Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01270-47 | Other Identifier | ANSM |
Not provided
Not provided
Material issues. Re-start in assessment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toolbox: Automated group | Experimental | 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 |
|
| Manual group | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toolbox: Automated group | Other | A dedicated algorithm controls the infusion rate of drugs depending on the magnitude of variation of the bispectral index |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at day 28 | 28 days | |
| Mortality at month 6 | 6 months | |
| Rate of postoperative cognitive dysfunction |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Morgan Le Guen, MD | Hopital Foch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Jean Minjoz | Besançon | 25030 | France | |||
| Institut Hopsitalier Franco-Britannique |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11253156 | Background | 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. | |
| 21233500 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C072262 | CDK13 protein, human |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Manual group | Other | The anesthesiologist controls the infusion rate of drugs depending of the magnitude of variation of the bispectral index |
|
Cognitive dysfunction is evaluated using the Mini Mental State examination |
| 6 months |
| 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 |
| Incidence of pulmonary embolism | Diagnosis on CT-scan with contrast injection | 6 months |
| Incidence of postoperative myocardial infarction | EKG modification and raised troponin | 6 months |
| Incidence of evolution of the frail phenotype | Frail phenotype accordingly to Fried Scale | 6 months |
| Quality of the general anesthesia | Defined as the time with a Bispectral Index in the interval 40-60 | 1 day |
| Performance of the automated system | Defined according to the Varvell score | 1 day |
| Presence of Suppression Ratio | Defined as a period of isoelectric cortical signal with a threshold at 10% for 1 minute | 1 day |
| 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 |
| Patients'satisfaction about general anesthesia | Evaluation using a numeric scale from 0 (the worst remembrance) to 10 (an excellent moment) | 1 day |
| Occurrence of awareness | Postoperative specific questionnaire | 3 months |
| Levallois-Perret |
| 92300 |
| France |
| Centre Clinical | Soyaux | 16800 | France |
| Hopital Foch | Suresnes | 92150 | France |
| 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. |
| 28298244 | Derived | 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. |