Clinical trial NCT01198639: One-year Mortality After Surgery and Low Bispectral Index
Official title: One-year Mortality According to the Method of Total Intravenous Anesthesia. A Prospective, Randomized and Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 2044
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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):

* 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.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology patient classification status I, II and III
* patients aged between 50 and 85 years old
* born in France
* surgical procedures lasting more than one hour

Exclusion Criteria:

* American Society of Anesthesiology patient classification status IV
* 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

Primary outcomes:
measure: Mortality rate during the first year following anesthesia
timeFrame: one year after anesthesia
Secondary outcomes:
measure: conduct of anesthesia (duration of anesthesia with bispectral index < 45, bispectral index < 40, bispectral index > 60, bispectral index > 65, and burst suppression ratio)
timeFrame: end of anesthesia
measure: intraoperative awareness
timeFrame: one month postoperatively
measure: patients' satisfaction in the postanesthesia care unit (nausea, vomiting, shivering)
timeFrame: end of the stay in the postanesthesia care unit
measure: postoperative complication during the hospital stay (ancillary study)
timeFrame: one month after anesthesia
measure: major medical events during the first year following anesthesia
timeFrame: one year after anesthesia
measure: relation between patients' characteristics and mortality rate during the first year following anesthesia
timeFrame: one year after anesthesia
measure: intraoperative parameters, notably hemodynamic parameters, and their relation between them and mortality rate during the first year following anesthesia
timeFrame: one year after anesthesia
measure: in-hospital and one month mortality
timeFrame: one year after anesthesia
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: CHU Victor Dupuy
city: Besançon
country: France
facility: CHU Besançon
city: Bobigny
country: France
facility: Hôpitaux Universitaires Paris-Seine St Denis CHU Avicenne
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Bourgoin-Jallieu
country: France
facility: Clinique Saint Vincent de Paul
city: Bron
country: France
facility: Hôpital Femme-Mère-Enfant
city: Chartres
country: France
facility: CH de Chartres Louis Pasteur
city: Clamart
country: France
facility: H.I.A Percy
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Coquelles
country: France
facility: Clinique des Deux Caps
city: Dijon
country: France
facility: Clinique Fontaine-lès-Dijon
city: Grenoble
country: France
facility: CHU de Grenoble
city: Levallois-Perret
country: France
facility: Institut Hospitalier Franco Britannique
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Paris
country: France
facility: HIA du Val de Grace
city: Paris
country: France
facility: HEGP
city: Poissy
country: France
facility: CHI Poissy/St Germain-en-Laye
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Mandé
country: France
facility: Hia Begin
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: CHU Rangueil
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.