because sugammadex may not completely encapsulate the molecule of rocuronium. In such conditions, rocuronium remains able to cause immunoglobulin E cross-linkage and the anaphylaxis mechanism can continue. We describe a case of rocuronium-induced anaphylaxis in which clinical improvement followed sugammadex administration. Intradermic skin tests confirmed rocuronium immunoglobulin E-mediated anaphylaxis but also showed intradermal injection of mixing in equal molecular ratio of sugammadex with rocuronium preventing rocuronium anaphylactic skin reaction. This observation demonstrates the efficacy of sugammadex to prevent rocuronium interaction with the skin immune system.
PMID: 30720535 DOI: 10.1213/XAA.0000000000000973
[Indexed for MEDLINE]
Similar articles
Publication type, MeSH terms, Substances
Select item 3096191512.
Br J Anaesth. 2019 Jul;123(1):e144-e150. doi: 10.1016/j.bja.2019.03.001. Epub 2019 Apr 5.
Assessing cross-reactivity to neuromuscular blocking agents by skin and basophil activation tests in patients with neuromuscular blocking agent anaphylaxis.
Li J1, Best OG2, Rose MA3, Green SL3, Fulton RB4, Capon MJ3, Krupowicz BA3, Fernando SL5.
Author information
Abstract
BACKGROUND:
Following diagnosis of neuromuscular blocking agent (NMBA) anaphylaxis, identifying safe alternatives for subsequent anaesthesia is critical. A patient with anaphylaxis to one NMBA can also have an allergic reaction to other NMBAs (cross-reactivity). Whilst drug provocation testing is standard for identifying or excluding allergy, there is significant risk. In vitro, after an allergen activates basophils, basophils express surface activation markers that can be measured by basophil activation testing (BAT). We compared cross-reactivity between NMBAs assessed by BAT against that by skin testing.
METHODS:
All patients attending an anaesthetic allergy clinic in Sydney, Australia between May 2017 and July 2018 diagnosed with NMBA anaphylaxis qualified for this study comparing intradermal skin tests and BAT with a panel of NMBAs (rocuronium, vecuronium, pancuronium, suxamethonium, cisatracurium).
RESULTS:
Of the 61 patients participating, sensitisation on skin testing and on BAT completely matched in only nine patients (15%). Sensitisation was not in agreement for pancuronium, cisatracurium and rocuronium, but was in agreement for vecuronium and suxamethonium. Nine patients with negative skin tests subsequently tolerated cisatracurium, and one false positive on BAT to cisatracurium was detected.
CONCLUSIONS:
The utility of BAT in identifying safe NMBAs for subsequent anaesthesia needs further evaluation. BAT detects a different cross-reactivity profile to skin tests. Negative skin testing and BAT might increase confidence in performing drug provocation testing, but this and follow-up of subsequent anaesthesia in our cohort is necessary to determine the clinical significance of BAT sensitisation.
Copyright © 2019 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.
KEYWORDS:
anaphylaxis; basophil degranulation test; drug hypersensitivity; neuromuscular blocking agents; skin tests
PMID: 30961915 DOI: 10.1016/j.bja.2019.03.001
[Indexed for MEDLINE]
Similar articles
MeSH terms, Substance
Select item 3095423813.
Br J Anaesth. 2019 Jul;123(1):e135-e143. doi: 10.1016/j.bja.2019.02.024. Epub 2019 Apr 4.
Integrating basophil activation tests into evaluation of perioperative anaphylaxis to neuromuscular blocking agents.
Li J1, Best OG2, Rose MA3, Green SL3, Fulton RB4, Fernando SL5.
Author information
Abstract
BACKGROUND:
Neuromuscular blocking agents (NMBAs) remain the leading cause of perioperative anaphylaxis in Australia. Standard evaluation comprises history, skin tests, and in vitro specific immunoglobulin E tests. Drug provocation tests to suspected NMBA culprits are associated with a significant risk. Basophil activation testing (BAT) is a potentially useful in vitro test that is not commercially available in Australia or as part of standard evaluation.
