One-year Mortality After Surgery and Low Bispectral Index

N/ACompletedNCT01198639

Hopital Foch2,044 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,044

Conditions

General Anesthesia

Interventions

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (22)

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

...and 12 more locations

Outcomes

Primary Outcomes

Mortality rate during the first year following anesthesia

Time frame: one year after anesthesia

Secondary Outcomes

conduct of anesthesia (duration of anesthesia with bispectral index < 45, bispectral index < 40, bispectral index > 60, bispectral index > 65, and burst suppression ratio)

Time frame: end of anesthesia

intraoperative awareness

Time frame: one month postoperatively

patients' satisfaction in the postanesthesia care unit (nausea, vomiting, shivering)

Time frame: end of the stay in the postanesthesia care unit

postoperative complication during the hospital stay (ancillary study)

Time frame: one month after anesthesia

major medical events during the first year following anesthesia

Time frame: one year after anesthesia

relation between patients' characteristics and mortality rate during the first year following anesthesia

Time frame: one year after anesthesia

intraoperative parameters, notably hemodynamic parameters, and their relation between them and mortality rate during the first year following anesthesia

Time frame: one year after anesthesia

in-hospital and one month mortality

Time frame: one year after anesthesia