Brazilian Journal of Anesthesiology
https://bjan-sba.org/article/doi/10.1590/S0034-70942012000300005
Brazilian Journal of Anesthesiology
Scientific Article

Estudo comparativo entre propofol em nanoemulsão não lipídica com solutol e em emulsão com lecitina

A comparative study of non-lipid nanoemulsion of propofol with solutol and propofol emulsion with lecithin

Thiago Alves Rodrigues; Ricardo Andrade Alexandrino; Marcelo Epstein Kanczuk; Judymara Lauzi Gozzani; Ligia Andrade da Silva Telles Mathias

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Resumo

JUSTIFICATIVA E OBJETIVOS: Formulações têm sido propostas com o objetivo de reduzir as reações adversas decorrentes da emulsão lipídica de óleo de soja utilizada como veículo do propofol. O objetivo deste estudo foi avaliar comparativamente, em sedação para endoscopia, a segurança, eficácia e efeitos adversos do uso do propofol em nanoemulsão em relação ao propofol comercializado atualmente. MÉTODO: Foram incluídos neste estudo prospectivo 150 pacientes submetidos a procedimentos endoscópicos digestivos altos, divididos em grupo-controle (Grupo CONT; n = 75) e grupo nanoemulsão (Grupo NE; n = 75). Foram monitorados FC, PAS, PAD, SpO2 e BIS (considerado apropriado entre 65 e 75, durante o procedimento). Foram analisados: gênero, idade, peso, altura, IMC, estado físico ASA; tempos e doses utilizadas; efeitos adversos (sinais flogísticos e dor à injeção, apneia, náuseas/vômitos) e alterações nas variáveis de monitoramento. Considerou-se significativo p < 0,05. RESULTADOS: Os grupos foram homogêneos quanto aos dados antropométricos e estado físico. Nenhum paciente apresentou apneia nem sinais flogísticos no local da injeção. A incidência de dor à injeção no grupo CONT foi 82,7% e 53,3% no grupo NE (p < 0,001) e de náuseas e vômitos foi 10,7% no grupo CONT e 2,7% no grupo NE (p > 0,05). Os tempos, as doses de indução e os valores das PAS e PAD ao final do exame e no momento da alta da SRPA foram menores no grupo NE (p < 0,05). CONCLUSÕES: O propofol lipídico e o propofol em nanoemulsão, nas doses utilizadas, foram equivalentes em relação a eficácia, segurança e efeitos adversos, ressaltando-se a menor incidência de dor à injeção da formulação em nanoemulsão.

Palavras-chave

anestésicos, venoso, propofol, cirurgia, endoscopia, sedação, consciente

Abstract

BACKGROUND AND OBJECTIVES: Some formulations have been proposed to reduce the adverse reactions due to the lipid emulsion containing soybean oil used as propofol carrier. This study for endoscopy sedation was aimed at evaluating and comparing the safety, effectiveness and adverse effects of the use of propofol nanoemulsion compared to propofol currently commercialized. METHOD: In this prospective study, 150 patients were submitted to upper digestive endoscopy. These patients were allocated into two groups: the control group (CONT Group; n = 75) and the nanoemulsion group (NE Group; n = 75). HR, SBP, DBP, SpO2 and BIS (which is considered to be appropriate between 65 and 75 during procedure) were monitored. Gender, age, weight, height, BMI, ASA physical status, times and doses were analyzed, as well as adverse effects (phlogistic signs and pain on injection, apnea, nausea/vomiting) and alterations in monitoring variables. A p-value < 0.05 was considered significant. RESULTS: The groups had similar results concerning anthropometric data and physical status. None of the patients developed apnea or presented phlogistic signs in the injection site. The incidence of pain on injection in the CONT Group was 82.7% and 53.3% in the NE Group (p < 0.001), and the incidence of nausea and vomiting was 10.7% in the CONT Group and 2.7% in the NE Group (p > 0.05). The times, induction doses and the SBP and DBP values at the end of examination and at the moment of discharge from the PACU were lower in the NE Group (p < 0.05). CONCLUSIONS: Lipid propofol and propofol nanoemulsion were equivalent concerning effectiveness, safety and adverse effects in the doses used. There was a lower incidence of pain on injection in the nanoemulsion formulation.

Keywords

conscious sedation, endoscopy, propofol

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