Safety and efficacy of target-controlled infusion versus intermittent bolus administration of propofol for sedation in colonoscopy: a randomized controlled trial
Segurança e eficácia da infusão alvo-controlada versus administração intermitente em bolus de propofol para sedação em colonoscopia: um ensaio clínico randomizado
Igor Seror Cuiabano, Priscila de Miranda Garbin, Norma Sueli Pinheiro Módolo, Paulo do Nascimento Junior
Abstract
Background
Our objective was to compare the safety and efficacy of Target-Controlled Infusion (TCI) versus intermittent bolus of propofol for colonoscopy sedation.
Methods
We conducted a randomized (1:1), single-blind, parallel-group superiority trial with fifty ASA I or II patients, both sexes, aged 18 to 65 years, Body Mass Index ≤ 30 kg.m−2, undergoing colonoscopy, allocated to receive propofol by TCI (effect-site, 2 μg.mL−1 plus 0.5 μg.mL−1 until unconsciousness and as necessary for agitation) or intermittent bolus (1 mg.kg−1 plus 0.5 mg.kg−1 every 5 minutes or as above). The primary safety outcome was the need for airway maneuvers and the primary efficacy outcome was the need for interventions to adjust the level of sedation. Secondary outcomes included incidence of agitation, propofol dose, and time to recovery.
Results
The median (IQR) number of airway maneuvers and interventions needed to adjust sedation was 0 (0‒0) vs. 0 (0‒0) (p = 0.239) and 1 (0‒1) vs. 3 (1‒4) (p < 0.001) in the TCI and control groups, respectively. Agitation was more common in the intermittent bolus group ‒ 2 (0‒2) vs. 1 (0‒1), p < 0.001. The mean ± SD time to recovery was 4.9 ± 1.4 minutes in the TCI group vs. 2.3 ± 1.6 minutes in the control group (p < 0.001). The total propofol dose was higher in the TCI group (234 ± 46 µg.kg−1.min−1 vs. 195 ± 44 µg.kg−1.min−1 (p = 0.040)).
Conclusions
During colonoscopy, TCI is as safe as intermittent bolus of propofol while reducing the incidence of agitation and the need for dose adjustments. However, intermittent bolus administration was associated with lower total propofol dose and earlier recovery.
Keywords
Resumo
Introdução
Nosso objetivo foi comparar a segurança e eficácia da infusão alvo-controlada (IAC) versus bolus intermitente de propofol para sedação colonoscópica.
Métodos
Realizamos um estudo de superioridade randomizado (1:1), simples-cego, de grupos paralelos, com cinquenta pacientes ASA I ou II, ambos os sexos, com idade entre 18 e 65 anos, Índice de Massa Corporal ≤ 30 kg.m−2, submetidos à colonoscopia, alocado para receber propofol por TCI (local de efeito, 2 μg.mL−1 mais 0,5 μg.mL−1 até a inconsciência e conforme necessário para agitação) ou bolus intermitente (1 mg.kg−1 mais 0,5 mg.kg−1 a cada 5 minutos ou como acima). O desfecho primário de segurança foi a necessidade de manobras nas vias aéreas e o desfecho primário de eficácia foi a necessidade de intervenções para ajustar o nível de sedação. Os desfechos secundários incluíram incidência de agitação, dose de propofol e tempo de recuperação.
Resultados
A mediana (IQR) do número de manobras e intervenções nas vias aéreas necessárias para ajustar a sedação foi 0 (0‒0) vs. 0 (0‒0) (p = 0,239) e 1 (0‒1) vs. (p < 0,001) nos grupos IAC e controle, respectivamente. A agitação foi mais comum no grupo de bolus intermitente ‒ 2 (0‒2) vs. 1 (0‒1), p < 0,001. O tempo médio ± DP para recuperação foi de 4,9 ± 1,4 minutos no grupo IAC versus 2,3 ± 1,6 minutos no grupo controle (p < 0,001). A dose total de propofol foi maior no grupo IAC (234 ± 46 µg.kg−1.min−1 vs. 195 ± 44 µg.kg−1.min−1 (p = 0,040)).
Conclusão
Durante a colonoscopia, a AIC é tão segura quanto o bolus intermitente de propofol, ao mesmo tempo que reduz a incidência de agitação e a necessidade de ajustes de dose. No entanto, a administração intermitente em bolus foi associada a menor dose total de propofol e recuperação mais precoce.
Palavras-chave
References
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Submitted date:
06/28/2021
Accepted date:
06/15/2022
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