ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01198639
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Brief 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.


Condition or disease Intervention/treatment Phase
General Anesthesia Device: manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform Device: closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2044 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: One-year Mortality According to the Method of Total Intravenous Anesthesia. A Prospective, Randomized and Multicenter Study
Actual Study Start Date : September 13, 2010
Actual Primary Completion Date : February 20, 2014
Actual Study Completion Date : February 20, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Mortality rate during the first year following anesthesia [ Time Frame: one year after anesthesia ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198639


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