title: 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.
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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ChiCTR ChiCTR-OOR-14005551.
authors.affiliation: Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, People's Republic of China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.
authors.forename: Min
authors.initials: M
authors.lastname: Li
authors.affiliation: Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.
authors.forename: Dong
authors.initials: D
authors.lastname: Yang
authors.affiliation: Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, People's Republic of China.
authors.forename: Xuena
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, People's Republic of China.
authors.forename: Anshi
authors.initials: A
authors.lastname: Wu
authors.affiliation: Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.
authors.forename: Shanglong
authors.initials: S
authors.lastname: Yao
authors.affiliation: Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.
authors.forename: Zhanggang
authors.initials: Z
authors.lastname: Xue
authors.affiliation: Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, People's Republic of China.
authors.forename: Yun
authors.initials: Y
authors.lastname: Yue
mesh_terms: D000328:Adult; D000771:Anesthesia, Intravenous / Q000379:methods*; D018686:Anesthetics, Intravenous / Q000008:administration & dosage / Q000627:therapeutic use*; D002681:China; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000008:administration & dosage / Q000627:therapeutic use*; D015742:Propofol / Q000008:administration & dosage / Q000627:therapeutic use*; D000077208:Remifentanil; D016896:Treatment Outcome
chemical_list: D018686:Anesthetics, Intravenous; D010880:Piperidines; D000077208:Remifentanil; D015742:Propofol