Frail Status of Elderly Patients After Repair and Anesthesia Guided by the bispectraL Index

Anesthesia, General Clinical Trial

— FRAGIL  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02524327
• Other study ID #: 2014/28
• Secondary ID: 2014-A01270-47
• Status: Terminated
• Phase: N/A
• Start date: July 7, 2015
• Est. completion date: January 30, 2018

Study information

• Verified date: March 2022
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aged, 70 and Over
• Anesthesia, General

Intervention

Other:
• Toolbox: Automated group
A dedicated algorithm controls the infusion rate of drugs depending on the magnitude of variation of the bispectral index
• Manual group
The anesthesiologist controls the infusion rate of drugs depending of the magnitude of variation of the bispectral index

Locations

Country	Name	City	State
France	Hopital Jean Minjoz	Besançon
France	Institut Hopsitalier Franco-Britannique	Levallois-Perret
France	Centre Clinical	Soyaux
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (2)

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

Outcome

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