Intraoperative EEG Marker of Preoperative Frailty in Elderly Patients

March 30, 2022 updated by: Pontificia Universidad Catolica de Chile

Study of an Intraoperative Frontal Electroencephalographic Marker of Preoperative Frailty in Patients Over 65 Years of Age for Elective Non-cardiac Surgery.

Frailty is a state of vulnerability, characterized by a loss of mechanisms that maintain homeostasis, determining a lower capacity for recovery in the event of a stressful incident. It is one of the risk factors that increase postoperative adverse outcomes in the elderly population. It has been associated with worse results in different surgical settings, including increased mortality, readmission, referral to specialized care units, increased costs and hospital stay. Currently, there are several instruments for diagnosis and screening of frailty. All of them require time for their execution, an experienced evaluator and an adequate validation in the population in which they are intended to be used. The use of frontal electroencephalography during the intraoperative period has become increasingly popular. It allows the monitoring of brain activity during the administration of anesthetics. Various intraoperative electroencephalographic markers, such as alpha spectral power or total spectrum power, have been associated with factors such as preoperative physical activity, preoperative cognitive level, comorbidities, and postoperative delirium. The objective of this study will be to determine an intraoperative frontal electroencephalographic marker of preoperative frailty in ≥ 65 years patients undergoing general anesthesia with Sevoflurane for non-cardiac surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The world health organization has estimated that the population over 60 years of age will increase exponentially between 2015 and 2050. This change will be more pronounced in developing countries, including Chile. Each year, the number of older people (≥ 65 years) undergoing surgical interventions raises. This is due to a sustained increase in life expectancy, demographic changes, and progress in surgical/anesthetic techniques that allow this population to undergo less invasive procedures. In addition, older patients have a higher risk of postoperative morbidity and mortality compared to younger people.

Frailty is one of the risk factors that increase adverse postoperative outcomes in the elderly population. It is defined as a state of vulnerability or lack of physiological reserve that is characterized by an inadequate resolution of homeostasis after a stressful event. Frailty determines that an event can generate changes in the postoperative state of dependence of these patients; causing a person who was independent prior to surgery to end up requiring assistance with their activities of daily living after it. Frailty has been associated with worse outcomes in different surgical settings, including increased mortality, readmission, referral to specialized care units, increased costs and hospital stay. In addition, preoperative frailty has also been associated with postoperative delirium.

Currently, there are several instruments for the diagnosis and screening of frailty that present good sensitivity and specificity. All of them require time for their execution, an experienced evaluator and adequate validation in the population in which they are intended to be used. Furthermore, with some instruments, specific elements may be required, for example the Handgrip dynamometer for the Fried phenotype. These conditions are not always easy to obtain in the local preoperative setting and the tools are not always adequately validated for non-English speaking populations. Moreover, there is uncertainty regarding which frailty instrument to choose among the dozens described in the literature, and there are time pressures that prevent the addition of more tests or evaluations in the preoperative clinic.

The use of frontal electroencephalography (EEG) during the intraoperative period has become increasingly popular. It is used to obtain a real-time record of brain electrical activity during administration of anesthetics. Interpreting the EEG in the time domain in real time in the operation room is challenging. Therefore, various processed EEG monitors (BIS®, SedLine®) currently clinically used, have incorporated the spectral analysis to their records. The spectrum presents the advantage to show the frequency decomposition of the EEG segment for all frequencies in a given range (usually <30 Hz) by plotting the frequency on the X axis and power on the Y axis. The accumulation of spectra over time is called spectrogram and can be presented graphically on the monitor, where the X-axis represents time, Y axis the decomposition of frequencies, and the Z bar represents the amplitude or power of the different waves. With increasing age there is a decrease in spectral power and alpha wave coherence (8-12 Hz). In addition, decreased alpha spectral power during anesthetic administration has been correlated with preoperative cognitive dysfunction. Recently, preoperative physical activity, the spectral power of the alpha wave and the entire spectral band have been associated with postoperative delirium in the cardio-surgical population. In addition, the spectral power of the alpha wave and broadband power (baseline noise) has been correlated with changes in age and patient comorbidities.

