Brazilian Journal of Anesthesiology
https://bjan-sba.org/article/doi/10.1016/j.bjane.2023.05.003
Brazilian Journal of Anesthesiology
Original Investigation

Accuracy of closed-loop and open-loop propofol delivery systems by bispectral index monitoring in breast surgery patients: a prospective randomized trial

Precisão dos sistemas de administração de propofol em circuito fechado e circuito aberto por meio do monitoramento do índice bispectral em pacientes de cirurgia de mama: um estudo prospectivo randomizado

Tian Xie, Yong Wang, Yuhua Liu, Junjie Li, Weijing Li, Hongmeng Xu

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Abstract

BackgroundThis randomized and controlled prospective study tested the hypothesis that closed-loop Target-Controlled Infusion (TCI) of propofol would be associated with better system performance when compared with open-loop controlled delivery of propofol.

Methods: Patients scheduled for elective breast surgery were randomly assigned to two groups: a closed-loop group, in which propofol infusion was performed by a closed-loop TCI system that used the Bispectral Index (BIS) as a feedback parameter to titrate the rate of propofol infusion, and an open-loop group, in which propofol infusion was performed manually and guided by the bispectral index.

Results: A total of 156 patients were recruited for this study (closed-loop group n = 79; open-loop group n = 77). The Global Score (GS) of the closed-loop group was lower than that of the open-loop group (34.3 and 42.2) (p = 0.044). The proportions of time with a BIS value between 40 and 60 were almost identical in the closed-loop group and the open-loop group (68.7 ± 10.6% and 66.7 ± 13.3%) (p = 0.318). The individuals in the closed-loop group consumed more propofol compared with those in the open-loop group (7.20 ± 1.65 mg.kg−1.h−1 vs. 6.03 ± 1.31 mg.kg−1.h−1, p < 0.001). No intraoperative recall, somatic events or adverse events occurred. No significant difference in heart rate was observed between the two groups (p = 0.169).

Conclusion: The closed-loop protocol was associated with lower BIS variability and lower out-of-range BIS values, at the cost of a greater consumption of propofol when compared to the open loop group.

Register number: ChiCTR-INR-17010399.

Keywords

Anesthesia; Closed-loop; Drug delivery system; Infusion pump; Intravenous; Propofol

Resumo

Introdução

Este estudo prospectivo randomizado e controlado testou a hipótese de que a infusão alvo-controlada (TCI) de propofol em circuito fechado estaria associada a um melhor desempenho do sistema quando comparada com a administração controlada de propofol em circuito aberto.

Métodos

As pacientes agendadas para cirurgia eletiva de mama foram distribuídas aleatoriamente em dois grupos: um grupo de circuito fechado, no qual a infusão de propofol foi realizada por um sistema TCI de circuito fechado que utilizou o Índice Bispectral (BIS) como parâmetro de feedback para titular a taxa de propofol. e um grupo em circuito aberto, no qual a infusão de propofol foi realizada manualmente e guiada pelo índice bispectral.

Resultados

Um total de 156 pacientes foram recrutados para este estudo (grupo de circuito fechado n = 79; grupo de circuito aberto n = 77). O Escore Global (ES) do grupo de circuito fechado foi inferior ao do grupo de circuito aberto (34,3 e 42,2) (p = 0,044). As proporções de tempo com valor do BIS entre 40 e 60 foram quase idênticas no grupo de circuito fechado e no grupo de circuito aberto (68,7 ± 10,6% e 66,7 ± 13,3%) (p = 0,318). Os indivíduos do grupo de circuito fechado consumiram mais propofol em comparação com aqueles do grupo de circuito aberto (7,20 ± 1,65 mg.kg–1.h–1 vs. 6,03 ± 1,31 mg.kg–1.h–1, p < 0,001). Não houve recordação intraoperatória, eventos somáticos ou eventos adversos. Não foi observada diferença significativa na frequência cardíaca entre os dois grupos (p = 0,169).

Conclusão

O protocolo de circuito fechado foi associado a menor variabilidade do BIS e menores valores fora da faixa do BIS, ao custo de um maior consumo de propofol quando comparado ao grupo de circuito aberto.

Palavras-chave

Anestesia; Circuito fechado; Sistema de administração de medicamentos; Bomba de infusão; Intravenosa; Propofol

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Submitted date:
11/15/2022

Accepted date:
05/18/2023

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