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A Multicenter Evaluation of a Closed-Loop Anesthesia Delivery System: A Randomized Controlled Trial

Puri, Goverdhan D. MD, PhD*; Mathew, Preethy J. MD*; Biswas, Indranil MD*; Dutta, Amitabh MD; Sood, Jayashree PGDHHM, FFARCS, MD, MBBS, FICA; Gombar, Satinder MD; Palta, Sanjeev MD; Tsering, Morup MD§; Gautam, P. L. MD; Jayant, Aveek MD, DM*; Arora, Inderjeet MSc*; Bajaj, Vishal MD; Punia, T. S. MD; Singh, Gurjit MSc#

doi: 10.1213/ANE.0000000000000769
Technology, Computing, and Simulation: Research Report

BACKGROUND: Closed-loop systems for anesthesia delivery have been shown to outperform traditional manual control in different clinical settings. The present trial was aimed at evaluating the feasibility and efficacy of Bispectral Index (BISTM)-guided closed-loop anesthesia delivery system (CLADS) in comparison with manual control across multiple centers in India.

METHODS: Adult patients scheduled for major surgical procedures of an expected duration of 1 to 3 hours were randomized across 6 sites into 2 groups: a CLADS group and a manual group. In the manual control group, propofol infusion was titrated manually by the attending anesthesiologist to a BIS of 50 during induction and maintenance. Analgesia was maintained with fentanyl infusion and nitrous oxide in both groups. In the CLADS group, both induction and maintenance of anesthesia were performed automatically using CLADS. The primary outcome measure was the performance of the system as assessed by the percentage of total anesthesia time BIS remained ±10 of target BIS. The secondary outcome measures were a percentage of anesthesia-time heart rate and mean arterial pressure within 25% of the baseline, median absolute performance error, wobble, and global score. Wobble indicates intraindividual variability in the control of BIS, and global score reflects the overall performance; lower values indicate superior performance for both parameters. The performance parameters of the system also were compared among the participating sites.

RESULTS: Two hundred forty-two patients were randomized. BIS was maintained within ±10 of target for significantly longer time in the CLADS group (81.4% ± 8.9 % of anesthesia duration) than in the manual group (55.34% ± 25%, P < 0.0001). The indices that assess performance were significantly better in the CLADS group than the manual group as follows: median absolute performance error was 10 (10, 12) (median [interquartile range]) in the CLADS group versus 18 (14, 24) in the manual group, P < 0.0001; wobble was 9 (8, 10) in CLADS group versus 10 (8, 14) in the manual group, P = 0.0009; and Global score, which reflects overall performance, was 24 (19, 30) in the CLADS group versus 51 (31, 99) in the manual group, P < 0.0001. The percentage of time heart rate was within 25% of the baseline was significantly greater in the CLADS group (heart rate of 95 [87, 99], median [interquartile range], in the CLADS group versus 90 [75, 98] in the manual group P = 0.0031). On comparison of data between the centers, the performance parameters did not differ significantly among the centers in the CLADS group (P = 0.94), but the parameters differed significantly among the centers in the manual group (P < 0.001).

CONCLUSIONS: Our study in a multicenter setting proves the consistently better performance of automated anesthesia drug delivery compared with conventional manual control. This highlights an important advantage of an automated system for delivering standardized anesthesia, thereby overcoming differences in practices among anesthesiologists.

Published ahead of print April 21, 2015

From the *Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India; Department of Anesthesia, Sir Ganga Ram Hospital, New Delhi, India; Department of Anesthesia, Government Medical College and Hospital, Chandigarh, India; §Department of Anesthesia, Sonam Norbu M Hospital, Leh, Jammu & Kashmir, India; Department of Anesthesia, Dayanand Medical College, Ludhiana, India; Department of Anesthesia, Government Medical College and Hospital, Patiala, Punjab, India; and #National Institute of Electronics and Information Technology (NIELIT), Itanagar, Arunachal Pradesh, India.

Accepted for publication January 5, 2015.

Published ahead of print April 21, 2015

Funding: This work was funded by: Department of Information Technology, Government of India, New Delhi.

The authors declare no conflicts of interest.

Reprints will not be available from the authors.

Address correspondence to Goverdhan D. Puri, MD, PhD, Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India. Address e-mail to gdpuri007@hotmail.com.

© 2016 International Anesthesia Research Society