Overview

This trial is active, not recruiting.

Condition general anesthesia
Treatments manual administration of iv anesthetics (propofol and remifentanil) using the toolbox platform, closed-loop administration of iv anesthetics (propofol and remifentanil) using the toolbox platform
Phase phase 4
Sponsor Hopital Foch
Start date September 2010
End date December 2016
Trial size 4200 participants
Trial identifier NCT01198639, 2009/30

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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
(Experimental)
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

Primary Outcomes

Measure
Mortality rate during the first year following anesthesia
time frame: one year after anesthesia

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 50 years up to 85 years old.

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

Additional Information

Official title One-year Mortality According to the Method of Total Intravenous Anesthesia. A Prospective, Randomized and Multicenter Study
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Hopital Foch.