METHODS:
All patients attending the Anaesthetic Allergy Clinic in Sydney, Australia between May 2017 and July 2018 exposed to an NMBA before the onset of anaphylaxis during their anaesthetic qualified for the study. We recruited 120 patients sequentially who received standard evaluation plus BAT using CD63, CD203c, and CD300a as surface activation markers.
RESULTS:
BAT results were expressed as % upregulation above the negative control and stimulation index (mean fluorescence index of stimulated sample divided by the negative control). We calculated cut-offs of 4.45% and 1.44 for CD63, and 8.80% and 1.49 for CD203c, respectively. Sensitivity was 77% with specificity of 76%. A subgroup of 10 patients with NMBA anaphylaxis had no sensitisation on skin tests. BAT using CD63 and CD203c showed sensitisation in six of these 10, and adding CD300a identified sensitisation in nine patients. BAT was positive in seven of nine patients with anaphylaxis of unknown aetiology.
CONCLUSIONS:
BAT may be a useful supplement to the standard evaluation in diagnosing NMBA anaphylaxis in patients with suggestive histories, but no sensitisation on skin tests. Ongoing study of this specific group of patients is required to clarify its utility in clinical practice.
Copyright © 2019 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.
KEYWORDS:
anaestehsia; anaphylaxis; basophil degranulation test; drug hypersensitivity; neuromuscular blocking agents; skin tests
PMID: 30954238 DOI: 10.1016/j.bja.2019.02.024
[Indexed for MEDLINE]
Similar articles
MeSH terms, Substance
Select item 3091601514.
Br J Anaesth. 2019 Jul;123(1):e16-e28. doi: 10.1016/j.bja.2019.01.027. Epub 2019 Mar 4.
Comparative epidemiology of suspected perioperative hypersensitivity reactions.
Mertes PM1, Ebo DG2, Garcez T3, Rose M4, Sabato V2, Takazawa T5, Cooke PJ6, Clarke RC7, Dewachter P8, Garvey LH9, Guttormsen AB10, Hepner DL11, Hopkins PM12, Khan DA13, Kolawole H14, Kopac P15, Krøigaard M16, Laguna JJ17, Marshall SD14, Platt PR7, Sadleir PHM18, Savic LC19, Savic S20, Volcheck GW21, Voltolini S22.
Author information
Abstract
Suspected perioperative hypersensitivity reactions are rare but contribute significantly to the morbidity and mortality of surgical procedures. Recent publications have highlighted the differences between countries concerning the respective risk of different drugs, and changes in patterns of causal agents and the emergence of new allergens. This review summarises recent information on the epidemiology of perioperative hypersensitivity reactions, with specific consideration of differences between geographic areas for the most frequently involved offending agents.
Copyright © 2019. Published by Elsevier Ltd.
KEYWORDS:
antibiotics; blood products; chlorhexidine; latex; neuromuscular blocking agents; perioperative anaphylaxis; perioperative hypersensitivity; sugammadex
PMID: 30916015 DOI: 10.1016/j.bja.2019.01.027
[Indexed for MEDLINE]
Similar articles
Publication type, MeSH terms
Select item 3093416015.
Paediatr Anaesth. 2019 Jun;29(6):591-596. doi: 10.1111/pan.13643. Epub 2019 Apr 29.
Case series of 331 cases of sugammadex compared to neostigmine in patients under 2 years of age.
Franz AM1, Chiem J1, Martin LD1, Rampersad S1, Phillips J2, Grigg EB1.
Author information
Abstract
BACKGROUND:
Sugammadex is a novel neuromuscular blockade reversal agent approved by the Food and Drug Administration in 2015, but little literature exists for patients less than 2 years of age.
