One-year Mortality After Surgery and Low Bispectral Index

Not Applicable

Completed

• Conditions: General Anesthesia
• Interventions: Device: manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform; Device: closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform

• Registration Number: NCT01198639
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Study Start: 2010-09-13
• Primary Completion: 2014-02-20
• Study Completion: 2015-02-20
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-14
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2044

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
manual administration of iv anesthetics	manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform	-
closed-loop administration of iv anesthetics	closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform	-

Primary Outcome Measures

Name	Time	Method
Mortality rate during the first year following anesthesia	one year after anesthesia

Secondary Outcome Measures

Name	Time	Method
in-hospital and one month mortality	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
intraoperative awareness	one month postoperatively
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
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

Trial Locations

Locations (22)

Hia Begin; 🇫🇷 Saint-Mandé, France

Institut Paoli-Calmettes; 🇫🇷 Marseille, France

CH de Chartres Louis Pasteur; 🇫🇷 Chartres, France

H.I.A Percy; 🇫🇷 Clamart, France

Institut Hospitalier Franco Britannique; 🇫🇷 Levallois-Perret, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHI Poissy/St Germain-en-Laye; 🇫🇷 Poissy, France

HEGP; 🇫🇷 Paris, France

CHU Besançon; 🇫🇷 Besançon, France

Clinique Fontaine-lès-Dijon; 🇫🇷 Dijon, France

Hôpital Foch; 🇫🇷 Suresnes, France

CHU Rangueil; 🇫🇷 Toulouse, France

CHU Victor Dupuy; 🇫🇷 Argenteuil, France

CHU de Rouen; 🇫🇷 Rouen, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Clinique des Deux Caps; 🇫🇷 Coquelles, France

CHU Tours; 🇫🇷 Tours, 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

HIA du Val de Grace; 🇫🇷 Paris, France