- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Besançon, Frankrike, 25030
- Hôpital Jean Minjoz
-
Levallois-Perret, Frankrike, 92300
- Institut Hopsitalier Franco-Britannique
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Soyaux, Frankrike, 16800
- Centre Clinical
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Suresnes, Frankrike, 92150
- Hôpital Foch
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
|
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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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rate of patients without occurrence of disability according to the InterRai scale
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Dödlighet dag 28
Tidsram: 28 dagar
|
28 dagar
|
|
|
Mortality at month 6
Tidsram: 6 months
|
6 months
|
|
|
Rate of postoperative cognitive dysfunction
Tidsram: 6 months
|
Cognitive dysfunction is evaluated using the Mini Mental State examination
|
6 months
|
|
Incidence of pneumopathy
Tidsram: 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
Tidsram: 6 months
|
Diagnosis on CT-scan with contrast injection
|
6 months
|
|
Incidence of postoperative myocardial infarction
Tidsram: 6 months
|
EKG modification and raised troponin
|
6 months
|
|
Incidence of evolution of the frail phenotype
Tidsram: 6 months
|
Frail phenotype accordingly to Fried Scale
|
6 months
|
|
Quality of the general anesthesia
Tidsram: 1 day
|
Defined as the time with a Bispectral Index in the interval 40-60
|
1 day
|
|
Performance of the automated system
Tidsram: 1 day
|
Defined according to the Varvell score
|
1 day
|
|
Presence of Suppression Ratio
Tidsram: 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
Tidsram: 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
Tidsram: 1 day
|
Evaluation using a numeric scale from 0 (the worst remembrance) to 10 (an excellent moment)
|
1 day
|
|
Occurrence of awareness
Tidsram: 3 months
|
Postoperative specific questionnaire
|
3 months
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2014/28
- 2014-A01270-47 (Annan identifierare: ANSM)
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