NCT01198639

One-year Mortality After Surgery and Low Bispectral Index

One-year Mortality According to the Method of Total Intravenous Anesthesia. A Prospective, Randomized and Multicenter Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,044 (actual)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• General Anesthesia

Interventions

Type	Name	Description
DEVICE	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
DEVICE	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

Timeline

• Start date: 2010-09-13
• Primary completion: 2014-02-20
• Completion: 2015-02-20
• First posted: 2010-09-10
• Last updated: 2018-02-15

Locations

22 sites across 1 country: France