- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02524327
Frail Status of Elderly Patients After Repair and Anesthesia Guided by the bispectraL Index (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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Besançon, Frankrig, 25030
- Hopital Jean Minjoz
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Levallois-Perret, Frankrig, 92300
- Institut Hopsitalier Franco-Britannique
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Soyaux, Frankrig, 16800
- Centre Clinical
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Suresnes, Frankrig, 92150
- Hopital Foch
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adult patients aged > 70 years old
- American Society of Anesthesiologists class I to III
- Scheduled for abdominal surgery under total intra-venous anesthesia
- Self sufficient (living at home or in a non medical institution)
- Written consent to the study
Exclusion Criteria:
- Allergy to any intravenous agent (propofol or remifentanil)
- Cognitive impairment with a Mini Mental State Examination < 20
- Severe visual or hearing deficiency, apraxia
- Restriction of the use of bispectral index
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Toolbox: Automated group
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 |
A dedicated algorithm controls the infusion rate of drugs depending on the magnitude of variation of the bispectral index
Andre navne:
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Aktiv komparator: Manual group
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 |
The anesthesiologist controls the infusion rate of drugs depending of the magnitude of variation of the bispectral index
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of patients without occurrence of disability according to the InterRai scale
Tidsramme: 6 months
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dødelighed på dag 28
Tidsramme: 28 dage
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28 dage
|
|
|
Mortality at month 6
Tidsramme: 6 months
|
6 months
|
|
|
Rate of postoperative cognitive dysfunction
Tidsramme: 6 months
|
Cognitive dysfunction is evaluated using the Mini Mental State examination
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6 months
|
|
Incidence of pneumopathy
Tidsramme: 6 months
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Defined as a septic syndrome (fever) + increased number of polynuclear cells + typical image on chest X-ray + treatment with antibiotics
|
6 months
|
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Incidence of pulmonary embolism
Tidsramme: 6 months
|
Diagnosis on CT-scan with contrast injection
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6 months
|
|
Incidence of postoperative myocardial infarction
Tidsramme: 6 months
|
EKG modification and raised troponin
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6 months
|
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Incidence of evolution of the frail phenotype
Tidsramme: 6 months
|
Frail phenotype accordingly to Fried Scale
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6 months
|
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Quality of the general anesthesia
Tidsramme: 1 day
|
Defined as the time with a Bispectral Index in the interval 40-60
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1 day
|
|
Performance of the automated system
Tidsramme: 1 day
|
Defined according to the Varvell score
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1 day
|
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Presence of Suppression Ratio
Tidsramme: 1 day
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Defined as a period of isoelectric cortical signal with a threshold at 10% for 1 minute
|
1 day
|
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Occurrence of arterial hypotension requiring treatment
Tidsramme: 1 day
|
Defined as a drop of 20% or more of the mean arterial pressure compared to the basal value measured before anesthetic induction and the requirement for a vasoactive agent
|
1 day
|
|
Patients'satisfaction about general anesthesia
Tidsramme: 1 day
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Evaluation using a numeric scale from 0 (the worst remembrance) to 10 (an excellent moment)
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1 day
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Occurrence of awareness
Tidsramme: 3 months
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Postoperative specific questionnaire
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3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2014/28
- 2014-A01270-47 (Anden identifikator: ANSM)
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