Андрология и генитальная хирургия. 2020; 21: 30-37
Сравнительная характеристика анестезии с использованием оригинального и неоригинального препаратов севофлурана при урологических операциях у детей: результаты проспективного исследования
https://doi.org/10.17650/2070-9781-2020-21-3-30-37Аннотация
Цель исследования — оценить эффективность и безопасность применения оригинального и неоригинального препаратов севофлурана в ходе урологических операций у детей.
Материалы и методы. Пациенты урологического профиля в возрасте 3—6лет без коморбидной патологии перенесли оперативное вмешательство продолжительностью не более 40 мин под ингаляционной анестезией, для которой в 1-й группе (n = 11) применяли оригинальный севофлуран, во 2-й группе (n = 11) — неоригинальный севофлуран. Глубину анестезии оценивали по биспектральному индексу.
Результаты. У пациентов, получавших неоригинальный севофлуран, синдром возбуждения до начала анестезии и во вводном ее периоде наблюдался соответственно в 54,5 и 72,7 % случаев, реакция на установку ларингеальной маски — в 36,4 % случаев. Данные реакции отсутствовали у пациентов, получавших оригинальный севофлуран. Неоригинальный препарат вызывал более глубокое угнетение сознания; различия с группой оригинального препарата на 15-й и 20-й минутах достигали уровня статистической значимости: 44 (42; 46) против 50 (49; 54; р = 0,0001) и 42 (40; 46) против 50 (47; 56; р = 0,003) соответственно. Глубина анестезии при использовании неоригинального севофлурана была непостоянной, в отличие от таковой при применении оригинального препарата.
Заключение. Несмотря на одинаковую формулу оригинального и неоригинального препаратов севофлурана, неоригинальный препарат характеризуется большей частотой возникновения синдрома возбуждения и реакции на установку ларингеальной маски и непостоянной глубиной анестезии.
Список литературы
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22. Tomal C.R., Silva A.G., Yamashita A.M. et al. Assessment of induction, recovery, agitation upon awakening, and consumption with the use of two brands of sevoflurane for ambulatory anesthesia. Rev Bras Anesthesiol 2012;62(2):54—172. DOI: 10.1016/S0034-7094(12)70115-0.
23. Li Y., Li Y.C., Zhang Y.N. et al. Degradation products of different water content sevoflurane in carbon dioxide absorbents by gas chromatography-mass spectrometry analysis. Chin Med J (Engl) 2011;124(7):1050—4.
24. Kharasch E.D., Subbarao G.N., Cromack K.R. et al. Sevoflurane formulation water content influences degradation by Lewis acids in vaporizers. Anesth Analg 2009;108(6):1796—802. DOI: 10.1213/ane.0b013e3181a3d72b.
25. Baker M.T. Sevoflurane: are there differences in products? Anesth Analg 2007;104(6):1447—51. DOI: 10.1213/01.ane.0000263031.96011.36.
26. Byon H.J., Choi B.M., Bang J.Y. et al. An open-label comparison of a new generic sevoflurane formulation with original sevoflurane in patients scheduled for elective surgery under general anesthesia. Clin Ther 2015;37(4):887—901. DOI: 10.1016/j.clinthera.2015.01.012.
Andrology and Genital Surgery. 2020; 21: 30-37
Comparative characteristics of original and non-original sevoflurane in urological operations in children: a prospective study results
https://doi.org/10.17650/2070-9781-2020-21-3-30-37Abstract
The study objective is to evaluate the effectiveness and safety of the original and non-original sevoflurane during urological operations in children.
Materials and methods. Patients of urological profile 3—6 years old without comorbid pathology underwent surgery lasting no more than 40 min under inhalation anesthesia: in group 1 — original sevoflurane (n = 11), group 2 — non-original sevoflurane (n = 11). The depth of anesthesia was evaluated using bispectral index monitoring.
Results. In the group of non-original sevoflurane, the excitation syndrome before the beginning of anesthesia and in its introductory period was noted in 54.5 and 72.7 % respectively, the reaction to the introduction of a laryngeal mask — in 36.4 % of patients in the absence of these reactions in the group of the original drug. There was a higher depth of anesthesia in non-original drug with the achievement of statistically significant differences in the indicator at 15 and 20 min: 44 (42; 46) vs 50 (49; 54; p = 0.0001) and 42 (40; 46) vs 50 (47; 56; p = 0.003) respectively, as well unstable level of depth of anesthesia of the group of non-original sevoflurane compared to the original during the period of maintaining anesthesia.
Conclusion. Despite the same formula of the original and non-original sevoflurane, the non-original drug was characterized by a greater frequency of excitation syndrome and reaction to the introduction of a laryngeal mask and unstable depth of anesthesia.
References
1. Duffen A., Williams A. Should sevoflurane be used for maintenance of anesthesia in children. Br J Hosp Med (Lond) 2011;72(10):598. DOI: 10.12968/hmed.2011.72.10.598.
2. Castro R.H. Sevoflurane well-handled in children is excellent, but in the wrong hands can be life-threatening. J Invest Surg 2019 Jun 4:1-2. DOI: 10.1080/08941939.2019.1616860.
3. Mongodi S., Ottonello G., Viggiano R. et al. Ten-year experience with standardized nonoperating room anesthesia with Sevoflurane for MRI in children affected by neuropsychiatric disorders. BMC Anesthesiol 2019;19(1):235. DOI: 10.1186/s12871-019-0897-1.
