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Closed-loop control better than open-loop control of profofol TCI guided by BIS: a randomized, controlled, multicenter clinical trial to evaluate the CONCERT-CL closed-loop system.

PloS one (2015-04-18)
Yu Liu, Min Li, Dong Yang, Xuena Zhang, Anshi Wu, Shanglong Yao, Zhanggang Xue, Yun Yue
ABSTRACT

The CONCERT-CL closed-loop infusion system designed by VERYARK Technology Co., Ltd. (Guangxi, China) is an innovation using TCI combined with closed-loop controlled intravenous anesthesia under the guide of BIS. In this study we performed a randomized, controlled, multicenter study to compare closed-loop control and open-loop control of propofol by using the CONCERT-CL closed-loop infusion system. 180 surgical patients from three medical centers undergone TCI intravenous anesthesia with propofol and remifentanil were randomly assigned to propofol closed-loop group and propofol opened-loop groups. Primary outcome was global score (GS, GS = (MDAPE+Wobble)/% of time of bispectral index (BIS) 40-60). Secondary outcomes were doses of the anesthetics and emergence time from anesthesia, such as, time to tracheal extubation. There were 89 and 86 patients in the closed-loop and opened-loop groups, respectively. GS in the closed-loop groups (22.21±8.50) were lower than that in the opened-loop group (27.19±15.26) (p=0.009). The higher proportion of time of BIS between 40 and 60 was also observed in the closed-loop group (84.11±9.50%), while that was 79.92±13.17% in the opened-loop group, (p=0.016). No significant differences in propofol dose and time of tracheal extubation were observed. The frequency of propofol regulation in the closed-loop group (31.55±9.46 times/hr) was obverse higher than that in the opened-loop group (6.84±6.21 times/hr) (p=0.000). The CONCERT-CL closed-loop infusion system can automatically regulate the TCI of propofol, maintain the BIS value in an adequate range and reduce the workload of anesthesiologists better than open-loop system. ChiCTR ChiCTR-OOR-14005551.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
N,N′-Methylenebis(acrylamide), 99%
Sigma-Aldrich
Remifentanil hydrochloride, ≥97% (HPLC), powder
Sigma-Aldrich
N,N′-Methylenebisacrylamide, powder, for molecular biology, suitable for electrophoresis, ≥99.5%
Sigma-Aldrich
N,N′-Methylenebisacrylamide, suitable for electrophoresis (after filtration or allowing insolubles to settle)
Propofol, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
2,6-Diisopropylphenol, 97%
Sigma-Aldrich
N,N′-Methylenebisacrylamide solution, suitable for electrophoresis, 2% in H2O
Supelco
2,6-Diisopropylphenol, analytical standard
Propofol for peak identification, European Pharmacopoeia (EP) Reference Standard