One-year Mortality After Surgery and Low Bispectral Index
NCT ID: NCT01198639
Last Updated: 2018-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2044 participants
INTERVENTIONAL
2010-09-13
2015-02-20
Brief Summary
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* manual administration: the anesthesiologists are instructed to maintain the BIS value between 40 and 60.
* closed loop administration: an algorithm is used to maintain the BIS value between 40 and 60.
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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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manual administration of iv anesthetics
manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform
the anesthesiologists are instructed to maintain the BIS values between 40 and 60 throughout anesthesia using target controlled infusion method
closed-loop administration of iv anesthetics
closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform
an algorithm is used to maintain automatically the BIS values between 40 and 60
Interventions
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manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform
the anesthesiologists are instructed to maintain the BIS values between 40 and 60 throughout anesthesia using target controlled infusion method
closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform
an algorithm is used to maintain automatically the BIS values between 40 and 60
Eligibility Criteria
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Inclusion Criteria
* patients aged between 50 and 85 years old
* born in France
* surgical procedures lasting more than one hour
Exclusion Criteria
* patients born out of France
* pace-maker
* surgical procedure on the skull or avoiding an adequate positioning of the bispectral index electrode dementia, history of central nervous system disease (tumor, vascular event, Parkinson disease, ...)
* psychiatric illness (severe depression or psychosis), patients receiving a psychotropic treatment
* anesthesia performed during the year before inclusion in this study except for diagnostic procedures
* allergy to propofol, soja, peanuts, or to sufentanil, remifentanil, or morphine, to a myorelaxant or to an excipient,
* hypersensibility to sufentanil, to remifentanil, or to other derivate of fentanyl
50 Years
85 Years
ALL
No
Sponsors
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Hopital Foch
OTHER
Responsible Party
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Principal Investigators
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Marc Fischler, MD
Role: STUDY_CHAIR
Hôpital Foch
Locations
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CHU Victor Dupuy
Argenteuil, , France
CHU Besançon
Besançon, , France
Hôpitaux Universitaires Paris-Seine St Denis CHU Avicenne
Bobigny, , 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, , France
Clinique Fontaine-lès-Dijon
Dijon, , France
CHU de Grenoble
Grenoble, , France
Institut Hospitalier Franco Britannique
Levallois-Perret, , France
Institut Paoli-Calmettes
Marseille, , France
HIA du Val de Grace
Paris, , France
HEGP
Paris, , France
CHI Poissy/St Germain-en-Laye
Poissy, , France
CHU de Rouen
Rouen, , France
Hia Begin
Saint-Mandé, , France
Hôpital Foch
Suresnes, , France
CHU Rangueil
Toulouse, , France
CHU Tours
Tours, , France
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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2009/30
Identifier Type: -
Identifier Source: org_study_id
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