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
Abstract
Background: This 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
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
References
1. Westenskow DR. Closed-loop control of blood pressure, ventilation, and anesthesia delivery. Int J Clin Monit Comput. 1987;4:69−74.
2. Schwilden H, Stoeckel H, Schuttler J. Closed-loop feedback control of propofol anaesthesia by quantitative EEG analysis in humans. Br J Anaesth. 1989;62:290−6.
3. Kenny GN, Mantzaridis H. Closed-loop control of propofol anaesthesia. Br J Anaesth. 1999;83:223−8.
4. Dussaussoy C, Peres M, Jaoul V, et al. Automated titration of propofol and remifentanil decreases the anesthesiologist’s workload during vascular or thoracic surgery: a randomized prospective study. J Clin Monit Comput. 2014;28:35−40.
5. Puri GD, Kumar B, Aveek J. Closed-loop anaesthesia delivery system (CLADS) using bispectral index: a performance assessment study. Anaesth Intensive Care. 2007;35:357−62.
6. Liu N, Chazot T, Trillat B, et al. Feasibility of closed-loop titration of propofol guided by the Bispectral Index for general anaesthesia induction: a prospective randomized study. Eur J Anaesthesiol. 2006;23:465−9.
7. Puri GD, Mathew PJ, Biswas I, et al. A Multicenter Evaluation of a closed-loop anesthesia delivery system: a randomized controlled trial. Anesth Analg. 2016;122:106−14.
8. Liu N, Chazot T, Genty A, et al. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006;104:686−95.
9. Agarwal J, Puri GD, Mathew PJ. Comparison of closed loop vs. manual administration of propofol using the Bispectral index in cardiac surgery. Acta Anaesthesiol Scand. 2009;53:390−7.
10. Liu N, Chazot T, Hamada S, et al. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011;112:546−57.
11. Bibian S, Dumont GA, Black I. Closed-loop target-controlled infusion systems: stability and performance aspects. Mil Med. 2015;180(3 Suppl):96−103.
12. Liu Y, Li M, Yang D, et al. Closed-loop control better than openloop control of profofol TCI guided by BIS: a randomized, controlled, multicenter clinical trial to evaluate the CONCERT-CL closed-loop system. PLoS One. 2015;10:e0123862.
13. Biswas I, Mathew PJ, Singh RS, Puri GD. Evaluation of closedloop anesthesia delivery for propofol anesthesia in pediatric cardiac surgery. Paediatr Anaesth. 2013;23:1145−52.
14. Orliaguet GA, Benabbes Lambert F, Chazot T, Glasman P, Fischler M, Liu N. Feasibility of closed-loop titration of propofol and remifentanil guided by the bispectral monitor in pediatric and adolescent patients: a prospective randomized study. Anesthesiology. 2015;122(4):759−67.
15. Marsh B, White M, Morton N, Kenny GN. Pharmacokinetic model driven infusion of propofol in children. Br J Anaesth. 1991;67:41 −8.
16. Liu N, Chazot T, Trillat B, et al. Closed-loop control of consciousness during lung transplantation: an observational study. J Cardiothorac Vasc Anesth. 2008;22:611−5.
17. Varvel JR, Donoho DL, Shafer SL. Measuring the predictive performance of computer-controlled infusion pumps. J Pharmacokinet Biopharm. 1992;20:63−94.
18. West N, Dumont GA, van Heusden K, et al. Robust closed-loop control of induction and maintenance of propofol anesthesia in children. Paediatr Anaesth. 2013;23:712−9.
19. Liu N, Pruszkowski O, Leroy JE, et al. Automatic administration of propofol and remifentanil guided by the bispectral index during rigid bronchoscopic procedures: a randomized trial. Can J Anaesth. 2013;60:881−7.
20. Wang D, Song Z, Zhang C, Chen P. Bispectral index monitoring of the clinical effects of propofol closed-loop target-controlled infusion: Systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2021;100:e23930.
21. Mahr N, Bouhake Y, Chopard G, et al. Postoperative Neurocognitive disorders after closed-loop versus manual target controlled-infusion of propofol and remifentanil in patients undergoing elective major noncardiac surgery: The Randomized Controlled Postoperative Cognitive Dysfunction-Electroencephalographic-Guided Anesthetic Administration Trial. Anesth Analg. 2021;133:837−47.
22. Sethi N, Dutta A, Puri GD, et al. Evaluation of automated delivery of propofol using a closed-loop anesthesia delivery system in patients undergoing thoracic surgery: a randomized controlled study. J Cardiothorac Vasc Anesth. 2021;35:1089−95.
23. Cotoia A, Mirabella L, Beck R, et al. Effects of closed-loop intravenous anesthesia guided by Bispectral Index in adult patients on emergence delirium: a randomized controlled study. Minerva Anestesiol. 2018;84:437−46.
24. Lennertz R, Pryor KO, Raz A, et al. Connected consciousness after tracheal intubation in young adults: an international multicentre cohort study. Br J Anaesth. 2023;130:e217−24.
Submitted date:
11/15/2022
Accepted date:
05/18/2023
Facebook
Google+
Twitter
LinkedIn
Mendeley
StumbleUpon
CiteULike
Reddit
Email