General Anesthesia
Conditions
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.
Interventions
DEVICEmanual 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
DEVICEclosed-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
Sponsors
Hopital Foch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality rate during the first year following anesthesia | one year after anesthesia |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| in-hospital and one month mortality | one year after anesthesia |
| major medical events during the first year following anesthesia | one year after anesthesia |
Countries
France
Outcome results
None listed