Protocol for the electroencephalography guidance of anesthesia to alleviate geriatric syndromes (ENGAGES-Canada) study: A pragmatic, randomized clinical trial

Alain Deschamps, Tarit Saha, Renée El-Gabalawy, Eric Jacobsohn, Charles Overbeek, Jennifer Palermo, Sophie Robichaud, Andrea Alicia Dumont, George Djaiani, Jo Carroll, Morvarid S Kavosh, Rob Tanzola, Eva M Schmitt, Sharon K Inouye, Jordan Oberhaus, Angela Mickle, Arbi Ben Abdallah, Michael S Avidan, Canadian Perioperative Anesthesia Clinical Trials Group, Alain Deschamps, Tarit Saha, Renée El-Gabalawy, Eric Jacobsohn, Charles Overbeek, Jennifer Palermo, Sophie Robichaud, Andrea Alicia Dumont, George Djaiani, Jo Carroll, Morvarid S Kavosh, Rob Tanzola, Eva M Schmitt, Sharon K Inouye, Jordan Oberhaus, Angela Mickle, Arbi Ben Abdallah, Michael S Avidan, Canadian Perioperative Anesthesia Clinical Trials Group

Abstract

Background: There is some evidence that electroencephalography guidance of general anesthesia can decrease postoperative delirium after non-cardiac surgery. There is limited evidence in this regard for cardiac surgery. A suppressed electroencephalogram pattern, occurring with deep anesthesia, is associated with increased incidence of postoperative delirium (POD) and death. However, it is not yet clear whether this electroencephalographic pattern reflects an underlying vulnerability associated with increased incidence of delirium and mortality, or whether it is a modifiable risk factor for these adverse outcomes. Methods: The Electroe ncephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes ( ENGAGES-Canada) is an ongoing pragmatic 1200 patient trial at four Canadian sites. The study compares the effect of two anesthetic management approaches on the incidence of POD after cardiac surgery. One approach is based on current standard anesthetic practice and the other on electroencephalography guidance to reduce POD. In the guided arm, clinicians are encouraged to decrease anesthetic administration, primarily if there is electroencephalogram suppression and secondarily if the EEG index is lower than the manufacturers recommended value (bispectral index (BIS) or WAVcns below 40 or Patient State Index below 25). The aim in the guided group is to administer the minimum concentration of anesthetic considered safe for individual patients. The primary outcome of the study is the incidence of POD, detected using the confusion assessment method or the confusion assessment method for the intensive care unit; coupled with structured delirium chart review. Secondary outcomes include unexpected intraoperative movement, awareness, length of intensive care unit and hospital stay, delirium severity and duration, quality of life, falls, and predictors and outcomes of perioperative distress and dissociation. Discussion: The ENGAGES-Canada trial will help to clarify whether or not using the electroencephalogram to guide anesthetic administration during cardiac surgery decreases the incidence, severity, and duration of POD. Registration: ClinicalTrials.gov ( NCT02692300) 26/02/2016.

Keywords: EEG suppression; anesthetic management; cardiac surgery; cardiopulmonary bypass; geriatric outcomes; perioperative risk factors; postoperative delirium; volatile anesthetics.

Conflict of interest statement

No competing interests were disclosed.

Copyright: © 2023 Deschamps A et al.

