One-year Mortality After Surgery and Low Bispectral Index (ELA)

February 14, 2018 updated by: Hopital Foch

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2044

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argenteuil, France, 95107
        • CHU Victor Dupuy
      • Besançon, France, 25030
        • CHU Besançon
      • Bobigny, France, 93000
        • Hôpitaux Universitaires Paris-Seine St Denis CHU Avicenne
      • Bordeaux, France
        • Clinique Saint Augustin
      • Bourgoin-Jallieu, France
        • Clinique Saint Vincent de Paul
      • Bron, France
        • Hôpital Femme-Mère-Enfant
      • Chartres, France
        • CH de Chartres Louis Pasteur
      • Clamart, France
        • H.I.A Percy
      • Clermont-Ferrand, France
        • Centre Jean Perrin
      • Coquelles, France, 62231
        • Clinique des Deux Caps
      • Dijon, France, 21121
        • Clinique Fontaine-lès-Dijon
      • Grenoble, France, 38700
        • Chu de Grenoble
      • Levallois-Perret, France
        • Institut Hospitalier Franco Britannique
      • Marseille, France
        • Institut Paoli-Calmettes
      • Paris, France, 75005
        • Hia Du Val De Grace
      • Paris, France, 75908
        • HEGP
      • Poissy, France, 78303
        • CHI Poissy/St Germain-en-Laye
      • Rouen, France, 76000
        • CHU de Rouen
      • Saint-Mandé, France, 94163
        • HIA Begin
      • Suresnes, France, 92151
        • Hopital Foch
      • Toulouse, France, 31403
        • CHU Rangueil
      • Tours, France, 37044
        • Chu Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: manual administration of iv anesthetics
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
Experimental: closed-loop administration of iv anesthetics
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality rate during the first year following anesthesia
Time Frame: one year after anesthesia
one year after anesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
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
end of anesthesia
intraoperative awareness
Time Frame: one month postoperatively
one month postoperatively
patients' satisfaction in the postanesthesia care unit (nausea, vomiting, shivering)
Time Frame: end of the stay in the postanesthesia care unit
end of the stay in the postanesthesia care unit
postoperative complication during the hospital stay (ancillary study)
Time Frame: one month after anesthesia
one month after anesthesia
major medical events during the first year following anesthesia
Time Frame: one year after anesthesia
one year after anesthesia
relation between patients' characteristics and mortality rate during the first year following anesthesia
Time Frame: one year after anesthesia
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
one year after anesthesia
in-hospital and one month mortality
Time Frame: one year after anesthesia
one year after anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2010

Primary Completion (Actual)

February 20, 2014

Study Completion (Actual)

February 20, 2015

Study Registration Dates

First Submitted

September 9, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Actual)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/30

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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