One-year Mortality After Surgery and Low Bispectral Index

General Anesthesia Clinical Trial

— ELA  

Official title:

One-year Mortality According to the Method of Total Intravenous Anesthesia. A Prospective, Randomized and Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198639
• Other study ID #: 2009/30
• Status: Completed
• Phase: N/A
• First received: September 9, 2010
• Last updated: February 14, 2018
• Start date: September 13, 2010
• Est. completion date: February 20, 2015

Study information

• Verified date: February 2018
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2044
• Est. completion date: February 20, 2015
• Est. primary completion date: February 20, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Device:
• 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

Locations

Country	Name	City	State
France	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-Jallieu
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	HEGP	Paris
France	HIA du Val de Grace	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

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (4)

Cantraine FR, Coussaert EJ. The first object oriented monitor for intravenous anesthesia. J Clin Monit Comput. 2000 Jan;16(1):3-10. — View Citation

Lindholm ML, Träff 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: — View Citation

Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate during the first year following anesthesia		one year after anesthesia
Secondary	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
Secondary	intraoperative awareness		one month postoperatively
Secondary	patients' satisfaction in the postanesthesia care unit (nausea, vomiting, shivering)		end of the stay in the postanesthesia care unit
Secondary	postoperative complication during the hospital stay (ancillary study)		one month after anesthesia
Secondary	major medical events during the first year following anesthesia		one year after anesthesia
Secondary	relation between patients' characteristics and mortality rate during the first year following anesthesia		one year after anesthesia
Secondary	intraoperative parameters, notably hemodynamic parameters, and their relation between them and mortality rate during the first year following anesthesia		one year after anesthesia
Secondary	in-hospital and one month mortality		one year after anesthesia