Comparative evaluation of propofol in nanoemulsion with solutol and soy lecithin for general anesthesia.
BACKGROUND
The vehicle for propofol in 1 and 2% solutions is soybean oil emulsion 10%, which may cause pain on injection, instability of the solution and bacterial contamination. Formulations have been proposed aiming to change the vehicle and reduce these adverse reactions.


OBJECTIVE
To compare the incidence of pain caused by the injection of propofol, with a hypothesis of reduction associated with nanoemulsion and the occurrence of local and systemic adverse effects with both formulations.


METHODS
After approval by the CEP, patients undergoing gynecological procedures were included in this prospective study: control (n=25) and nanoemulsion (n=25) groups. Heart rate, noninvasive blood pressure and peripheral oxygen saturation were monitored. Demographics and physical condition were analyzed; surgical time and total volume used of propofol; local or systemic adverse effects; changes in variables monitored. A value of p<0.05 was considered significant.


RESULTS
There was no difference between groups regarding demographic data, surgical times, total volume of propofol used, arm withdrawal, pain during injection and variables monitored. There was a statistically significant difference in pain intensity at the time of induction of anesthesia, with less pain intensity in the nanoemulsion group.


CONCLUSIONS
Both lipid and nanoemulsion formulations of propofol elicited pain on intravenous injection; however, the nanoemulsion solution elicited a less intense pain. Lipid and nanoemulsion propofol formulations showed neither hemodynamic changes nor adverse effects of clinical relevance.
Irmandade da Santa Casa de Misericórdia de São Paulo, São Paulo, SP, Brazil.
José Carlos
JC
Rittes
Irmandade da Santa Casa de Misericórdia de São Paulo, São Paulo, SP, Brazil.
Guilherme
G
Cagno
Irmandade da Santa Casa de Misericórdia de São Paulo, São Paulo, SP, Brazil; Faculdade de Ciências Médicas, Santa Casa de Misericórdia de São Paulo, São Paulo, SP, Brazil.
Marcelo Vaz
MV
Perez
Irmandade da Santa Casa de Misericórdia de São Paulo, São Paulo, SP, Brazil; Faculdade de Ciências Médicas, Santa Casa de Misericórdia de São Paulo, São Paulo, SP, Brazil. Electronic address: rtimao@uol.com.br.
Ligia Andrade da Silva Telles
LA
Mathias
D000328:Adult; D000768:Anesthesia, General; D018686:Anesthetics, Intravenous / Q000494:pharmacology; D004655:Emulsions; D005260:Female; D006801:Humans; D007275:Injections, Intravenous / Q000009:adverse effects; D054709:Lecithins / Q000494:pharmacology*; D010146:Pain / Q000517:prevention & control*; D011092:Polyethylene Glycols / Q000494:pharmacology*; D015742:Propofol / Q000494:pharmacology*; D011446:Prospective Studies; D013024:Soybean Oil / Q000494:pharmacology*; D013229:Stearic Acids / Q000494:pharmacology*
D018686:Anesthetics, Intravenous; D004655:Emulsions; D054709:Lecithins; D013229:Stearic Acids; D011092:Polyethylene Glycols; C067028:Solutol HS 15; D013024:Soybean Oil; D015742:Propofol
Anestesia geral; Emulsions; Emulsões; General anesthesia; Nanoestruturas; Nanostructures; Propofol/farmacocinética; Propofol/farmacologia; Propofol/pharmacokinetics; Propofol/pharmacology