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

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.

Study Overview

• Status: Terminated
• Conditions: Anesthesia, General; Aged, 70 and Over
• Intervention / Treatment: Other: Toolbox: Automated group; Other: Manual group

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.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • Hôpital Jean Minjoz
  • Levallois-Perret, France, 92300
    • Institut Hopsitalier Franco-Britannique
  • Soyaux, France, 16800
    • Centre Clinical
  • Suresnes, France, 92150
    • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Toolbox: Automated group; A dedicated algorithm controls the infusion rate of drugs depending on the magnitude of variation of the bispectral index; Other Names: controller
Active Comparator: 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	Other: Manual group; The anesthesiologist controls the infusion rate of drugs depending of the magnitude of variation of the bispectral index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality at day 28		28 days
Mortality at month 6		6 months
Rate of postoperative cognitive dysfunction	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

Collaborators and Investigators

• Sponsor: Hopital Foch

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2015
• Primary Completion (Actual): January 30, 2018
• Study Completion (Actual): January 30, 2018

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimate): August 14, 2015

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2014/28; 2014-A01270-47 (Other Identifier: ANSM)