References

    1. Inouye SK, Westendorp RG, Saczynski JS: Delirium in elderly people. Lancet. 2014;383(9920):911–22. 10.1016/S0140-6736(13)60688-1
    1. Avidan MS, Maybrier HR, Abdallah AB, et al. : Intraoperative ketamine for prevention of postoperative delirium or pain after major surgery in older adults: an international, multicentre, double-blind, randomised clinical trial. Lancet. 2017;390(10091):267–75. 10.1016/S0140-6736(17)31467-8
    1. Fritz BA, Kalarickal PL, Maybrier HR, et al. : Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016;122(1):234–42. 10.1213/ANE.0000000000000989
    1. Djaiani G, Silverton N, Fedorko L, et al. : Dexmedetomidine versus Propofol Sedation Reduces Delirium after Cardiac Surgery: A Randomized Controlled Trial. Anesthesiology. 2016;124(2):362–8. 10.1097/ALN.0000000000000951
    1. Rudolph JL, Jones RN, Levkoff SE, et al. : Derivation and validation of a preoperative prediction rule for delirium after cardiac surgery. Circulation. 2009;119(2):229–36. 10.1161/CIRCULATIONAHA.108.795260
    1. Saczynski JS, Marcantonio ER, Quach L, et al. : Cognitive trajectories after postoperative delirium. N Engl J Med. 2012;367(1):30–9. 10.1056/NEJMoa1112923
    1. Whitlock EL, Torres BA, Lin N, et al. : Postoperative delirium in a substudy of cardiothoracic surgical patients in the BAG-RECALL clinical trial. Anesth Analg. 2014;118(4):809–17. 10.1213/ANE.0000000000000028
    1. Kotfis K, Szylińska A, Listewnik M, et al. : Early delirium after cardiac surgery: an analysis of incidence and risk factors in elderly (≥65 years) and very elderly (≥80 years) patients. Clin Interv Aging. 2018;13:1061–70. 10.2147/CIA.S166909
    1. Cereghetti C, Siegemund M, Schaedelin S, et al. : Independent Predictors of the Duration and Overall Burden of Postoperative Delirium After Cardiac Surgery in Adults: An Observational Cohort Study. J Cardiothorac Vasc Anesth. 2017;31(6):1966–73. 10.1053/j.jvca.2017.03.042
    1. Rudolph JL, Inouye SK, Jones RN, et al. : Delirium: an independent predictor of functional decline after cardiac surgery. J Am Geriatr Soc. 2010;58(4):643–9. 10.1111/j.1532-5415.2010.02762.x
    1. Sanders RD, Pandharipande PP, Davidson AJ, et al. : Anticipating and managing postoperative delirium and cognitive decline in adults. BMJ. 2011;343:d4331. 10.1136/bmj.d4331
    1. Kazmierski J, Kowman M, Banach M, et al. : Incidence and predictors of delirium after cardiac surgery: Results from The IPDACS Study. J Psychosom Res. 2010;69(2):179–85. 10.1016/j.jpsychores.2010.02.009
    1. Tully PJ, Baker RA, Winefield HR, et al. : Depression, anxiety disorders and Type D personality as risk factors for delirium after cardiac surgery. Aust N Z J Psychiatry. 2010;44(11):1005–11.
    1. Avidan MS, Jacobsohn E, Glick D, et al. : Prevention of intraoperative awareness in a high-risk surgical population. N Engl J Med. 2011;365(7):591–600. 10.1056/NEJMoa1100403
    1. Avidan MS, Zhang L, Burnside BA, et al. : Anesthesia awareness and the bispectral index. N Engl J Med. 2008;358(11):1097–108. 10.1056/NEJMoa0707361
    1. Avidan MS, Mashour GA: Prevention of intraoperative awareness with explicit recall: making sense of the evidence. Anesthesiology. 2013;118(2):449–56. 10.1097/ALN.0b013e31827ddd2c
    1. Aldecoa C, Bettelli G, Bilotta F, et al. : European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017;34(4):192–214. 10.1097/EJA.0000000000000594
    1. American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults: American Geriatrics Society abstracted clinical practice guideline for postoperative delirium in older adults. J Am Geriatr Soc. 2015;63(1):142–50. 10.1111/jgs.13281
    1. Brown EN, Lydic R, Schiff ND: General anesthesia, sleep, and coma. N Engl J Med. 2010;363(27):2638–50. 10.1056/NEJMra0808281
    1. Hagihira S: Changes in the electroencephalogram during anaesthesia and their physiological basis. Br J Anaesth. 2015;115 Suppl 1:i27–i31. 10.1093/bja/aev212
    1. Fritz BA, Maybrier HR, Avidan MS: Intraoperative electroencephalogram suppression at lower volatile anaesthetic concentrations predicts postoperative delirium occurring in the intensive care unit. Br J Anaesth. 2018;121(1):241–248. 10.1016/j.bja.2017.10.024
    1. Soehle M, Dittmann A, Ellerkmann RK, et al. : Intraoperative burst suppression is associated with postoperative delirium following cardiac surgery: a prospective, observational study. BMC Anesthesiol. 2015;15:61. 10.1186/s12871-015-0051-7
