One-year Mortality After Surgery and Low Bispectral Index
ELA
One-year Mortality According to the Method of Total Intravenous Anesthesia. A Prospective, Randomized and Multicenter Study
1 other identifier
interventional
2,044
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2010
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2010
CompletedFirst Posted
Study publicly available on registry
September 10, 2010
CompletedStudy Start
First participant enrolled
September 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2015
CompletedFebruary 15, 2018
February 1, 2018
3.4 years
September 9, 2010
February 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality rate during the first year following anesthesia
one year after anesthesia
Secondary Outcomes (8)
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
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
- +3 more secondary outcomes
Study Arms (2)
manual administration of iv anesthetics
ACTIVE COMPARATORclosed-loop administration of iv anesthetics
EXPERIMENTALInterventions
the anesthesiologists are instructed to maintain the BIS values between 40 and 60 throughout anesthesia using target controlled infusion method
an algorithm is used to maintain automatically the BIS values between 40 and 60
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (22)
CHU Victor Dupuy
Argenteuil, 95107, France
CHU Besançon
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
Related Publications (5)
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.
PMID: 16571963BACKGROUNDCantraine 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.
PMID: 12578088BACKGROUNDLindholm 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.
PMID: 19151279RESULTMonk 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.
PMID: 15616043RESULTMahr 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.
PMID: 33181558DERIVED
Study Officials
- STUDY CHAIR
Marc Fischler, MD
Hôpital Foch
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2010
First Posted
September 10, 2010
Study Start
September 13, 2010
Primary Completion
February 20, 2014
Study Completion
February 20, 2015
Last Updated
February 15, 2018
Record last verified: 2018-02