Clinical trial NCT02524327: Frail Status of Elderly Patients After Repair and Anesthesia Guided by the bispectraL Index
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anesthesia, General
Aged, 70 and Over
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 134
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of patients without occurrence of disability according to the InterRai scale
timeFrame: 6 months
Secondary outcomes:
measure: Mortality at day 28
timeFrame: 28 days
measure: Mortality at month 6
timeFrame: 6 months
measure: Rate of postoperative cognitive dysfunction
timeFrame: 6 months
measure: Incidence of pneumopathy
timeFrame: 6 months
measure: Incidence of pulmonary embolism
timeFrame: 6 months
measure: Incidence of postoperative myocardial infarction
timeFrame: 6 months
measure: Incidence of evolution of the frail phenotype
timeFrame: 6 months
measure: Quality of the general anesthesia
timeFrame: 1 day
measure: Performance of the automated system
timeFrame: 1 day
measure: Presence of Suppression Ratio
timeFrame: 1 day
measure: Occurrence of arterial hypotension requiring treatment
timeFrame: 1 day
measure: Patients'satisfaction about general anesthesia
timeFrame: 1 day
measure: Occurrence of awareness
timeFrame: 3 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Hopital Jean Minjoz
city: Levallois-Perret
country: France
facility: Institut Hopsitalier Franco-Britannique
city: Soyaux
country: France
facility: Centre Clinical
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Morgan Le Guen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.