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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robust | Patients ≥65 years, undergoing elective non cardiac surgery which Fried phenotype score is equal to 0 |
| |
| Pre Frail | Patients ≥65 years, undergoing elective non cardiac surgery which Fried phenotype score is 1 or 2 |
| |
| Frail | Patients ≥65 years, undergoing elective non cardiac surgery which Fried phenotype score is equal or greater than 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative frontal electroencephalogram | Device | Intra operative frontal electroencephalogram registration with 1 age adjusted Minimum Anesthetic Concentration of Sevoflurane |
| Measure | Description | Time Frame |
|---|---|---|
| Electroencephalogram Alpha power | Frontal electroencephalogram spectral power between 8 - 12 Hz | 10 minutes after airway intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Electroencephalogram Total power | Frontal electroencephalogram spectral power between 0.1 - 35 Hz | 10 minutes after airway intubation |
| Fried Phenotype | Frailty assessed with the Fried Phenotype, minimum value: 1 - maximum value: 5, higher scores meaning worse outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients ≥ 65 years scheduled for elective non-cardiac surgery requiring general anesthesia.
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| Name | Affiliation | Role |
|---|---|---|
| Juan C Pedemonte, MD | Pontificia Universidad Catolica de Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Pontificia Universidad Católica de Chile | Santiago | Santiago Metropolitan | 8330024 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26771471 | Background | Soreide K, Wijnhoven BP. Surgery for an ageing population. Br J Surg. 2016 Jan;103(2):e7-9. doi: 10.1002/bjs.10071. No abstract available. | |
| 31115918 | Background | Fowler AJ, Abbott TEF, Prowle J, Pearse RM. Age of patients undergoing surgery. Br J Surg. 2019 Jul;106(8):1012-1018. doi: 10.1002/bjs.11148. Epub 2019 May 22. |
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All data will be collected and saved in digital forms. Data may be shared with other researchers with previous authorization from the PI.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 14, 2021 | Mar 15, 2021 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 14, 2021 | Mar 15, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| During preoperative anesthetic visit |
| FRAIL scale | 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) | 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 | Screening for cognitive impairment, minimum value: 0 - maximum value: 5, higher scores meaning better outcomes | During preoperative anesthetic visit |
| MOCA (Montreal Cognitive Assessment) test | 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 | Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), positive or negative | One hour after patient is admitted to PACU |
| 32384342 | Background | Norris CM, Close JCT. Prehabilitation for the Frailty Syndrome: Improving Outcomes for Our Most Vulnerable Patients. Anesth Analg. 2020 Jun;130(6):1524-1533. doi: 10.1213/ANE.0000000000004785. |
| 24731176 | Background | Deiner S, Westlake B, Dutton RP. Patterns of surgical care and complications in elderly adults. J Am Geriatr Soc. 2014 May;62(5):829-35. doi: 10.1111/jgs.12794. Epub 2014 Apr 14. |
| 23395245 | Background | Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8. |
| 30509455 | Background | Panayi AC, Orkaby AR, Sakthivel D, Endo Y, Varon D, Roh D, Orgill DP, Neppl RL, Javedan H, Bhasin S, Sinha I. Impact of frailty on outcomes in surgical patients: A systematic review and meta-analysis. Am J Surg. 2019 Aug;218(2):393-400. doi: 10.1016/j.amjsurg.2018.11.020. Epub 2018 Nov 27. |
| 27096563 | Background | Brown CH 4th, Max L, LaFlam A, Kirk L, Gross A, Arora R, Neufeld K, Hogue CW, Walston J, Pustavoitau A. The Association Between Preoperative Frailty and Postoperative Delirium After Cardiac Surgery. Anesth Analg. 2016 Aug;123(2):430-5. doi: 10.1213/ANE.0000000000001271. |
