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One-year Mortality After Surgery and Low Bispectral Index

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01198639
First received: September 9, 2010
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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 Intervention 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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: One-year Mortality According to the Method of Total Intravenous Anesthesia. A Prospective, Randomized and Multicenter Study

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Mortality rate during the first year following anesthesia [ Time Frame: one year after anesthesia ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • intraoperative awareness [ Time Frame: one month postoperatively ] [ Designated as safety issue: No ]
  • patients' satisfaction in the postanesthesia care unit (nausea, vomiting, shivering) [ Time Frame: end of the stay in the postanesthesia care unit ] [ Designated as safety issue: No ]
  • postoperative complication during the hospital stay (ancillary study) [ Time Frame: one month after anesthesia ] [ Designated as safety issue: No ]
  • major medical events during the first year following anesthesia [ Time Frame: one year after anesthesia ] [ Designated as safety issue: Yes ]
  • relation between patients' characteristics and mortality rate during the first year following anesthesia [ Time Frame: one year after anesthesia ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • in-hospital and one month mortality [ Time Frame: one year after anesthesia ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4200
Study Start Date: September 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198639

Contacts
Contact: Marc Fischler, MD 46252442 ext 00331 m.fischler@hopital-foch.org

Locations
France
CHU Besançon Recruiting
Besançon, France, 25030
Contact: Nathalie Boichut,, MD    81 66 85 79 ext +33 3    nboichut@chu-besancon.fr   
Hôpital Foch Recruiting
Suresnes, France, 92151
Contact: Thierry Chazot, MD    46252767 ext 00331    t.chazot@hopital-foch.org   
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hôpital Foch
  More Information

Publications:
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01198639     History of Changes
Other Study ID Numbers: 2009/30
Study First Received: September 9, 2010
Last Updated: January 7, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Anesthetics
Propofol
Remifentanil
Analgesics
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014