AIMS:
The aims of this study were to: describe a cohort of patients 2 years old and younger who received sugammadex; describe any adverse effects of sugammadex in this age group; compare time from end of surgery to out of operating room for sugammadex versus neostigmine; compare time between last dose of neuromuscular blocking drug and reversal; and use train-of-four data to assess reversal.
METHODS:
Chart review of the medical record and the anesthesia information system captured all patients in this age cohort who received sugammadex or neostigmine over a two-year period. Adverse medication events were pulled from a mandatory quality improvement field in the electronic anesthesia record. T-tests were used for analyses.
RESULTS:
No adverse effects were reported with 331 doses of sugammadex. The average time in minutes between end of surgery and out of operating room was similar for neostigmine (19.6) versus sugammadex (19.4) (mean difference 0.2, 95% CI -1.5-1.8, P = 0.85). The average time in minutes between last dose of neuromuscular blocking drug and reversal agent was longer for neostigmine (103) than for sugammadex (84) (mean difference 19, 95% CI 13-26, P < 0.001).
CONCLUSIONS:
Sugammadex administration in this young population did not result in any adverse effects. It appears to be equally effective as neostigmine in patients under 2 years of age.
© 2019 John Wiley & Sons Ltd.
KEYWORDS:
adverse effects; anesthesia; neostigmine; neuromuscular blockade; pediatrics; sugammadex
PMID: 30934160 DOI: 10.1111/pan.13643
Similar articles
Select item 3039145516.
J Clin Anesth. 2019 May;54:48-49. doi: 10.1016/j.jclinane.2018.10.017. Epub 2018 Nov 2.
Anaphylaxis caused by sugammadex- rocuronium inclusion complex: What is the basis of the allergenic recognition?
Baldo BA1.
Author information
KEYWORDS:
Anaphylaxis; Drug allergenic determinants; Drug allergy; Rocuronium; Rocuronium-sugammadex complex; Sugammadex
Comment on
A suspected case of coronary vasospasm induced by anaphylactic shock caused by rocuronium-sugammadex complex. [J Clin Anesth. 2018]
PMID: 30391455 DOI: 10.1016/j.jclinane.2018.10.017
[Indexed for MEDLINE]
Similar articles
Publication types, MeSH terms, Substances
Select item 3127611417.
Turk J Anaesthesiol Reanim. 2019 Feb;47(1):69-72. doi: 10.5152/TJAR.2019.21298. Epub 2019 Feb 1.
Treatment of Anaphylaxis to Rocuronium with Sugammadex: A Case Report with Bronchospasm as the Only Symptom.
De La Cruz I1, Errando C1, Calaforra S2.
Author information
Abstract
Anaphylaxis during anaesthesia is a rare event occurring in up to 1:20,000 anaesthetics and in 33%-63% neuromuscular blocking agents are involved. Several case reports suggested the effectiveness of sugammadex in the treatment of rocuronium-induced anaphylactic shock refractory to conventional treatment. We report a case of anaphylactic reaction to rocuronium that caused isolated respiratory symptoms and showed no improvement in oxygen saturation after intravenous corticosteroids and intratracheal beta-2 agonists and that was successfully treated with sugammadex. The underlying pathophysiological mechanisms that explain the potential beneficial effect of sugammadex in this context are not completely known. We briefly review the literature regarding this topic.
KEYWORDS:
Anaphylaxis; rocuronium; sugammadex
PMID: 31276114 PMCID: PMC6598661 DOI: 10.5152/TJAR.2019.21298
Free PMC Article
Similar articles
Conflict of interest statement
Publication type
Select item 3089962218.
Cureus. 2019 Jan 12;11(1):e3871. doi: 10.7759/cureus.3871.
Anaphylaxis Induced by Sugammadex in a Patient with Papillary Serous Carcinoma of the Uterine Adnexa Undergoing Exploratory Laparotomy.
Escher AR Jr1, Cohen JB1.
