Material issues. Re-start in assessment
FRAGIL
Influence of the Modality of General Anesthesia Guided by the Bispectral Index (Manual or Automated) on the Occurrence of a Loss of Capability in Elderly Patients (> 70 Yrs): a Randomized Multicenter Study
Sponsor study identifier
Secondary identifiers
OTHER · ANSM
interventional
134
1 country
4
Study Start
July 7, 2015
Actual (reported)Primary Completion
January 30, 2018
Actual (reported)Study Completion
January 30, 2018
Actual (reported)The first aim of this study is to compare two methods of administration of intravenous anesthetics to obtain the same level of depth (bispectral index between 40 and 60): manual or automated and to determine a mid-term (6 months) influence of the frail phenotype on self-sufficient elderly patients after general anesthesia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 7, 2015
Actual (reported)August 10, 2015
Actual (reported)August 14, 2015
Actual (reported)January 30, 2018
Actual (reported)January 30, 2018
Actual (reported)Rate of patients without occurrence of disability according to the InterRai scale
Disability is evaluated using the InterRai scale; a death is considered as an irreversible disability institutionalization is considered as a severe disability InterRai scale would discriminate other patients
6 months
Mortality at day 28
28 days
Mortality at month 6
6 months
Rate of postoperative cognitive dysfunction
6 months
Incidence of pneumopathy
6 months
Incidence of pulmonary embolism
6 months
Toolbox: Automated administration of intravenous anesthetic (propofol 1%) and analgesic (remifentanil, Ultiva(r)) guided by the Bispectral index through a controller with a previously described algorithm. Objective of depth anesthesia: 40-60
Manual administration of intravenous anesthetic (propofol 1%) and analgesic (remifentanil, Ultiva(r)) guided by the Bispectral index as usually performed in the operative theater. Objective of depth anesthesia: 40-60
A dedicated algorithm controls the infusion rate of drugs depending on the magnitude of variation of the bispectral index
The anesthesiologist controls the infusion rate of drugs depending of the magnitude of variation of the bispectral index
Hopital Jean Minjoz
Besançon, 25030, France
Institut Hopsitalier Franco-Britannique
Levallois-Perret, 92300, France
Centre Clinical
Soyaux, 16800, France
Hopital Foch
Suresnes, 92150, France
Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.
Morgan Le Guen, MD
Hopital Foch
134 participants (actual enrollment reported by the registry).
First Submitted
August 10, 2015
First Posted
August 14, 2015
Study Start
July 7, 2015
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Le Guen M, Herr M, Bizard A, Bichon C, Boichut N, Chazot T, Liu N, Ankri J, Fischler M. Frailty Related to Anesthesia guided by the Index "bispectraL" (FRAIL) study: study protocol for a randomized controlled trial. Trials. 2017 Mar 16;18(1):127. doi: 10.1186/s13063-017-1868-9.
Primary Completion
January 30, 2018
Actual (reported)Study Completion
January 30, 2018
Actual (reported)Last Updated
March 16, 2022
Record last verified: 2022-03
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Source: ClinicalTrials.gov.
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