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Randomized Controlled Trial
Feasibility of Closed-loop Titration of Propofol and Remifentanil Guided by the Bispectral Monitor in Pediatric and Adolescent Patients: A Prospective Randomized Study.
Closed loop control of propofol/remi TIVA targeting BIS 40-60 is more precise than manual control.
pearl- Gilles A Orliaguet, Fatema Benabbes Lambert, Thierry Chazot, Pauline Glasman, Marc Fischler, and Ngai Liu.
- From the Service d'Anesthésie Réanimation, Hôpital Universitaire Necker-Enfants Malades, Université Paris Descartes, Assistance Publique-Hôpitaux de Paris, Paris, France (G.A.O., F.B.L., P.G.); Service d'Anesthésie Réanimation, Hôpital Foch, Suresnes, France (T.C., M.F., N.L.); and the Outcomes Research Consortium, Cleveland Clinic, Cleveland, Ohio (N.L.).
- Anesthesiology. 2015 Apr 1;122(4):759-67.
BackgroundThis study was designed to assess the feasibility of dual closed-loop titration of propofol and remifentanil guided solely by the Bispectral Index (BIS) monitor in pediatric and adolescent patients during anesthesia.MethodsChildren undergoing elective surgery in this single-blind randomized study were allocated into the closed-loop (auto) or manual (manual) group. Primary outcome was the percentage of time with the BIS in the range 40 to 60 (BIS40-60). Secondary outcomes were the percentage of deep (BIS<40) anesthesia and drug consumption. Data are presented as median (interquartile range) or number (%).ResultsTwenty-three patients (12 [10 to 14] yr) were assigned to the auto group and 19 (14 [7 to 14] yr) to the manual group. The closed-loop controller was able to provide induction and maintenance for all patients. The percentage of time with BIS40-60 was greater in the auto group (87% [75 to 96] vs. 72% [48 to 79]; P = 0.002), with a decrease in the percentage of BIS<40 (7% [2 to 17] vs. 21% [11 to 38]; P = 0.002). Propofol (2.4 [1.9 to 3.3] vs. 1.7 [1.2 to 2.8] mg/kg) and remifentanil (2.3 [2.0 to 3.0] vs. 2.5 [1.2 to 4.3] μg/kg) consumptions were similar in auto versus manual groups during induction, respectively. During maintenance, propofol consumption (8.2 [6.0 to 10.2] vs. 7.9 [7.2 to 9.1] mg kg h; P = 0.89) was similar between the two groups, but remifentanil consumption was greater in the auto group (0.39 [0.22 to 0.60] vs. 0.22 [0.17 to 0.32] μg kg min; P = 0.003). Perioperative adverse events and length of stay in the postanesthesia care unit were similar.ConclusionIntraoperative automated control of hypnosis and analgesia guided by the BIS is clinically feasible in pediatric and adolescent patients and outperformed skilled manual control.
This article appears in the collection: Closed-loop anesthesia delivery.
Notes
The flaw with many closed loop TIVA-BIS studies, such as this one, is that they unquestionably assume reliability of BIS and are not powered for important morbidity or mortality outcomes.
This study while professing to show 'superiority' of a closed-loop system, really just shows that when given a monitor target the algorithm can more accurately and rapidly adjust the TIVA to maintain this. This may well be a good outcome, but does not necessarily equate to 'good' or safe anesthesia.
It's important to note that BIS has been validated essentially as an awareness alarm, not (yet) as a guide to appropriate depth of anesthesia.
Daniel Jolley
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