Status:
COMPLETED
One-year Mortality After Surgery and Low Bispectral Index
Lead Sponsor:
Hopital Foch
Conditions:
General Anesthesia
Eligibility:
All Genders
50-85 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 13 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2015
Estimated Enrollment :
2044 Patients enrolled
Trial Details
Trial ID
NCT01198639
Start Date
September 13 2010
End Date
February 20 2015
Last Update
February 15 2018
Active Locations (22)
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1
CHU Victor Dupuy
Argenteuil, France, 95107
2
CHU Besançon
Besançon, France, 25030
3
Hôpitaux Universitaires Paris-Seine St Denis CHU Avicenne
Bobigny, France, 93000
4
Clinique Saint Augustin
Bordeaux, France