Evaluation of a closed-loop intravenous total anesthesia delivery system with BIS monitoring compared to an open-loop target-controlled infusion (TCI) system: randomized controlled clinical trial
Intravenous general anesthesia is an anesthetic technique that can be administered with TCI (target-controlled infusion) or closed-loop systems. The authors designed an automatic delivery system using clinical variables such as bispectral index (BIS), heart rate, and blood pressure.
To evaluate the clinical and technical performance of this controller by comparing it to a TCI system.
This was a single-blind, randomized, controlled clinical trial in which 150 patients were recruited: 75 for the TCI group and 75 for the closed loop with BIS. Clinical performance was determined according to the mean percentage of time spent in the BIS range of 40 to 60 during anesthetic maintenance. In addition, adequate intraoperative analgesia, technical performance, intraoperative awakening, and intraoperative recall were evaluated.
The primary outcome showed a mean BIS time between 40 and 60 for the closed loop of 75.24% (± 15.78) versus 59.5% (± 20.3) for the TCI system, with an absolute difference of 15.8%, 95% confidence interval (CI): 9.9 to 21.65, P < 0.0001. The mean time in intraoperative analgesia was 82.4% (25.1) in closed loop and 70.77% (± 32.8) in TCI, with a difference of 4.76 (95% CI: 2.23-21.06), P = 0.016. There was no difference in intraoperative recall.
The closed-loop system was better at maintaining a BIS in the range of 40 to 60 during a general anesthetic than the open system or TCI.
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