A double-blind comparative study between Generic Sevoflurane and Sevorane™.
OBJECTIVE
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.
Portella
Alfredo Augusto Vieira
AA
Anesthesiology Department of Hospital Universitário Pedro Ernesto, UERJ. aportella@openlink.com.br
Laurencel
Solange Maria
SM
Rosa
Deise Martins
DM
Rivera
Maria Isabel Moscote
MI
Quintero
Santiago Osorno
SO
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018685:Anesthetics, Inhalation; D004311:Double-Blind Method; D004339:Drug Compounding; D004349:Drug Packaging; D016568:Drugs, Generic; D005260:Female; D006801:Humans; D008297:Male; D008738:Methyl Ethers; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D000077149:Sevoflurane; D055815:Young Adult
D018685:Anesthetics, Inhalation; D016568:Drugs, Generic; D008738:Methyl Ethers; D000077149:Sevoflurane