Stabilité physico-chimique des solutions injectables de bésilate de cisatracurium dans les conditions cliniques d’utilisation

Pignard, J.; Bourdeaux, Daniel; Kauffmann, S.; Constantin, J.-M.; Sautou, V.

doi:10.1016/j.annfar.2014.03.009

Cited by 4 publications

(8 citation statements)

References 7 publications

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“…Among the current clinical anesthetics, both cisatracurium besylate and mivacurium chloride are good choices, and each has its own advantages. For example, the former has a remarkable muscle relaxation effect [22], while the latter is associated with fewer side reactions [23]. Currently, it remains controversial which is more effective.…”

Section: Discussionmentioning

confidence: 99%

Comparative Analysis of the Anesthesia Effect of Cisatracurium Besylate and Mivacurium Chloride Otolaryngology Surgery

Shi-bin

2022

Evidence-Based Complementary and Alternative Medicine

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Objective. The aim is to investigate and compare the anesthesia effect of cisatracurium besylate and mivacurium chloride otolaryngology surgery. Materials and Methods. 108 patients who underwent ENT surgery under general anesthesia in our hospital from November 2021 to March 2022 were recruited for retrospective analysis, in which patients in the experimental group A were anesthetized with cisatracurium besylate and patients in the experimental group B were anesthetized with mivacurium, and the anesthetic effects and recovery of the two groups were compared and analyzed. Results. There was no significant difference in mean arterial pressure, heart rate, and pulse oximetry levels between the two groups at the six time points of admission, anesthesia induction, intubation, end of operation, recovery of consciousness, and extubation (all P > 0.05 ). The train of four stimulation values at end of operation, recovery of consciousness, and extubation were significantly higher than those of the experimental group A (all P > 0.05 ). The recovery time of self-consciousness, extubation time, and eye-opening time of the experimental group B were significantly shorter than those of the experimental group A, and the occurrence of agitation was significantly less than that of the experimental group A (all P > 0.05 ). The total incidence of adverse conditions in the experimental group B was significantly lower than that in the experimental group A ( P > 0.05 ). Conclusion. Compared with cisatracurium besylate in otolaryngology surgery, mivacurium chloride anesthesia offers a promising route with respect to less impact on hemodynamics, faster postoperative recovery, absence of the accumulation of neuromuscular blockade, less adverse reactions, and higher safety.

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Section: Discussionmentioning

confidence: 99%

Comparative Analysis of the Anesthesia Effect of Cisatracurium Besylate and Mivacurium Chloride Otolaryngology Surgery

Shi-bin

2022

Evidence-Based Complementary and Alternative Medicine

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“…Our results confirmed previous reports on cisatracurium degradation. However, in contrast to the outcomes of forced degradation assays in vitro, we found that the ester hydrolysis pathway was more active than the Hofmann elimination pathway at 2 to 8 °C; this raises the question of whether laudanosine should be used as the sole marker of cisatracurium degradation in stability studies [ 18 ]. A stability study of cisatracurium solutions stored at room temperature might usefully complement the present work because the degradation pathways might differ from those observed here at between 2 and 8 °C.…”

Section: Discussionmentioning

confidence: 92%

“…To the best of our knowledge, the present study is the first to have demonstrated that a refrigerated cisatracurium solution can be stable for more than 90 days [ 17 , 18 ].…”

Section: Resultsmentioning

confidence: 99%

“…There are no specific literature data on the toxicity of cisatracurium’s DPs other than laudanosine. Given that cisatracurium’s DPs do not have neuromuscular blocking activity [ 18 ], we considered that semi-quantitative monitoring was sufficient for DPs other than laudanosine. According to the USP monograph on cisatracurium besylate injection, the acceptance criteria for DPs is 4% of the cisatracurium (base) area for laudanosine, 4.3% for cis-quaternary acid (EP impurity A [ 26 ]), 5% for cis-quarternary alcohol (EP impurity F [ 26 ]), 2.5% for cis-monoacrylate (EP impurity O [ 26 ]), and 14.4% for total DPs [ 15 ].…”

Section: Methodsmentioning

confidence: 99%

“…Xu et al studied 2 and 10 mg/mL solutions and found that when stored in glass vials, the drug was stable for at least 45 days at 23 °C and for at least 90 days at 4 °C [ 17 ]. When stored in polypropylene syringes, 2 mg/mL cisatracurium solutions were reportedly being stable for at least 30 days at both 4 °C and 23 °C (according to Xu et al [ 17 ]) or at least 7 days at both 5 °C and 25 °C (according to Pignard et al [ 18 ]), and 5 mg/mL solutions were reportedly stable for at least 7 days at both 5 °C and 25 °C [ 18 ]. However, there are no literature data on the stability of 10 mg/mL cisatracurium solutions for injection stored in amber glass ampoules at 2 to 8 °C for more than 90 days.…”

Section: Introductionmentioning

confidence: 99%

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Cistracurium Besylate 10 mg/mL Solution Compounded in a Hospital Pharmacy to Prevent Drug Shortages: A Stability Study Involving Four Degradation Products

Roche,

Danel,

Simon

et al. 2023

Pharmaceutics

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Background: Stability study of a 10 mg/mL injectable cisatracurium solution stored refrigerated in amber glass ampoules for 18 months (M18). Methods: 4000 ampoules were aseptically compounded using European Pharmacopoeia (EP)-grade cisatracurium besylate, sterile water for injection, and benzenesulfonic acid. We developed and validated a stability-indicating HPLC-UV method for cisatracurium and laudanosine. At each stability study time point, we recorded the visual aspect, cisatracurium and laudanosine levels, pH, and osmolality. Sterility, bacterial endotoxin content, and non-visible particles in solution were checked after compounding (T0) and after M12 and M18 of storage. We used HPLC-MS/MS to identify the degradation products (DPs). Results: During the study, osmolality remained stable, pH decreased slightly, and the organoleptic properties did not change. The number of non-visible particles remained below the EP’s threshold. Sterility was preserved, and bacterial endotoxin level remained below the calculated threshold. Cisatracurium concentration remained within the ±10% acceptance interval for 15 months and then decreased to 88.7% of C0 after M18. The laudanosine generated accounted for less than a fifth of the cisatracurium degradation, and three DPs were generated—identified as EP impurity A, impurities E/F, and impurities N/O. Conclusion: Compounded 10 mg/mL cisatracurium injectable solution is stable for at least 15 months.

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Farmacología de los curares

Haberer

2017

EMC - Anestesia-Reanimación

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Stabilité physico-chimique des solutions injectables de bésilate de cisatracurium dans les conditions cliniques d’utilisation

Cited by 4 publications

References 7 publications

Comparative Analysis of the Anesthesia Effect of Cisatracurium Besylate and Mivacurium Chloride Otolaryngology Surgery

Comparative Analysis of the Anesthesia Effect of Cisatracurium Besylate and Mivacurium Chloride Otolaryngology Surgery

Cistracurium Besylate 10 mg/mL Solution Compounded in a Hospital Pharmacy to Prevent Drug Shortages: A Stability Study Involving Four Degradation Products

Farmacología de los curares

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