- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Besançon, Frankrike, 25030
- Hopital Jean Minjoz
-
Levallois-Perret, Frankrike, 92300
- Institut Hopsitalier Franco-Britannique
-
Soyaux, Frankrike, 16800
- Centre Clinical
-
Suresnes, Frankrike, 92150
- Hopital Foch
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 navn:
|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Dødelighet på dag 28
Tidsramme: 28 dager
|
28 dager
|
|
|
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
|
6 months
|
|
Incidence of pneumopathy
Tidsramme: 6 months
|
Defined as a septic syndrome (fever) + increased number of polynuclear cells + typical image on chest X-ray + treatment with antibiotics
|
6 months
|
|
Incidence of pulmonary embolism
Tidsramme: 6 months
|
Diagnosis on CT-scan with contrast injection
|
6 months
|
|
Incidence of postoperative myocardial infarction
Tidsramme: 6 months
|
EKG modification and raised troponin
|
6 months
|
|
Incidence of evolution of the frail phenotype
Tidsramme: 6 months
|
Frail phenotype accordingly to Fried Scale
|
6 months
|
|
Quality of the general anesthesia
Tidsramme: 1 day
|
Defined as the time with a Bispectral Index in the interval 40-60
|
1 day
|
|
Performance of the automated system
Tidsramme: 1 day
|
Defined according to the Varvell score
|
1 day
|
|
Presence of Suppression Ratio
Tidsramme: 1 day
|
Defined as a period of isoelectric cortical signal with a threshold at 10% for 1 minute
|
1 day
|
|
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
|
Evaluation using a numeric scale from 0 (the worst remembrance) to 10 (an excellent moment)
|
1 day
|
|
Occurrence of awareness
Tidsramme: 3 months
|
Postoperative specific questionnaire
|
3 months
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2014/28
- 2014-A01270-47 (Annen identifikator: ANSM)
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