Brazilian Journal of Anesthesiology
https://bjan-sba.org/journal/rba/article/doi/10.1590/S0034-70942010000500003
Brazilian Journal of Anesthesiology
Scientific Article

Estudo comparativo duplamente encoberto entre Sevoflurano Genérico e Sevorane®

A double-blind comparative study between generic Sevoflurane and SevoraneTM

Alfredo Augusto Vieira Portella; Solange Maria Laurencel; Deise Martins Rosa; Maria Isabel Moscote Rivera; Santiago Osorno Quintero

http://dx.doi.org/10.1590/S0034-70942010000500003 Braz J Anesthesiol, vol.60, n5, p.466-474, 2010
PDF Português
PDF English
Downloads: 0
Views: 764

Resumo

JUSTIFICATIVA E OBJETIVOS: O sevoflurano é acondicionado em três tipos de recipientes. As diferenças de propriedades físico-químicas desses produtos se devem aos diversos processos de fabricação, embora sejam essencialmente idênticos quanto às provas de comparação química. Existe a hipótese de que a molécula do sevoflurano possa apresentar instabilidade química devido à formação de ácidos de Lewis em conse quência do material utilizado para a fabricação dos frascos e do teor de água. O objetivo deste trabalho foi analisar a eficácia clínica do sevoflurano quando acondicionado em frascos diferentes. MÉTODO: Foram estudados 64 pacientes adultos distribuídos aleatoriamente em dois grupos. Foram utilizados dois vaporizadores Datex-Ohmeda, sendo um abastecido apenas com Sevoflurano Genérico e o outro com Sevorane®. O coordenador do estudo foi o responsável pelo abastecimento dos vaporizadores e não realizou nenhuma anestesia. Em ambos os grupos, utilizou-se a mesma técnica anestésica e a mesma monitoração (ECG, FC, SpO2, P ET CO2, BIS, SEF, TOF, % INSP, % EXP, PAS, PAD). RESULTADOS: Durante a anestesia não houve diferença entre os grupos. Houve diferença estatística entre a interrupção do sevoflurano e a abertura espontânea dos olhos (13,91 ± 6,39 min Grupo II, e 10,34 ± 6,05 min Grupo I) e a interrupção do sevoflurano e o aperto de mão ao comando verbal (15,38 ± 6,47 min Grupo II, e 11,88 ± 6,60 min Grupo I). Não houve diferença estatística entre a interrupção do sevoflurano e o momento em que os pacientes atingiram Índice de Aldrete-Kroulik igual ou superior a 8. CONCLUSÕES: Durante a anestesia, não houve diferença entre os grupos. Embora o despertar tenha sido 3,5 minutos mais rápido no Grupo I (Sevoflurano Genérico), os anestesiologistas não observaram qualquer diferença no comportamento clínico dos pacientes quanto a esse aspecto

Palavras-chave

ANESTÉSICOS, Volátil

Abstract

BACKGROUND AND OBJECTIVES: Sevoflurane is presented in three types of vials. The differences in physical-chemical properties of those products are due to different manufacturing processes, although they are essentially identical regarding chemical comparison tests. It has been hypothesized that the Sevoflurane molecule could present chemical instability due to the formation of Lewis acids as a consequence of the materials used in the fabrication of the vials and the water content. The objective of this study was to analyze the clinical efficacy of Sevoflurane conditioned in different vials. METHODS: Sixty-four adult patients were randomly divided into two groups. Two Datex-Ohmeda vaporizers, one with only Generic Sevoflurane and the other with SevoraneTM, were used. The study coordinator was responsible for supplying the vaporizers and he did not participated in none anesthetic procedures. The same anesthetic technique and monitoring (ECG, HR, SpO2, P ET CO2, BIS, SEF, TOF, % INSP, % EXP, SBP, and DBP) were used in both groups. RESULTS: During anesthesia, differences were not observed between both groups. A statistically significant difference was observed in the time between the interruption of Sevoflurane and spontaneous eye opening (13,91 ± 6.39 min in Group II, and 10.34 ± 6.05 min in Group I) and the interruption of Sevoflurane and handgrip on verbal command (15.38 ± 6.47 min in Group II, and 11.88 ± 6.60 in Group I). A statistically significance difference was not observed between the interruption of Sevoflurane and the moment that patients achieved an Aldrete- Kroulik index equal or above 8. CONCLUSIONS: during anesthesia a significant difference between both groups was not observed. Although awakening was 3,5 minutes faster in Group I (Generic Sevoflurane), anesthesiologists did not observe any difference in the clinical behavior of patients

Keywords

ANESTHESICS, Volatile

References

Baker MT. Sevoflurane: are there differences in products?. Anesth Analg. 2007;104:1447-1451.

Kharasch ED. Sevoflurane: the challenges of safe formulation. APSF Newsletter. 2007;48.

O'Neill B, Hafiz MA, DeBeer DAH. Corrosion of Penlon sevoflurane vaporisers. Anaesthesia. 2007;62.

Kharasch ED, Subbarao GN, Stephens DA. Influence of sevoflurane formulation water conten on degradation to hydrogen fluoride in vaporizers. Anesthesiology. 2007;107.

Stephens DA, Kharasch ED, Cromack KR. Sevoflurane vaporizers contain Lewis acid metal oxides that can potentially degrade sevoflurane. Anesthesiology. 2007;107.

Cromack KR, Kharasch ED, Stephens DA. Influence of formulation water content on sevoflurane degradation in vitro by Lewis acids. Anesthesiology. 2007;107.

Grupa A, Ely J. Faulty sevoflurane vaporizer. Anesthesia. 2007;62.

Rosner B. Fundamentals of Biostatistics. 1986.

Timm NH. Multivariate Analysis with Applications in Educations and Psychology. 1975.

Malviya S, Lerman J. The blood/gas solubilities of sevoflurane, isoflurane, halothane and serum constituent concentrations in neonates and adults. Anesthesiology. 1990;72:793-796.

Yasuda N, Targ AG, Eger EI. II - Solubility of I-653, sevoflurane, isoflurane and halothane in human tissues. Anesth Analg. 1989;69:370-373.

Katoh T, Suguro Y, Nakajima R. Blood concentrations of sevoflurane and isoflurane on recovery from anesthesia. Br J Anaesth. 1992;69:259-262.

5dcea8b60e8825e15abf58f1 rba Articles
Links & Downloads
2352-2291 (Electronic) 0104-0014 (Printed)
Braz J Anesthesiol ©2024 All rights reserved.

Braz J Anesthesiol

Share this page
Page Sections