    1. Willingham M, Ben Abdallah A, Gradwohl S, et al. : Association between intraoperative electroencephalographic suppression and postoperative mortality. Br J Anaesth. 2014;113(6):1001–8. 10.1093/bja/aeu105
    1. Punjasawadwong Y, Chau-In W, Laopaiboon M, et al. : Processed electroencephalogram and evoked potential techniques for amelioration of postoperative delirium and cognitive dysfunction following non-cardiac and non-neurosurgical procedures in adults. Cochrane Database Syst Rev. 2018;5(5):CD011283. 10.1002/14651858.CD011283.pub2
    1. MacKenzie KK, Britt-Spells AM, Sands LP, et al. : Processed Electroencephalogram Monitoring and Postoperative Delirium: A Systematic Review and Meta-analysis. Anesthesiology. 2018;129(3):417–27. 10.1097/ALN.0000000000002323
    1. Wildes TS, Mickle AM, Ben Abdallah A, et al. : Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019;321(5):473–83. 10.1001/jama.2018.22005
    1. Wildes TS, Winter AC, Maybrier HR, et al. : Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) study: a pragmatic, randomised clinical trial. BMJ Open. 2016;6(6):e011505. 10.1136/bmjopen-2016-011505
    1. Mickle AM, Maybrier HR, Winter AC, et al. : Achieving Milestones as a Prerequisite for Proceeding With a Clinical Trial. Anesth Analg. 2018;126(6):1851–8. 10.1213/ANE.0000000000002680
    1. Chan AW, Tetzlaff JM, Altman DG, et al. : SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Chan AW, Tetzlaff JM, Gøtzsche PC, et al. : SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. 10.1136/bmj.e7586
    1. Aranake A, Gradwohl S, Ben-Abdallah A, et al. : Increased risk of intraoperative awareness in patients with a history of awareness. Anesthesiology. 2013;119(6):1275–83. 10.1097/ALN.0000000000000023
    1. Deschamps A: ENGAGES-Canada. 2019. 10.17605/
    1. Morimoto Y, Hagihira S, Koizumi Y, et al. : The relationship between bispectral index and electroencephalographic parameters during isoflurane anesthesia. Anesth Analg. 2004;98(5):1336–40, table of contents. 10.1213/01.ane.0000105867.17108.b6
    1. Bottros MM, Palanca BJ, Mashour GA, et al. : Estimation of the bispectral index by anesthesiologists: an inverse turing test. Anesthesiology. 2011;114(5):1093–101. 10.1097/ALN.0b013e31820e7c5c
    1. Weintraub S, Dikmen SS, Heaton RK, et al. : The cognition battery of the NIH toolbox for assessment of neurological and behavioral function: validation in an adult sample. J Int Neuropsychol Soc. 2014;20(6):567–78. 10.1017/S1355617714000320
    1. Heaton RK, Akshoomoff N, Tulsky D, et al. : Reliability and validity of composite scores from the NIH Toolbox Cognition Battery in adults. J Int Neuropsychol Soc. 2014;20(6):588–98. 10.1017/S1355617714000241
    1. Rudolph JL, Jones RN, Grande LJ, et al. : Impaired executive function is associated with delirium after coronary artery bypass graft surgery. J Am Geriatr Soc. 2006;54(6):937–41. 10.1111/j.1532-5415.2006.00735.x
    1. Galvin JE, Roe CM, Powlishta KK, et al. : The AD8: a brief informant interview to detect dementia. Neurology. 2005;65(4):559–64. 10.1212/01.wnl.0000172958.95282.2a
    1. Davis PB, Morris JC, Grant E: Brief screening tests versus clinical staging in senile dementia of the Alzheimer type. J Am Geriatr Soc. 1990;38(2):129–35. 10.1111/j.1532-5415.1990.tb03473.x
    1. Harris PA, Taylor R, Thielke R, et al. : Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81. 10.1016/j.jbi.2008.08.010
    1. Whitlock EL, Villafranca AJ, Lin N, et al. : Relationship between bispectral index values and volatile anesthetic concentrations during the maintenance phase of anesthesia in the B-Unaware trial. Anesthesiology. 2011;115(6):1209–18. 10.1097/ALN.0b013e3182395dcb
    1. Inouye SK, van Dyck CH, Alessi CA, et al. : Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990;113(12):941–8. 10.7326/0003-4819-113-12-941
    1. Ely EW, Inouye SK, Bernard GR, et al. : Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001;286(21):2703–10. 10.1001/jama.286.21.2703
    1. Ely EW, Margolin R, Francis J, et al. : Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001;29(7):1370–9. 10.1097/00003246-200107000-00012
