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Background: The aim of the study was to investigate whether closed-loop compared to manual bispectral index (BIS)-guided target-controlled infusion of propofol and remifentanil could decrease the incidence of postoperative neurocognitive disorders after elective major noncardiac surgery., Methods: Patients aged >50 admitted for elective major noncardiac surgery were included in a single-blind randomized (ratio 2:1) trial. The anesthetic protocol was allocated by randomization into either closed-loop or manual BIS-guided propofol and remifentanil titration. The BIS target range was 40-60. All patients had cognitive assessment the day before surgery and within 72 hours after surgery using a battery of neuropsychological tests. The primary outcome was the rate of postoperative neurocognitive disorders. Postoperative neurocognitive disorders were defined as a decrease >20% from baseline on at least 3 scores. Intergroup comparison of the primary outcome was performed using the χ2 test., Results: A total of 143 and 61 patients were included in the closed-loop and manual groups, respectively (age: 66 [8] vs 66 [9] years). The primary outcome was observed in 18 (13%) and 10 (16%) patients of the closed-loop and manual groups, respectively (relative risk [95% confidence interval {CI}], 0.77 [0.38-1.57], P = .47). Intraoperative propofol consumption was lower (4.7 [1.4] vs 5.7 [1.4] mg·kg-1·h-1, mean difference [MD] [95% CI], -0.73 [-0.98 to -0.48], P < .0001) and the proportion of time within the BIS target range higher (84 [77-89] vs 74 [54-81]%, MD [95% CI], 0.94 [0.67-1.21], P < .0001) in the closed-loop group., Conclusions: Closed-loop compared to manual BIS-guided total intravenous anesthesia provided a significant reduction in episodes of an excessive depth of anesthesia while decreasing intraoperative propofol requirement but no evidence for a reduction of the incidence of postoperative neurocognitive disorders after elective major noncardiac surgery was observed., Competing Interests: Conflicts of Interest: See Disclosures at the end of the article., (Copyright © 2020 International Anesthesia Research Society.)

Introduction: Post-operative cognitive dysfunction (POCD) is frequent in patients older than 60 years undergoing major non-cardiac surgery, and increases both morbidity and mortality. Anesthetic drugs may exert neurotoxic effects and contribute to the genesis of POCD. The hypothesis of the POCD-ELA trial was that closed-loop target-controlled infusion of propofol and remifentanil could reduce the occurrence of POCD by decreasing the risk of excessive depth of anesthesia and the dose of anesthetic drugs., Methods and Analysis: We designed a single-center, single-blind, randomized, controlled, parallel trial and aim to include 204 patients aged >60 years undergoing elective major non-cardiac surgery. Patients will be randomized to receive closed-loop versus manual target-controlled infusion of propofol and remifentanil guided by bispectral index monitoring. Cognitive assessment will be performed the day before surgery (baseline) and within 72 hours after surgery, using a battery of validated neuropsychological tests. The primary outcome is the incidence of POCD within 72 hours after surgery. POCD is defined as a Z-score value > 1.96 for at least 2 different tests or a Z-score composite value >1.96. The calculation of the Z-score is based on data from an age-matched control population who did not undergo surgery or general anesthesia., Ethics and Dissemination: This study was approved by the Ethics Committee (Comité de Protection des Personnes Est-II) and authorized by the French Health Products Agency (Agence Nationale de Sécurité des Médicaments, Saint-Denis, France). The University Hospital of Besancon is the trial sponsor and the holder of all data and publication rights. Results of the study will be submitted for publication in a peer-review international medical journal and for presentation in abstract (oral or poster) in international peer-reviewed congresses., Registration: The trial is registered with ClinicalTrials.gov (Identifier: NCT02841423, principal investigator: Prof Emmanuel Samain, date of registration: July 22, 2016). Last amendment of protocol: version 8.0 April 2018.

Background: Currently, patients older than 60 years of age represent 25% of the population and are at an increased risk during surgery. Therefore, reducing postoperative morbidity and mortality is a major concern in medical research and practice. Dependence on caregivers and cognitive impairment represent two major risk factors in the elderly, especially in frail patients after surgery under general anesthesia. In this context, continuous monitoring of the depth of anesthesia using a bispectral index (BIS) sensor may reduce the occurrence of impairments by gaining better control of the anesthetic depth. The first aim of this study is to compare manual versus automated administration of intravenous anesthetics with regard to 6-month functional decline in persons aged 70 years and older. The secondary objective includes an evaluation of the influence of the frail phenotype on self-sufficiency in elderly patients after general anesthesia., Methods/design: After receiving ethical committee approval and written consent, a complete preoperative assessment of physiological reserve and self-sufficiency will be performed on patients more than 70 years old who are scheduled for surgery under general anesthesia. This evaluation will determine the patient's frailty status in three categories: robust, pre-frail, and frail. Then, patients will be randomized into two groups: manual administration of anesthetics guided by BIS sensor (manual group) or automated administration (automated group) with recording of the anesthesia. A second examination will be scheduled after 6 months to assess changes in functional abilities, cognitive functions, and frailty status. A priori calculation of sample size gives a population of 430 patients to be included in this multicenter trial., Discussion: This clinical study is designed to detect any postoperative complications and deaths related to the performance of the general anesthesia guided by the BIS sensor and the preoperative functional status of the elderly: robust, pre-frail, or frail., Trial Registration: ClinicalTrials.gov, NCT02524327 . Registered on 10 August 2015.

