Anesthesia, General Clinical Trial
— FRAGILOfficial title:
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
Verified date | March 2022 |
Source | Hopital Foch |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 134 |
Est. completion date | January 30, 2018 |
Est. primary completion date | January 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hopital Jean Minjoz | Besançon | |
France | Institut Hopsitalier Franco-Britannique | Levallois-Perret | |
France | Centre Clinical | Soyaux | |
France | Hopital Foch | Suresnes |
Lead Sponsor | Collaborator |
---|---|
Hopital Foch |
France,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of patients without occurrence of disability according to the InterRai scale | 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 | |
Secondary | Mortality at day 28 | 28 days | ||
Secondary | Mortality at month 6 | 6 months | ||
Secondary | Rate of postoperative cognitive dysfunction | Cognitive dysfunction is evaluated using the Mini Mental State examination | 6 months | |
Secondary | Incidence of pneumopathy | Defined as a septic syndrome (fever) + increased number of polynuclear cells + typical image on chest X-ray + treatment with antibiotics | 6 months | |
Secondary | Incidence of pulmonary embolism | Diagnosis on CT-scan with contrast injection | 6 months | |
Secondary | Incidence of postoperative myocardial infarction | EKG modification and raised troponin | 6 months | |
Secondary | Incidence of evolution of the frail phenotype | Frail phenotype accordingly to Fried Scale | 6 months | |
Secondary | Quality of the general anesthesia | Defined as the time with a Bispectral Index in the interval 40-60 | 1 day | |
Secondary | Performance of the automated system | Defined according to the Varvell score | 1 day | |
Secondary | Presence of Suppression Ratio | Defined as a period of isoelectric cortical signal with a threshold at 10% for 1 minute | 1 day | |
Secondary | Occurrence of arterial hypotension requiring treatment | 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 | |
Secondary | Patients'satisfaction about general anesthesia | Evaluation using a numeric scale from 0 (the worst remembrance) to 10 (an excellent moment) | 1 day | |
Secondary | Occurrence of awareness | Postoperative specific questionnaire | 3 months |
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