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One-year Mortality After Surgery and Low Bispectral Index

NCT01198639 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2044

Last updated 2018-02-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hopital Foch

    lead OTHER

Principal Investigators

  • Marc Fischler, MD · Hôpital Foch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-13
Primary Completion
2014-02-20
Completion
2015-02-20

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01198639 on ClinicalTrials.gov