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Frail Status of Elderly Patients After Repair and Anesthesia Guided by the bispectraL Index (FRAGIL)

15. marts 2022 opdateret af: Hopital Foch

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

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.

Studieoversigt

Detaljeret beskrivelse

To date, patients over the age of 60 yrs represent 25% of the population and are at increased risk of surgical repair. Reduction of postoperative morbidity and mortality are now two main concerns for medical research. Dependence on caregivers and cognitive impairments are two major risks in the elderly and even more in frail patients after surgery under general anesthesia. In this context continuous monitoring of the depth of anesthesia through bispectral index may reduce its occurrence with better control of too deep sedation periods (vasopressors…). Previous studies by the investigators' team suggest a better duration in the expected interval of Bispectral Index with automated control of administration of intravenous anesthetics guided by Bispectral Index. This method remains to be tested in this high-risk population. As a consequence, a randomization into two groups will be carried on elderly patients (> 70 yrs): manual administration of anesthetics guided by Bispectral Index (manual group) or automated administration (automated group). Complete preoperative assessments will determine the FRAIL status (with a decrease in the physiological reserve) and abilities of the patient according to the self-sufficient scale. At six months a follow-up will determine the geriatric status of the patient to explore the rate of impairment and to examine predictive factors in the preoperative assessment. Finally, the influence of the method of administration will be reported. Four hundred and thirty patients will be included in this multicenter study with 215 patients per group and stratification of the presence of a cancer and of the abdominal repair. The follow-up in this study allows the patient or his/her relatives to keep in touch with a physician and to prescribe some therapy early if frailty or any other cognitive impairment appears.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

134

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Besançon, Frankrig, 25030
        • Hopital Jean Minjoz
      • Levallois-Perret, Frankrig, 92300
        • Institut Hopsitalier Franco-Britannique
      • Soyaux, Frankrig, 16800
        • Centre Clinical
      • Suresnes, Frankrig, 92150
        • Hopital Foch

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

70 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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:
  • controller
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
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
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. juli 2015

Primær færdiggørelse (Faktiske)

30. januar 2018

Studieafslutning (Faktiske)

30. januar 2018

Datoer for studieregistrering

Først indsendt

10. august 2015

Først indsendt, der opfyldte QC-kriterier

13. august 2015

Først opslået (Skøn)

14. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2014/28
  • 2014-A01270-47 (Anden identifikator: ANSM)

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Kliniske forsøg med Anæstesi, general

Kliniske forsøg med Toolbox: Automated group

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