At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
One-year Mortality According to the Method of Total Intravenous Anesthesia. A Prospective, Randomized and Multicenter Study
In Brief
A clinical study evaluating manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform and closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform for General Anesthesia. Completed, enrolled 2,044 participants across 22 sites.
Detailed 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.
Study Details
Timeline
Interventions
the anesthesiologists are instructed to maintain the BIS values between 40 and 60 throughout anesthesia using target controlled infusion method
an algorithm is used to maintain automatically the BIS values between 40 and 60