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

15. mars 2022 oppdatert av: 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.

Studieoversikt

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

134

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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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

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

70 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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:
  • 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

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

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Sponsor

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. juli 2015

Primær fullføring (Faktiske)

30. januar 2018

Studiet fullført (Faktiske)

30. januar 2018

Datoer for studieregistrering

Først innsendt

10. august 2015

Først innsendt som oppfylte QC-kriteriene

13. august 2015

Først lagt ut (Anslag)

14. august 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. mars 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. mars 2022

Sist bekreftet

1. mars 2022

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

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

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