4. Yamakage M., Hirata N., Saijo H. et al. Analysis of the composition of “original” and generic sevoflurane in routine use. Br J Anaesth 2007;99(6):819-23. DOI: 10.1093/bja/aem296.
5. Ai-Nasseri B. [Sevoflurane and propofol: original and generic (In French)]. Ann Fr Anesth Reanim 2008;27(1):120—2. DOI: 10.1016/j.annfar.2007.11.010.
6. Portella A.A., Laurence S.M., Rosa D.M. et al. A double-blind comparative study between Generic Sevoflurane and Sevorane. Rev Bras Anesthesiol 2012;60(5):466—74. DOI: 10.1016/S0034-7094(10)70058-1.
7. Yanli Y., Ozdemir M., Bakan N. et al. Comparison of two different forms of sevoflurane for anesthesia maintenance and recovery. Minerva Anestesiol 2017;83(3):274—81. DOI: 10.23736/S0375-9393.16.11406-3.
8. Denise A.O., Denise T.F., Carla H. et al. Minimum alveolar concentrations and hemodynamic effects of two different preparations of sevoflurane in pigs. Clinics (Sao Paulo) 2010;65(5):531—7. DOI: 10.1590/S1807-59322010000500011.
9. ASA Physical Status Classification System. Available at: https://www.asahq.org/standards-and-guidelines/asa-physical-status-classification-system.
10. Hurtwitz E.E., Simon M., Vinta S.R. et al. Adding examples to the ASA — Physical Status Classification improves correct assignment to patient. Anesthesiology 2017;126(4):614—22. DOI: 10.1097/ALN.0000000000001541.
11. Weibach C., Rahe-meyer N., Raymondos K. et al. Postoperative nausea and vomiting (PONV): usefulness of the Apfel-score for identification of high risk patients for PONV. Acta Anaesthesiol Belg 2006;57(4):361 —3.
12. Smith C.A., Ruth-Sahd L. Reducing the incidence of postoperative nausea and vomiting begins with risk screening: an evaluation of the evidence. J Perianesth Nurs 2016;31(2):158—71. DOI: 10.1016/j.jopan.2015.03.011.
13. Anesteziya v detskoi praktike. Pod red. V.V. Lazareva. M.: MEDpress-inform, 2016. C. 133—140. [Anesthesia in children's practice. Ed. by V.V. Lazarev. Moscow: MEDpress-inform, 2016. Pp. 133—140. (In Russ.)].
14. Denman W.T., Swanson E.L., Rosow D. et al. Pediatric evaluation of the bispectral index (BIS) monitor and correlation of BIS with end-tidal sevoflurane concentration in infants and children. Anesth Analg 2000;90(4):872—7. DOI: 10.1097/00000539-200004000-00018.
15. Bard J.W. The BIS monitor: a review and technology assessment. ANAA J 2001;69(6):477—83.
16. Toms A.S., Rai E. Operative fasting guidelines and postoperative feeding in paediatric anaesthesia-current concepts. Indian J Anaesth 2019;63(9):707—12. DOI: 10.4103/ija.IJA_484_19.
17. Eichhorn J.H., Cooper J.B., Cullen D.J. et al. Standards for patient monitoring during anesthesia at Harvard Medical School. JAMA 1986;256(8):1017—20.
18. Craft T.M., Upton P.M. Key questions in anaesthesia. 3rd edn. Oxford: BIOS Scientific, 2001. 140 p.
19. Miller anesthesia. Ed. by D.M. Ronald, H.C. Neal, I.E. Lars et al. Philadelphia: Elsevier, 2019. Vol. 1. Pp. 1330—1331.
20. Neotlozhnaya pomoshch' i intensivnaya terapiya v pediatrii. Pod. red. V.V. Lazareva. M.: MEDpress-inform, 2016. S. 68—74.
21. Holliday M.A., Segar W.E. The maintenance need for water in parenteral fluid therapy. Pediatrics 1957;19(5):823—32.
22. Tomal C.R., Silva A.G., Yamashita A.M. et al. Assessment of induction, recovery, agitation upon awakening, and consumption with the use of two brands of sevoflurane for ambulatory anesthesia. Rev Bras Anesthesiol 2012;62(2):54—172. DOI: 10.1016/S0034-7094(12)70115-0.
23. Li Y., Li Y.C., Zhang Y.N. et al. Degradation products of different water content sevoflurane in carbon dioxide absorbents by gas chromatography-mass spectrometry analysis. Chin Med J (Engl) 2011;124(7):1050—4.
24. Kharasch E.D., Subbarao G.N., Cromack K.R. et al. Sevoflurane formulation water content influences degradation by Lewis acids in vaporizers. Anesth Analg 2009;108(6):1796—802. DOI: 10.1213/ane.0b013e3181a3d72b.
25. Baker M.T. Sevoflurane: are there differences in products? Anesth Analg 2007;104(6):1447—51. DOI: 10.1213/01.ane.0000263031.96011.36.
26. Byon H.J., Choi B.M., Bang J.Y. et al. An open-label comparison of a new generic sevoflurane formulation with original sevoflurane in patients scheduled for elective surgery under general anesthesia. Clin Ther 2015;37(4):887—901. DOI: 10.1016/j.clinthera.2015.01.012.
