Document Detail

A double-blind comparative study between Generic Sevoflurane and Sevorane™.
MedLine Citation:
PMID:  20863927     Owner:  NLM     Status:  MEDLINE    
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™, 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.
Alfredo Augusto Vieira Portella; Solange Maria Laurencel; Deise Martins Rosa; Maria Isabel Moscote Rivera; Santiago Osorno Quintero
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Revista brasileira de anestesiologia     Volume:  60     ISSN:  1806-907X     ISO Abbreviation:  Rev Bras Anestesiol     Publication Date:    2010 Sep-Oct
Date Detail:
Created Date:  2010-09-24     Completed Date:  2011-03-03     Revised Date:  2014-02-05    
Medline Journal Info:
Nlm Unique ID:  0401316     Medline TA:  Rev Bras Anestesiol     Country:  Brazil    
Other Details:
Languages:  eng; por     Pagination:  466-74     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 Elsevier Editora Ltda. All rights reserved.
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MeSH Terms
Aged, 80 and over
Anesthetics, Inhalation*
Double-Blind Method
Drug Compounding
Drug Packaging
Drugs, Generic*
Methyl Ethers*
Middle Aged
Nebulizers and Vaporizers
Young Adult
Reg. No./Substance:
0/Anesthetics, Inhalation; 0/Drugs, Generic; 0/Methyl Ethers; 28523-86-6/sevoflurane

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