| 32384341 | Background | Mahanna-Gabrielli E, Zhang K, Sieber FE, Lin HM, Liu X, Sewell M, Deiner SG, Boockvar KS. Frailty Is Associated With Postoperative Delirium But Not With Postoperative Cognitive Decline in Older Noncardiac Surgery Patients. Anesth Analg. 2020 Jun;130(6):1516-1523. doi: 10.1213/ANE.0000000000004773. |
| 29374358 | Background | Watt J, Tricco AC, Talbot-Hamon C, Pham B, Rios P, Grudniewicz A, Wong C, Sinclair D, Straus SE. Identifying Older Adults at Risk of Delirium Following Elective Surgery: A Systematic Review and Meta-Analysis. J Gen Intern Med. 2018 Apr;33(4):500-509. doi: 10.1007/s11606-017-4204-x. Epub 2018 Jan 26. |
| 31569165 | Background | McIsaac DI, Harris EP, Hladkowicz E, Moloo H, Lalu MM, Bryson GL, Huang A, Joanisse J, Hamilton GM, Forster AJ, van Walraven C. Prospective Comparison of Preoperative Predictive Performance Between 3 Leading Frailty Instruments. Anesth Analg. 2020 Jul;131(1):263-272. doi: 10.1213/ANE.0000000000004475. |
| 28866353 | Background | Gleason LJ, Benton EA, Alvarez-Nebreda ML, Weaver MJ, Harris MB, Javedan H. FRAIL Questionnaire Screening Tool and Short-Term Outcomes in Geriatric Fracture Patients. J Am Med Dir Assoc. 2017 Dec 1;18(12):1082-1086. doi: 10.1016/j.jamda.2017.07.005. Epub 2017 Aug 31. |
| 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. |
| 22836700 | Background | Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging. 2012 Jul;16(7):601-8. doi: 10.1007/s12603-012-0084-2. |
| 16129869 | Background | Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051. |
| 32128722 | Background | Darvall JN, Loth J, Bose T, Braat S, De Silva A, Story DA, Lim WK. Accuracy of the Clinical Frailty Scale for perioperative frailty screening: a prospective observational study. Can J Anaesth. 2020 Jun;67(6):694-705. doi: 10.1007/s12630-020-01610-x. Epub 2020 Mar 3. |
| 26275092 | Background | Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841. |
| 26174300 | Background | Purdon PL, Pavone KJ, Akeju O, Smith AC, Sampson AL, Lee J, Zhou DW, Solt K, Brown EN. The Ageing Brain: Age-dependent changes in the electroencephalogram during propofol and sevoflurane general anaesthesia. Br J Anaesth. 2015 Jul;115 Suppl 1(Suppl 1):i46-i57. doi: 10.1093/bja/aev213. |
| 28533746 | Background | Giattino CM, Gardner JE, Sbahi FM, Roberts KC, Cooter M, Moretti E, Browndyke JN, Mathew JP, Woldorff MG, Berger M; MADCO-PC Investigators. Intraoperative Frontal Alpha-Band Power Correlates with Preoperative Neurocognitive Function in Older Adults. Front Syst Neurosci. 2017 May 8;11:24. doi: 10.3389/fnsys.2017.00024. eCollection 2017. |
| 32349072 | Background | Pedemonte JC, Plummer GS, Chamadia S, Locascio JJ, Hahm E, Ethridge B, Gitlin J, Ibala R, Mekonnen J, Colon KM, Westover MB, D'Alessandro DA, Tolis G, Houle T, Shelton KT, Qu J, Akeju O. Electroencephalogram Burst-suppression during Cardiopulmonary Bypass in Elderly Patients Mediates Postoperative Delirium. Anesthesiology. 2020 Aug;133(2):280-292. doi: 10.1097/ALN.0000000000003328. |
| 32747077 | Background | Kaiser HA, Hirschi T, Sleigh C, Reineke D, Hartwich V, Stucki M, Rummel C, Sleigh J, Hight D. Comorbidity-dependent changes in alpha and broadband electroencephalogram power during general anaesthesia for cardiac surgery. Br J Anaesth. 2020 Oct;125(4):456-465. doi: 10.1016/j.bja.2020.06.054. Epub 2020 Jul 31. |
| 33079882 | Background | Evered LA, Vitug S, Scott DA, Silbert B. Preoperative Frailty Predicts Postoperative Neurocognitive Disorders After Total Hip Joint Replacement Surgery. Anesth Analg. 2020 Nov;131(5):1582-1588. doi: 10.1213/ANE.0000000000004893. |
| 36738630 | Derived | Boncompte G, Sun H, Elgueta MF, Benavides J, Carrasco M, Morales MI, Calderon N, Contreras V, Westover MB, Cortinez LI, Akeju O, Pedemonte JC. Intraoperative electroencephalographic marker of preoperative frailty: A prospective cohort study. J Clin Anesth. 2023 Jun;86:111069. doi: 10.1016/j.jclinane.2023.111069. Epub 2023 Feb 2. |