Author information
Abstract
In this case report, we present a patient who developed anaphylaxis immediately after sugammadex administration. A 67-year-old female with the diagnosis of papillary serous carcinoma was scheduled for an exploratory laparotomy exam under anesthesia and total abdominal hysterectomy. At the end of the operation, sugammadex was administered; it was rapidly accompanied with marked hypotension and bradycardia. Multiple boluses of phenylephrine were administered with minimal effect. Boluses of epinephrine and vasopressin were given and the patient's hemodynamic instability rapidly abated. A 12-lead electrocardiogram (ECG) obtained in the post-anesthesia care unit (PACU) showed sinus tachycardia and a prolonged corrected QT (QTc) interval. A tryptase level was drawn in the operating room. After an uneventful PACU stay, the patient was observed overnight in the intensive care unit (ICU) as a precaution. Cardiology service was consulted, and they agreed with the anesthesia team that the cause of the patient's hemodynamic instability collapse was consistent with the diagnosis of anaphylaxis. The serum tryptase returned with a level of 62.3 ng/mL, confirming the diagnosis. The patient was discharged on postoperative Day 4. Anaphylaxis may result from sugammadex usage, and this might cause severe hypotension and cardiac arrhythmias. The prompt recognition and treatment of hypotension and anaphylaxis are critical to minimize morbidity and prevent mortality in these patients.
KEYWORDS:
adrenaline; adverse drug reactions; anaphylaxis; arrhythmia; epinephrine; hypotension; iatrogenic anaphylaxis; medication allergy; sugammadex; tryptase
PMID: 30899622 PMCID: PMC6414298 DOI: 10.7759/cureus.3871
Free PMC Article
Similar articles
Conflict of interest statement
Publication type
Select item 3023623819.
Br J Anaesth. 2018 Oct;121(4):758-767. doi: 10.1016/j.bja.2018.05.057. Epub 2018 Jul 13.
Sugammadex hypersensitivity and underlying mechanisms: a randomised study of healthy non-anaesthetised volunteers.
de Kam PJ1, Nolte H1, Good S1, Yunan M1, Williams-Herman DE1, Burggraaf J2, Kluft C3, Adkinson NF4, Cullen C1, Skov PS5, Levy JH6, van den Dobbelsteen DJ7, van Heumen ELGM7, van Meel FCM7, Glassner D1, Woo T1, Min KC8, Peeters PAM7.
Author information
Abstract
BACKGROUND:
We investigated potential for hypersensitivity reactions after repeated sugammadex administration and explored the mechanism of hypersensitivity.
METHODS:
In this double-blind, placebo-controlled study (NCT00988065), 448 healthy volunteers were randomised to one of three arms to receive three repeat i.v. administrations of either sugammadex 4 mg kg-1, 16 mg kg-1, or placebo. Primary endpoint was percentage of subjects with hypersensitivity (assessed by an independent adjudication committee). Secondary endpoint of anaphylaxis was classified per Sampson and Brighton criteria. Exploratory endpoints included skin testing, serum tryptase, anti-sugammadex antibodies [immunoglobulin (Ig) E/IgG], and other immunologic parameters.
RESULTS:
Hypersensitivity was adjudicated for 1/148 (0.7%), 7/150 (4.7%), and 0/150 (0.0%) subjects after sugammadex 4 mg kg-1, 16 mg kg-1, and placebo, respectively. After sugammadex 16 mg kg-1, one subject met Sampson criterion 1 and Brighton level 1 (highest certainty) anaphylaxis criteria; two met Brighton level 2 criteria. After database lock it was determined that certain protocol deviations could have introduced bias in the reporting of hypersensitivity signs/symptoms in a subject subset. Objective laboratory investigations indicated that potential underlying hypersensitivity mechanisms were unlikely to have been activated; the results suggest that most of the observed hypersensitivity reactions were unlikely IgE/IgG-mediated.
CONCLUSION:
Dose-dependent hypersensitivity or anaphylaxis reactions to sugammadex were observed when administered without prior neuromuscular blocking agent. Laboratory investigations do not suggest prevalent allergen-specific IgE/IgG-mediated immunologic hypersensitivity. Because it could not be fully excluded that estimates of hypersensitivity/anaphylaxis incidence were unbiased, an additional study was conducted to characterise the potential for hypersensitivity reactions and is described in a companion report.
