Intraoperative EEG Marker of Preoperative Frailty in Elderly Patients

NCT04783662 | Completed

• 1 other identifier: 200927001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frailty

Keywords

Frailty; Electroencephalography; Pre operative; Alpha power

Outcome Measures

Primary Outcomes (1)

• Electroencephalogram Alpha power

  Frontal electroencephalogram spectral power between 8 - 12 Hz

  10 minutes after airway intubation

Secondary Outcomes (7)

• Electroencephalogram Total power

  10 minutes after airway intubation

• Fried Phenotype

  During preoperative anesthetic visit

• FRAIL scale

  During preoperative anesthetic visit

• Clinical Frailty Scale (CFS)

  During preoperative anesthetic visit

• MiniCog test

  During preoperative anesthetic visit

Study Arms (3)

Robust

Patients ≥65 years, undergoing elective non cardiac surgery which Fried phenotype score is equal to 0

Device: Intraoperative frontal electroencephalogram

Pre Frail

Patients ≥65 years, undergoing elective non cardiac surgery which Fried phenotype score is 1 or 2

Device: Intraoperative frontal electroencephalogram

Frail

Patients ≥65 years, undergoing elective non cardiac surgery which Fried phenotype score is equal or greater than 3

Device: Intraoperative frontal electroencephalogram

Interventions

Intraoperative frontal electroencephalogram DEVICE

Intra operative frontal electroencephalogram registration with 1 age adjusted Minimum Anesthetic Concentration of Sevoflurane

Frail; Pre Frail; Robust

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital Clínico Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, 8330024, Chile

Location

Related Publications (22)

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  PMID: 26771471 BACKGROUND

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  PMID: 31115918 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.

  PMID: 32384342 BACKGROUND

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  PMID: 23395245 BACKGROUND

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  PMID: 30509455 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.

  PMID: 27096563 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.

  PMID: 32384341 BACKGROUND

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  PMID: 29374358 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.

  PMID: 31569165 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.

  PMID: 28866353 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.

  PMID: 11253156 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.

  PMID: 22836700 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.

  PMID: 16129869 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.

  PMID: 32128722 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.

  PMID: 26275092 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.

  PMID: 26174300 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.

  PMID: 28533746 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.

  PMID: 32349072 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.

  PMID: 32747077 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.

  PMID: 33079882 BACKGROUND

• 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.

  PMID: 36738630 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan C Pedemonte, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: May 13, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 28, 2022
• Last Updated: March 31, 2022

Record last verified: 2021-01

Locations

CL (1)