title: A Multicenter Evaluation of a Closed-Loop Anesthesia Delivery System: A Randomized Controlled Trial.
abstract: 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 (BIS)-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.
authors.affiliation: 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.
authors.forename: Goverdhan D
authors.initials: GD
authors.lastname: Puri
authors.forename: Preethy J
authors.initials: PJ
authors.lastname: Mathew
authors.forename: Indranil
authors.initials: I
authors.lastname: Biswas
authors.forename: Amitabh
authors.initials: A
authors.lastname: Dutta
authors.forename: Jayashree
authors.initials: J
authors.lastname: Sood
authors.forename: Satinder
authors.initials: S
authors.lastname: Gombar
authors.forename: Sanjeev
authors.initials: S
authors.lastname: Palta
authors.forename: Morup
authors.initials: M
authors.lastname: Tsering
authors.forename: P L
authors.initials: PL
authors.lastname: Gautam
authors.forename: Aveek
authors.initials: A
authors.lastname: Jayant
authors.forename: Inderjeet
authors.initials: I
authors.lastname: Arora
authors.forename: Vishal
authors.initials: V
authors.lastname: Bajaj
authors.forename: T S
authors.initials: TS
authors.lastname: Punia
authors.forename: Gurjit
authors.initials: G
authors.lastname: Singh
mesh_terms: D000328:Adult; D000768:Anesthesia, General / Q000009:adverse effects / Q000295:instrumentation*; D000771:Anesthesia, Intravenous / Q000009:adverse effects / Q000295:instrumentation*; D018686:Anesthetics, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects; D062186:Arterial Pressure / Q000187:drug effects; D001331:Automation; D003243:Consciousness / Q000187:drug effects*; D056805:Consciousness Monitors; D004334:Drug Administration Schedule; D016503:Drug Delivery Systems / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007194:India; D007262:Infusions, Intravenous; D064795:Intraoperative Neurophysiological Monitoring / Q000295:instrumentation; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D011237:Predictive Value of Tests; D015742:Propofol / Q000008:administration & dosage* / Q000009:adverse effects; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018686:Anesthetics, Intravenous; D015742:Propofol