Background: Nitrous oxide (N2O) offers both hypnotic and analgesic characteristics. We therefore tested the hypothesis that N2O administration decreases the amount of propofol and remifentanil given by a closed-loop automated controller to maintain a similar bispectral index (BIS)., Methods: In a randomized multicentre double-blind study, patients undergoing elective surgery were randomly assigned to breathe 60% inspired N2O (N2O group) or 40% oxygen (AIR group). Anaesthesia depth was evaluated by the proportion of time where BIS was within the range of 40-60 (BIS40-60). The primary outcomes were propofol and remifentanil consumption, with reductions of 20% in either being considered clinically important., Results: A total of 302 patients were randomized to the N2O group and 299 to the AIR group. At similar BIS40-60 [79 (67-86)% vs 76 (65-85)%], N2O slightly decreased propofol consumption [4.5 (3.7-5.5) vs 4.8 (4.0-5.9) mg kg(-1) h(-1), P=0.032], but not remifentanil consumption [0.17 (0.12-0.23) vs 0.18 (0.14-0.24) µg kg(-1) min(-1)]. For the subgroups of men, at similar BIS40-60 [80 (72-88)% vs 80 (70-87)%], propofol [4.2 (3.4-5.3) vs 4.4 (3.6-5.4) mg kg(-1) h(-1)] and remifentanil [0.19 (0.13-0.25) vs 0.18 (0.15-0.23) µg kg(-1) min(-1)] consumptions were similar in the N2O vs AIR group, respectively. For the subgroups of women, at similar BIS40-60 [76 (64-84)% vs 72 (62-82)%], propofol [4.7 (4.0-5.8) vs 5.3 (4.5-6.6) mg kg(-1) h(-1), P=0.004] and remifentanil [0.18 (0.13-0.25) vs 0.20 (0.15-0.27) µg kg(-1) min(-1), P=0.029] consumptions decreased with the co-administration of N2O., Conclusions: With automated drug administration titrated to comparable BIS, N2O only slightly reduced propofol consumption and did not reduce remifentanil consumption. There was a minor gender dependence, but not by a clinically important amount. Clinical trial registration This study was registered at ClinicalTrials.gov, number NCT00547209.

Background: We have developed a proportional-integral-derivative controller allowing the closed-loop coadministration of propofol and remifentanil, guided by a Bispectral Index (BIS) monitor, during induction and maintenance of general anesthesia. The controller was compared with manual target-controlled infusion., Methods: In a multicenter study, 196 surgical patients were randomly assigned to dual closed-loop or manual administration of propofol and remifentanil. Comparison between groups was evaluated by calculating a global score that characterized the overall performance of the controller including the percentage of adequate anesthesia, defined as BIS between 40 and 60, the median absolute performance error, and wobble. Secondary outcomes included occurrence of burst suppression ratio, time to tracheal extubation, and drug consumption., Results: Eighty-three patients assigned to dual-loop control and 84 patients assigned to manual control completed the study. The global score and the percentage of time with BIS between 40 and 60 were better in the dual-loop group (26 ± 11 vs 43 ± 40, P < 0.0001; 82% ± 12% vs 71% ± 19%, P < 0.0001). Overshoot (BIS <40), undershoot (BIS >60), and burst suppression ratio were all significantly less common in the dual-loop group. Modifications to the propofol and remifentanil infusions were more frequent, and adjustments smaller in the dual-loop group. Remifentanil consumption was greater (0.22 ± 0.07 vs 0.16 ± 0.07 μg · kg(-1) · min(-1); P < 0.0001) and the speed to tracheal extubation was shorter (10 ± 4 vs 11 ± 5 minutes; P = 0.02) in the dual-loop group., Conclusion: The controller allows the automated delivery of propofol and remifentanil and maintains BIS values in predetermined boundaries during general anesthesia better than manual administration.

Background: The aim of this study was to describe topographic variations in the arrangement of the four main brachial plexus nerves at the junction of the axilla and the upper part of the arm., Methods: In 153 patients undergoing upper arm surgery using axillary block, we studied nerve arrangements with a three-step approach, combining: (A) cross-sectional ultrasound imaging using a 12 MHz linear ultrasound probe; (B) distal shift of the ultrasound scanhead from the axilla to the elbow joint following the paths of individual nerves; and (C) identifying the distal motor response to electrical nerve stimulation of each nerve. These results were then converted into a 12-section pie chart with the axillary artery (AA) as the axis., Results: The order of the nerves around the AA was median, ulnar, radial, and musculocutaneous in all cases. The most frequent arrangement was observed in 65% of the patients. Five less frequent variations were observed in 4-20% of the patients, with four other variations seen in <2% of the patients. In 78% of the cases, the four nerves were seen separately using static ultrasound imaging. The musculocutaneous nerve was close to the artery in 18% of the patients., Conclusions: Topographic variations of the four main nerves at the axilla were found to be numerous, the most frequent arrangement being seen in less than two-thirds of the patients. Four separate nerves were seen on static ultrasound imaging at this sectional level of the axilla in only 78% of the cases.