A Double-Blind Comparative Study between Generic Sevoflurane and Sevorane (TM)

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

来源：Revista Brasileira de Anestesiologia, 2010, 60(5): 466-474.

DOI：10.1590/S0034-70942010000500003

• ANESTHESICS, Volatile: sevoflurane.

Portella AAV, Laurencel SM, Rosa DM, Rivera MIM, Quintero SO A Double-Blind Comparative Study between Generic Sevoflurane and Sevorane (TM).
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 Sevorane (TM), 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, SpO(2), PETCO2, 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 l). 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.

• 出版日期2010-10