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Completed

NCT Number: NCT01198639

One-year Mortality After Surgery and Low Bispectral Index

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.

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Key information

Conditions

General Anesthesia

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Victor Dupuy, Argenteuil, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform

Device

the anesthesiologists are instructed to maintain the BIS values between 40 and 60 throughout anesthesia using target controlled infusion method

closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform

Device

an algorithm is used to maintain automatically the BIS values between 40 and 60

Primary outcomes

  1. Mortality rate during the first year following anesthesia

    Time frame: one year after anesthesia

Secondary outcomes

  1. 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

  2. intraoperative awareness

    Time frame: one month postoperatively

  3. patients' satisfaction in the postanesthesia care unit (nausea, vomiting, shivering)

    Time frame: end of the stay in the postanesthesia care unit

  4. postoperative complication during the hospital stay (ancillary study)

    Time frame: one month after anesthesia

  5. major medical events during the first year following anesthesia

    Time frame: one year after anesthesia

  6. relation between patients' characteristics and mortality rate during the first year following anesthesia

    Time frame: one year after anesthesia

  7. 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

  8. in-hospital and one month mortality

    Time frame: one year after anesthesia

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: ELA

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Sep 10, 2010
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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