The objective of this study will be to determine an intraoperative frontal electroencephalographic marker of preoperative frailty in a population older than 65 years undergoing general anesthesia with sevoflurane for elective non-cardiac surgery. Our hypothesis is that frail patients (determined by the FRAIL, Clinical Frailty Scale and Fried scales) undergoing general anesthesia with sevofluorane for non-cardiac surgery have a lower alpha spectral power and lower entire spectral band power of the EEG compared to patients of similar age, who are robust, undergoing the same type of surgeries.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 8330024
        • Hospital Clínico Pontificia Universidad Católica de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients ≥ 65 years scheduled for elective non-cardiac surgery requiring general anesthesia.

Description

Inclusion Criteria:

  • Patients ≥ 65 years of age
  • Undergoing elective non-cardiac surgery requiring general anesthesia with Sevoflurane
  • American Society of Anesthesiologists Physical Status I to III

Exclusion Criteria:

  • Emergency surgery
  • Neurosurgical patients
  • History of alcohol
  • History of recreational psychoactive drug use
  • Allergy to anesthetic drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Robust
Patients ≥65 years, undergoing elective non cardiac surgery which Fried phenotype score is equal to 0
Device: Intraoperative frontal electroencephalogram
Intra operative frontal electroencephalogram registration with 1 age adjusted Minimum Anesthetic Concentration of Sevoflurane
Pre Frail
Patients ≥65 years, undergoing elective non cardiac surgery which Fried phenotype score is 1 or 2
Device: Intraoperative frontal electroencephalogram
Intra operative frontal electroencephalogram registration with 1 age adjusted Minimum Anesthetic Concentration of Sevoflurane
Frail
Patients ≥65 years, undergoing elective non cardiac surgery which Fried phenotype score is equal or greater than 3
Device: Intraoperative frontal electroencephalogram
Intra operative frontal electroencephalogram registration with 1 age adjusted Minimum Anesthetic Concentration of Sevoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroencephalogram Alpha power
Time Frame: 10 minutes after airway intubation
Frontal electroencephalogram spectral power between 8 - 12 Hz
10 minutes after airway intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroencephalogram Total power
Time Frame: 10 minutes after airway intubation
Frontal electroencephalogram spectral power between 0.1 - 35 Hz
10 minutes after airway intubation
Fried Phenotype
Time Frame: During preoperative anesthetic visit
Frailty assessed with the Fried Phenotype, minimum value: 1 - maximum value: 5, higher scores meaning worse outcomes.
During preoperative anesthetic visit
FRAIL scale
Time Frame: During preoperative anesthetic visit
Frailty assessed with the FRAIL Scale, minimum value: 1 - maximum value: 5, higher scores meaning worse outcomes.
During preoperative anesthetic visit
Clinical Frailty Scale (CFS)
Time Frame: During preoperative anesthetic visit
Frailty assessed with CFS, minimum value: 1(Very fit) - maximum value: 9 (Terminally ill), higher scores meaning worse outcomes.
During preoperative anesthetic visit
MiniCog test
Time Frame: During preoperative anesthetic visit
Screening for cognitive impairment, minimum value: 0 - maximum value: 5, higher scores meaning better outcomes
During preoperative anesthetic visit
MOCA (Montreal Cognitive Assessment) test
Time Frame: During preoperative anesthetic visit, if MiniCog is positive for cognitive impairment
Cognitive evaluation using MOCA (Montreal Cognitive Assessment) test, if MiniCog is positive for cognitive impairment (MiniCog ≤ 2). Minimum value: 0 - maximum value: 30, higher scores meaning better outcomes
During preoperative anesthetic visit, if MiniCog is positive for cognitive impairment
Post Anesthesia Care Unit (PACU) Postoperative Delirium
Time Frame: One hour after patient is admitted to PACU
Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), positive or negative
One hour after patient is admitted to PACU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2021

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 28, 2022

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200927001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

All data will be collected and saved in digital forms. Data may be shared with other researchers with previous authorization from the PI.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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