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A correlation between deep anesthesia (defined as time with Bispectral Index (BIS) lower than 45) and death within 1 yr after surgery has previously been reported. In order to confirm or refute these findings, the investigators have designed a study which compares two methods of administration for total intravenous anesthesia (propofol and remifentanil):
Based on previous studies, the amount of time that BIS is maintained above 40 is greater when anesthetics agents are administered using closed loop compared with manual administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| manual administration of iv anesthetics | Active Comparator |
| |
| closed-loop administration of iv anesthetics | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform | Device | the anesthesiologists are instructed to maintain the BIS values between 40 and 60 throughout anesthesia using target controlled infusion method |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate during the first year following anesthesia | one year after anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| conduct of anesthesia (duration of anesthesia with bispectral index < 45, bispectral index < 40, bispectral index > 60, bispectral index > 65, and burst suppression ratio) | end of anesthesia | |
| intraoperative awareness | one month postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Fischler, MD | Hôpital Foch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Victor Dupuy | Argenteuil | 95107 | France | |||
| CHU Besançon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16571963 | Background | Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012. | |
| 12578088 |
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| closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform | Device | an algorithm is used to maintain automatically the BIS values between 40 and 60 |
|
| patients' satisfaction in the postanesthesia care unit (nausea, vomiting, shivering) | end of the stay in the postanesthesia care unit |
| postoperative complication during the hospital stay (ancillary study) | one month after anesthesia |
| major medical events during the first year following anesthesia | one year after anesthesia |
| relation between patients' characteristics and mortality rate during the first year following anesthesia | one year after anesthesia |
| intraoperative parameters, notably hemodynamic parameters, and their relation between them and mortality rate during the first year following anesthesia | one year after anesthesia |
| in-hospital and one month mortality | one year after anesthesia |
| Besançon |
| 25030 |
| France |
| Hôpitaux Universitaires Paris-Seine St Denis CHU Avicenne | Bobigny | 93000 | France |
| Clinique Saint Augustin | Bordeaux | France |
| Clinique Saint Vincent de Paul | Bourgoin | France |
| Hôpital Femme-Mère-Enfant | Bron | France |
| CH de Chartres Louis Pasteur | Chartres | France |
| H.I.A Percy | Clamart | France |
| Centre Jean Perrin | Clermont-Ferrand | France |
| Clinique des Deux Caps | Coquelles | 62231 | France |
| Clinique Fontaine-lès-Dijon | Dijon | 21121 | France |
| CHU de Grenoble | Grenoble | 38700 | France |
| Institut Hospitalier Franco Britannique | Levallois-Perret | France |
| Institut Paoli-Calmettes | Marseille | France |
| HIA du Val de Grace | Paris | 75005 | France |
| HEGP | Paris | 75908 | France |
| CHI Poissy/St Germain-en-Laye | Poissy | 78303 | France |
| CHU de Rouen | Rouen | 76000 | France |
| Hia Begin | Saint-Mandé | 94163 | France |
| Hôpital Foch | Suresnes | 92151 | France |
| CHU Rangueil | Toulouse | 31403 | France |
| CHU Tours | Tours | 37044 | France |
| Cantraine FR, Coussaert EJ. The first object oriented monitor for intravenous anesthesia. J Clin Monit Comput. 2000 Jan;16(1):3-10. doi: 10.1023/a:1009904805940. |
| 19151279 | Result | Lindholm ML, Traff S, Granath F, Greenwald SD, Ekbom A, Lennmarken C, Sandin RH. Mortality within 2 years after surgery in relation to low intraoperative bispectral index values and preexisting malignant disease. Anesth Analg. 2009 Feb;108(2):508-12. doi: 10.1213/ane.0b013e31818f603c. |
| 15616043 | Result | Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E. |
| 33181558 | Derived | Mahr N, Bouhake Y, Chopard G, Liu N, Boichut N, Chazot T, Claveau M, Vettoretti L, Tio G, Pili-Floury S, Samain E, Besch G. Postoperative Neurocognitive Disorders After Closed-Loop Versus Manual Target Controlled-Infusion of Propofol and Remifentanil in Patients Undergoing Elective Major Noncardiac Surgery: The Randomized Controlled Postoperative Cognitive Dysfunction-Electroencephalographic-Guided Anesthetic Administration Trial. Anesth Analg. 2021 Oct 1;133(4):837-847. doi: 10.1213/ANE.0000000000005278. |