A randomized controlled trial demonstrates that a novel closed-loop propofol system performs better hypnosis control than manual administration Une étude randomisée contrôlée démontre qu'un système innovant d'administration de propofol en circuit fermé permet un meilleur contrôle de l'hypnose qu'une administration manuelle Abstract Purpose The purpose of this randomized control trial was to determine the performance of a novel rule-based adaptive closed-loop system for propofol administration using the bispectral index (BISÒ) and to compare the system's performance with manual administration. The effectiveness of the closed-loop system to maintain BIS close to a target of 45 was determined and compared with manual administration. Methods After Institutional Review Board approval and written consent, 40 patients undergoing major surgery in a tertiary university hospital were allocated to two groups using computer-generated block randomization. In the Closed-loop group (n = 20), closed-loop control was used to maintain anesthesia at a target BIS of 45, and in the Control group (n = 20), propofol was administered manually to maintain the same BIS target. To evaluate each technique's performance in maintaining a steady level of hypnosis, the BIS values obtained during the surgical procedure were stratified into four clinical performance categories relative to the target BIS: B 10%, 11-20%, 21-30%, or [ 30% defined as excellent, good, poor, or inadequate control of hypnosis, respectively. The controller performance was compared using Varvel's controller performance indices. Data were compared using Fisher's exact test and the Mann-Whitney U test, P \ 0.05 showing statistical significance. Results In the Closed-loop group, four females and 16 males (aged 54 ± 20 yr; weight 79 ± 7 kg) underwent anesthesia lasting 143 ± 57 min. During 55%, 29%, 9%, and 7% of the total anesthesia time, the system showed excellent, good, poor, and inadequate control, respectively. In the Control group, five females and 15 males (aged 59 ± 16 yr; weight 75 ± 13 kg) underwent anesthesia lasting 157 ± 81 min. Excellent, good, poor, and inadequate control were noted during 33%, 33%, 15%, and 19% of the total anesthesia time, respectively. In the This work was presented as an abstract at the annual meeting of the Society of Technology in Anesthesia in San Diego in January 2008. The abstract won the Excellence in Technology Innovation Award. Dr. Hemmerling is the inventor of the McSleepy(R) system, which is an automated system that integrates all three components of anesthesia -hypnosis, analgesia, and muscle relaxation. This system is patent pending; however, the ''loop'' for propofol administration within McSleepy is different from the propofol administration loop used in the present manuscript. Closed-loop group, excellent control of anesthesia occurred significantly more often (P \ 0.0001), and poor and inadequate control occurred less often than in the Control group (P \ 0.01). The median performance error and the median absolute performan...
<p class="MsoNormal" style="text-align: left; margin: 0cm 0cm 0pt; layout-grid-mode: char;" align="left"><span class="text"><em><span style="font-family: ";Arial";,";sans-serif";; font-size: 9pt;">Purpose</span></em></span><span class="text"><span style="font-family: ";Arial";,";sans-serif";; font-size: 9pt;">. Measuring pain during general anesthesia is difficult because communication with the patient is impossible. The focus of this project is the evaluation of an objective score (‘Analgoscore’</span></span><span style="font-family: ";Arial";,";sans-serif";; font-size: 9pt;"> </span><span class="text"><span style="font-family: ";Arial";,";sans-serif";; font-size: 7.5pt;">TM</span></span><span class="text"><span style="font-family: ";Arial";,";sans-serif";; font-size: 9pt;">) of intraoperative nociception based on mean arterial pressure (MAP) and heart rate (HR). The Analgoscore is used for closed-loop application of remifentanil.</span></span></p><p class="MsoNormal" style="text-align: left; margin: 0cm 0cm 0pt; layout-grid-mode: char;" align="left"><span class="text"><em><span style="font-family: ";Arial";,";sans-serif";; font-size: 9pt;">Methods</span></em></span><span class="text"><span style="font-family: ";Arial";,";sans-serif";; font-size: 9pt;">. The Analgoscore ranges from -9 (too profound analgesia) to 9 (too superficial analgesia) in increments of 1, with -3 to +3 representing excellent pain control, -3 to -6 and 3 to 6 good pain control, and -6 to -9 and 6 to 9 insufficient pain control. According to the zone of pain, a remifentanil infusion was either closed-loopadministered (Closed-loop-group) or manually administered by the same anesthesiologist (Control group). The percentage of anesthetic time within the different control zones was recorded as well as the variability of MAP and HR and compared between the two groups. Data presented as means ± standard deviation.</span></span></p><p class="MsoNormal" style="text-align: left; margin: 0cm 0cm 0pt; layout-grid-mode: char;" align="left"><span class="text"><em><span style="font-family: ";Arial";,";sans-serif";; font-size: 9pt;">Results</span></em></span><span class="text"><span style="font-family: ";Arial";,";sans-serif";; font-size: 9pt;">. In the closed-loop group, 16 patients (5 f, 11 m; age 49 ± 21 y) underwent anesthesia of 111 ± 44 min, and received a dose of remifentanil of 0.13 ± 0.08 μg/kg/min. During 84%, 14% and 0.5% of the total anesthesia time, the Analgoscore showed excellent, good or insufficient pain control, respectively. During 70% of the time, MAP ranged from -5% to 5%, during 21% of the time it ranged from - 10% to -5% and from 5% to 10% and during 9% of the time, it ranged from -20% to -10% and from 10% to 20% below or above the target values. Heart rate was within 10% of targe...
A mixed numerical-graphical display design appears to present the best results in terms of user reaction times, response accuracy, and performance index when detecting abnormal critical events.
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