CLINICAL TRIAL REGISTRATION:
http://www.clinicaltrials.gov NCT00988065; Protocol number P06042.
Copyright © 2018 British Journal of Anaesthesia. All rights reserved.
KEYWORDS:
anaphylaxis; hypersensitivity; sugammadex
Comment in
Sugammadex: the sting in the tail? [Br J Anaesth. 2018]
PMID: 30236238 DOI: 10.1016/j.bja.2018.05.057
[Indexed for MEDLINE] Free full text
Similar articles
Publication type, MeSH terms, Substances
Select item 3023623720.
Br J Anaesth. 2018 Oct;121(4):749-757. doi: 10.1016/j.bja.2018.05.056. Epub 2018 Aug 23.
Hypersensitivity incidence after sugammadex administration in healthy subjects: a randomised controlled trial.
Min KC1, Bondiskey P2, Schulz V2, Woo T2, Assaid C2, Yu W3, Reynders T4, Declercq R4, McCrea J2, Dennie J2, Adkinson F5, Shepherd G6, Gutstein DE2.
Author information
Abstract
BACKGROUND:
We evaluated the incidence of hypersensitivity or anaphylaxis after repeated single-dose sugammadex administration in non-anaesthetised adults.
METHODS:
In this multicentre, double-blind study (NCT02028065), healthy volunteer subjects were randomised (2:2:1 ratio) to one of three groups to receive three repeated intravenous injections of sugammadex 4 or 16 mg kg-1, or placebo, separated by a ∼5 week intervals. Targeted hypersensitivity assessments were performed 0.5, 4, and 24 h post-dosing, and hypersensitivity signs/symptoms were referred to a blinded independent Adjudication Committee. Anaphylaxis was determined per Sampson (Criterion 1). The primary endpoint was the proportion with confirmed hypersensitivity.
RESULTS:
Of 375 evaluable subjects, 25 had confirmed hypersensitivity [sugammadex 4 mg kg-1: 10/151 (6.6%); sugammadex 16 mg kg-1: 14/148 (9.5%); placebo: 1/76 (1.3%)]. The differences in incidence rates vs placebo were 5.3% (95% confidence interval: -0.9, 10.7) for sugammadex 4 mg kg-1 and 8.1% (1.7, 14.2) for 16 mg kg-1. Incidence was similar across sugammadex doses and dosing occasions, including in subjects with reactions to previous doses. Three subjects (16 mg kg-1 group) required antihistamines/corticosteroids and discontinued the study, per protocol; symptoms resolved and no subject required epinephrine. One subject with anaphylaxis after the first 16 mg kg-1 dose recovered completely post-treatment. There were no clinically relevant anti-sugammadex antibody or tryptase findings.
CONCLUSIONS:
Hypersensitivity in response to sugammadex administration can occur in healthy subjects without history of previous sugammadex exposure. Hypersensitivity incidence was similar across sugammadex doses and numerically higher than placebo, with no evidence of sensitisation with repeated administration. Hypersensitivity is unlikely to be mediated through sugammadex-specific immunoglobulin G- or E-mediated mast cell stimulation in healthy volunteers.
CLINICAL TRIAL REGISTRATION:
NCT02028065.
Copyright © 2018 British Journal of Anaesthesia. All rights reserved.
KEYWORDS:
anaphylaxis; hypersensitivity; neuromuscular block; sugammadex
Comment in
Sugammadex: the sting in the tail? [Br J Anaesth. 2018]
PMID: 30236237 DOI: 10.1016/j.bja.2018.05.056
[Indexed for MEDLINE] Free full text
Similar articles
Publication types, MeSH terms, Substances
Δεν υπάρχουν σχόλια:
Δημοσίευση σχολίου