ABSTRACT
ABSTRACT INTRODUCTION: 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. OBJECTIVES: 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. METHOD: 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.
RESUMO INTRODUÇÃO: O veículo do propofol em soluções a 1 e 2% é a emulsão de óleo de soja a 10%, que pode provocar dor à injeção, instabilidade da solução e contaminação bacteriana. Formulações foram propostas com o objetivo de alterar o veículo e reduzir essas reações adversas. OBJETIVOS: Comparar a incidência de dor à injeção do propofol com a hipótese de redução associada à nanoemulsão e a ocorrência de efeitos adversos locais e sistêmicos com as duas formulações. MÉTODO: Após aprovação pelo Conselho de Ética em Pesquisa, foram incluídos neste estudo prospectivo pacientes submetidas a procedimentos cirúrgicos ginecológicos: grupos controle (n = 25) e nanoemulsão (n = 25). Foram monitorados frequência cardíaca, pressão arterial não invasiva e saturação periférica de oxigênio. Foram analisados dados demográficos e estado físico; tempo cirúrgico e volume total usado de propofol; efeitos adversos locais ou sistêmicos; alterações nas variáveis de monitoramento. Considerou-se significativo valor de p < 0,05. RESULTADOS: Não houve diferença entre os grupos em relação a: dados demográficos, tempos cirúrgicos, volume total usado de propofol, retirada do braço, presença de dor durante a injeção e variáveis de monitoramento. Verificou-se diferença estatística significativa na intensidade da dor no momento da indução da anestesia, com menor intensidade no grupo nanoemulsão. CONCLUSÕES: Ambas as formulações de propofol, lipídica e em nanoemulsão, elicitaram dor à injeção venosa, porém a solução de nanoemulsão promoveu dor em menor intensidade. O propofol lipídico e o propofol em nanoemulsão não apresentaram alterações hemodinâmicas e efeitos adversos de relevância clínica.
Subject(s)
Humans , Female , Adult , Pain/prevention & control , Polyethylene Glycols/pharmacology , Stearic Acids/pharmacology , Soybean Oil/pharmacology , Propofol/pharmacology , Lecithins/pharmacology , Anesthesia, General , Prospective Studies , Anesthetics, Intravenous/pharmacology , Emulsions , Injections, Intravenous/adverse effectsABSTRACT
INTRODUCTION: 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. OBJECTIVES: 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. METHOD: 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.