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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.

Liu Y, Li M, Yang D, Zhang X, Wu A, Yao S, Xue Z, Yue Y - PLoS ONE (2015)

Bottom Line: 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).No significant differences in propofol dose and time of tracheal extubation were observed.ChiCTR ChiCTR-OOR-14005551.

View Article: PubMed Central - PubMed

Affiliation: Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, People's Republic of China.

ABSTRACT

Background: 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.

Methods: 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.

Results: 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).

Conclusion: 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.

Trial registration: ChiCTR ChiCTR-OOR-14005551.

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Related in: MedlinePlus

Two samples of the result of the trends of BIS and calculated target concentrations of propofol during anesthesia from the two groups.Two samples of the result of the trends of BIS (red lines) and calculated target concentrations of propofol (green lines) during the induction phase and maintenance phase in the two groups. The above was the closed-loop group (GS = 15.98) and the below was opened-loop group (GS = 30.11).
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pone.0123862.g004: Two samples of the result of the trends of BIS and calculated target concentrations of propofol during anesthesia from the two groups.Two samples of the result of the trends of BIS (red lines) and calculated target concentrations of propofol (green lines) during the induction phase and maintenance phase in the two groups. The above was the closed-loop group (GS = 15.98) and the below was opened-loop group (GS = 30.11).

Mentions: The mean GS were 22.21±8.50 and 27.19±15.26 in the closed-loop and opened-loop groups during the maintenance phase, respectively (p = 0.009) (Table 4 and Fig 2). With regard to the proportion of time that BIS was between 40 and 60, the higher proportions were observed in the closed-loop (84.11±9.50%), while the lower was found in the opened-loop group (79.92±13.17%) (p = 0.016) (Table 4 and Fig 3). Fig 4 is a sample of the result of the trends of BIS and calculated target concentrations of propofol in the two groups. (The original files are available as supporting information; see S1 BIS Data Report and S2 BIS Data Report.) PE, MDPE, and MDAPE were significantly lower in the closed-loop group compared with the opened-loop group. However, the Wobble scores were similar between the two groups. Over-anesthetization events were fewer in the closed-loop group compared with the opened-loop group, while only very few cases were found with insufficient anesthetization in the two groups. No patient was found with a SR>10% for at least 1 minutes in the present study.


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.

Liu Y, Li M, Yang D, Zhang X, Wu A, Yao S, Xue Z, Yue Y - PLoS ONE (2015)

Two samples of the result of the trends of BIS and calculated target concentrations of propofol during anesthesia from the two groups.Two samples of the result of the trends of BIS (red lines) and calculated target concentrations of propofol (green lines) during the induction phase and maintenance phase in the two groups. The above was the closed-loop group (GS = 15.98) and the below was opened-loop group (GS = 30.11).
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4401751&req=5

pone.0123862.g004: Two samples of the result of the trends of BIS and calculated target concentrations of propofol during anesthesia from the two groups.Two samples of the result of the trends of BIS (red lines) and calculated target concentrations of propofol (green lines) during the induction phase and maintenance phase in the two groups. The above was the closed-loop group (GS = 15.98) and the below was opened-loop group (GS = 30.11).
Mentions: The mean GS were 22.21±8.50 and 27.19±15.26 in the closed-loop and opened-loop groups during the maintenance phase, respectively (p = 0.009) (Table 4 and Fig 2). With regard to the proportion of time that BIS was between 40 and 60, the higher proportions were observed in the closed-loop (84.11±9.50%), while the lower was found in the opened-loop group (79.92±13.17%) (p = 0.016) (Table 4 and Fig 3). Fig 4 is a sample of the result of the trends of BIS and calculated target concentrations of propofol in the two groups. (The original files are available as supporting information; see S1 BIS Data Report and S2 BIS Data Report.) PE, MDPE, and MDAPE were significantly lower in the closed-loop group compared with the opened-loop group. However, the Wobble scores were similar between the two groups. Over-anesthetization events were fewer in the closed-loop group compared with the opened-loop group, while only very few cases were found with insufficient anesthetization in the two groups. No patient was found with a SR>10% for at least 1 minutes in the present study.

Bottom Line: 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).No significant differences in propofol dose and time of tracheal extubation were observed.ChiCTR ChiCTR-OOR-14005551.

View Article: PubMed Central - PubMed

Affiliation: Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, People's Republic of China.

ABSTRACT

Background: 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.

Methods: 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.

Results: 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).

Conclusion: 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.

Trial registration: ChiCTR ChiCTR-OOR-14005551.

Show MeSH
Related in: MedlinePlus