Segurança e eficácia da administração alvo-controlada versus bolus intermitentes de propofol para sedação em colonoscopias: estudo randomizado controlado
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2021-09-28
Autores
Cuiabano, Igor Seror
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Universidade Estadual Paulista (Unesp)
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Justificativa e objetivos: A infusão alvo-controlada de propofol é bem estabelecida para a realização de anestesia geral, mas pode ser útil também em procedimentos diagnósticos e terapêuticos nos quais o controle adequado da sedação é importante tanto para a sua realização como para a segurança do paciente. O objetivo deste estudo foi comparar a administração alvo-controlada com a técnica de bolus intermitente para infusão de propofol durante a colonoscopia, quanto à segurança e eficácia. Métodos: Foi realizado estudo prospectivo, randomizado e controlado em 50 voluntários adultos ASA I-II, de ambos os sexos, com idade entre 18 e 65 anos, índice de massa corporal entre 19 e 30 kg.m-2, submetidos à colonoscopia em hospital terciário em Cuiabá-Mato Grosso, Brasil. Com monitorização padrão e oxigênio 2 L.min-1 via cateter nasal, todos os pacientes foram sedados com fentanil, 1 µg.kg-1 endovenoso, e alocados aleatoriamente em dois grupos iguais para receberem propofol em infusão alvo-controlada (Grupo infusão alvo-controlada, n = 25, alvo inicial de 2,0 µg.ml-1 e incrementos de 0,5 µg.ml-1 até a perda da consciência e durante o exame, de acordo com a necessidade) ou bolus intermitentes (Grupo bolus intermitentes, n = 25, indução com 1,0 mg.kg-1 e incrementos de 0,5 mg.kg-1 até a perda da consciência e durante o exame, de acordo com a necessidade). Os desfechos primários foram a necessidade e número de intervenções para permeabilizar as vias aéreas (segurança), por paciente, desencadeadas por SpO2 < 90%, e o número de ajustes de dose (eficácia) para controle do nível de sedação, por paciente. Os desfechos secundários foram a incidência de agitação por paciente, o consumo de propofol e o tempo para despertar. Resultados: Cinquenta pacientes completaram o estudo, com sua distribuição equitativa entre os grupos. Os valores [mediana (1o e 3o quartis)] para o número de intervenções nas vias aéreas e ajustes de doses, nos grupos infusão alvo-controlada e bolus intermitentes, foram, respectivamente 0 (0-0) versus 0 (0-0), p = 0,239, e 1 (0-1) versus 3 (1-4), p < 0,001. Os pacientes no grupo bolus intermitentes apresentaram maior número de agitação durante o exame, 1 (0-1) versus 2 (0-2), p < 0,001. Os valores para o tempo de despertar e de consumo de propofol (média ± desvio padrão) nos grupos infusão alvo-controlada e bolus intermitentes foram, respectivamente, 4,9 ± 1,4 versus 2,3 ± 1,6 minutos, p < 0,001, e 234 ± 46 µg.kg-1.min-1 versus 195 ± 44 µg.kg-1.min-1, p = 0,040. Conclusão: Para a realização de colonoscopias, a infusão alvo-controlada de propofol é igualmente segura à sua administração por bolus intermitentes, mas reduz a incidência de agitação e a necessidade de ajustes de dose. No entanto, com os bolus intermitentes o consumo de propofol é menor e o tempo de despertar é mais rápido.
Background and Objective: Target-controlled infusion is well established for accurate drug delivery during anesthesia, and it could also be useful in diagnostic procedures, in which the control of the level of sedation is important for performing the procedure and for patient safety. The aim of this study was to compare the target-controlled infusion with the intermittent bolus technique for propofol infusion during colonoscopy, regarding safety and efficacy. Methods: We conducted a prospective single-blinded randomized controlled trial in 50 adults ASA I-II, both sexes, aged 20 to 65 years, body mass index between 19 to 30 kg.m-2, undergoing colonoscopy at a tertiary hospital in Brazil. With continuous standard monitoring and 2 L.min-1 oxygen supply via a nasal catheter, all patients received intravenous fentanyl, 1 μg.kg-1, and were randomly allocated in two groups to be sedated with propofol by target-controlled infusion (Target-controlled infusion group, n = 25, effect target = 2 μg.ml-1 plus 0.5 μg.ml-1 towards unconsciousness and during the exam, according to the need, meaning agitation or reaction to the procedure) or intermittent bolus (Intermittent bolus control group, n = 25, 1 mg.kg-1 plus 0.5 mg.kg-1 towards unconsciousness and during the exam, according to the need). The primary outcome was the need of airway maneuvers (safety), evaluated as the number of jaw-thrust and facemask ventilation interventions triggered by SpO2 < 90%, per patients, and the number of interventions to control the level of sedation (efficacy), defined as number of dose adjustments, per patients (target correction or additional bolus of propofol). Secondary outcomes include incidence of agitation, propofol consumption and time to wake-up. Results: Fifty patients completed the study, with equal distribution per patients per group. The values [median (1st and 3rd quartiles)] for the number of airway maneuvers and the number of interventions to control the level of sedation, in groups target-controlled infusion and intermittent bolus were, respectively, 0 (0-0) versus 0 (0-0), p = 0.239, and 1 (0-1) versus 3 (1-4), p < 0.001. Patients in intermittent bolus presented a higher number of agitations during the exam, 1 (0-1) versus 2 (0-2), p < 0.001. The values for wake-up time and propofol consumption (mean ± standard deviation) in groups target-controlled infusion and intermittent bolus were, respectively, 4.9 ± 1.4 versus 2.3 ± 1.6 minutes, p < 0.001, and 234 ± 46 µg.kg-1.min-1 versus 195 ± 44 µg.kg-1.min-1, p = 0.040. Conclusion: For colonoscopies, target-controlled infusion is equally safe as intermittent bolus infusion of propofol for sedation but reduces the incidence of agitation and the need for dose adjustments. Nevertheless, intermittent bolus reduces propofol consumption and wake-up time.
Background and Objective: Target-controlled infusion is well established for accurate drug delivery during anesthesia, and it could also be useful in diagnostic procedures, in which the control of the level of sedation is important for performing the procedure and for patient safety. The aim of this study was to compare the target-controlled infusion with the intermittent bolus technique for propofol infusion during colonoscopy, regarding safety and efficacy. Methods: We conducted a prospective single-blinded randomized controlled trial in 50 adults ASA I-II, both sexes, aged 20 to 65 years, body mass index between 19 to 30 kg.m-2, undergoing colonoscopy at a tertiary hospital in Brazil. With continuous standard monitoring and 2 L.min-1 oxygen supply via a nasal catheter, all patients received intravenous fentanyl, 1 μg.kg-1, and were randomly allocated in two groups to be sedated with propofol by target-controlled infusion (Target-controlled infusion group, n = 25, effect target = 2 μg.ml-1 plus 0.5 μg.ml-1 towards unconsciousness and during the exam, according to the need, meaning agitation or reaction to the procedure) or intermittent bolus (Intermittent bolus control group, n = 25, 1 mg.kg-1 plus 0.5 mg.kg-1 towards unconsciousness and during the exam, according to the need). The primary outcome was the need of airway maneuvers (safety), evaluated as the number of jaw-thrust and facemask ventilation interventions triggered by SpO2 < 90%, per patients, and the number of interventions to control the level of sedation (efficacy), defined as number of dose adjustments, per patients (target correction or additional bolus of propofol). Secondary outcomes include incidence of agitation, propofol consumption and time to wake-up. Results: Fifty patients completed the study, with equal distribution per patients per group. The values [median (1st and 3rd quartiles)] for the number of airway maneuvers and the number of interventions to control the level of sedation, in groups target-controlled infusion and intermittent bolus were, respectively, 0 (0-0) versus 0 (0-0), p = 0.239, and 1 (0-1) versus 3 (1-4), p < 0.001. Patients in intermittent bolus presented a higher number of agitations during the exam, 1 (0-1) versus 2 (0-2), p < 0.001. The values for wake-up time and propofol consumption (mean ± standard deviation) in groups target-controlled infusion and intermittent bolus were, respectively, 4.9 ± 1.4 versus 2.3 ± 1.6 minutes, p < 0.001, and 234 ± 46 µg.kg-1.min-1 versus 195 ± 44 µg.kg-1.min-1, p = 0.040. Conclusion: For colonoscopies, target-controlled infusion is equally safe as intermittent bolus infusion of propofol for sedation but reduces the incidence of agitation and the need for dose adjustments. Nevertheless, intermittent bolus reduces propofol consumption and wake-up time.
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Propofol, Colonoscopia, Propofol, Colonoscopy, Sedação profunda, Deep sedation