    1. Wei LA, Fearing MA, Sternberg EJ, et al. : The Confusion Assessment Method: a systematic review of current usage. J Am Geriatr Soc. 2008;56(5):823–30. 10.1111/j.1532-5415.2008.01674.x
    1. Luetz A, Heymann A, Radtke FM, et al. : Different assessment tools for intensive care unit delirium: which score to use? Crit Care Med. 2010;38(2):409–18. 10.1097/CCM.0b013e3181cabb42
    1. Plaschke K, von Haken R, Scholz M, et al. : Comparison of the confusion assessment method for the intensive care unit (CAM-ICU) with the Intensive Care Delirium Screening Checklist (ICDSC) for delirium in critical care patients gives high agreement rate(s). Intensive Care Med. 2008;34(3):431–6. 10.1007/s00134-007-0920-8
    1. Inouye SK, Leo-Summers L, Zhang Y, et al. : A chart-based method for identification of delirium: validation compared with interviewer ratings using the confusion assessment method. J Am Geriatr Soc. 2005;53(2):312–8. 10.1111/j.1532-5415.2005.53120.x
    1. Saczynski JS, Kosar CM, Xu G, et al. : A tale of two methods: chart and interview methods for identifying delirium. J Am Geriatr Soc. 2014;62(3):518–24. 10.1111/jgs.12684
    1. Inouye SK, Kosar CM, Tommet D, et al. : The CAM-S: development and validation of a new scoring system for delirium severity in 2 cohorts. Ann Intern Med. 2014;160(8):526–33. 10.7326/M13-1927
    1. Khan BA, Perkins AJ, Gao S, et al. : The Confusion Assessment Method for the ICU-7 Delirium Severity Scale: A Novel Delirium Severity Instrument for Use in the ICU. Crit Care Med. 2017;45(5):851–7. 10.1097/CCM.0000000000002368
    1. Ramaswamy R, Dix EF, Drew JE, et al. : Beyond grand rounds: a comprehensive and sequential intervention to improve identification of delirium. Gerontologist. 2011;51(1):122–31. 10.1093/geront/gnq075
    1. Newcombe RG: Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med. 1998;17(8):873–90. 10.1002/(SICI)1097-0258(19980430)17:8<873::AID-SIM779>;2-I
    1. Steingrimsson JA, Hanley DF, Rosenblum M: Improving precision by adjusting for prognostic baseline variables in randomized trials with binary outcomes, without regression model assumptions. Contemp Clin Trials. 2017;54:18–24. 10.1016/j.cct.2016.12.026
    1. Sieber FE, Neufeld KJ, Gottschalk A, et al. : Effect of Depth of Sedation in Older Patients Undergoing Hip Fracture Repair on Postoperative Delirium: The STRIDE Randomized Clinical Trial. JAMA Surg. 2018;153(11):987–995. 10.1001/jamasurg.2018.2602
    1. Johnson VE: Revised standards for statistical evidence. Proc Natl Acad Sci U S A. 2013;110(48):19313–7. 10.1073/pnas.1313476110
    1. van Velthuijsen EL, Zwakhalen SM, Warnier RM, et al. : Psychometric properties and feasibility of instruments for the detection of delirium in older hospitalized patients: a systematic review. Int J Geriatr Psychiatry. 2016;31(9):974–89. 10.1002/gps.4441
    1. Adamis D, Sharma N, Whelan PJ, et al. : Delirium scales: A review of current evidence. Aging Ment Health. 2010;14(5):543–55. 10.1080/13607860903421011
    1. Maybrier HR, Mickle AM, Escallier KE, et al. : Reliability and accuracy of delirium assessments among investigators at multiple international centres. BMJ Open. 2018;8(11):e023137. 10.1136/bmjopen-2018-023137
    1. Hall R, Beattie S, Cheng D, et al. : Can we develop a Canadian Perioperative Anesthesiology Clinical Trials group? Can J Anaesth. 2010;57(12):1051–7. 10.1007/s12630-010-9385-2
    1. Deschamps A, Hall R, Grocott H, et al. : Cerebral Oximetry Monitoring to Maintain Normal Cerebral Oxygen Saturation during High-risk Cardiac Surgery: A Randomized Controlled Feasibility Trial. Anesthesiology. 2016;124(4):826–36. 10.1097/ALN.0000000000001029
    1. Mazer CD, Whitlock RP, Fergusson DA, et al. : Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery. N Engl J Med. 2017;377(22):2133–44. 10.1056/NEJMoa1711818
    1. Mashour GA, Shanks A, Tremper KK, et al. : Prevention of intraoperative awareness with explicit recall in an unselected surgical population: a randomized comparative effectiveness trial. Anesthesiology. 2012;117(4):717–25. 10.1097/ALN.0b013e31826904a6
    1. Brice DD, Hetherington RR, Utting JE: A simple study of awareness and dreaming during anaesthesia. Br J Anaesth. 1970;42(6):535–42. 10.1093/bja/42.6.535
    1. Tharmanathan P, Calvert M, Hampton J, et al. : The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias. BMC Med Res Methodol. 2008;8:12. 10.1186/1471-2288-8-12
    1. Fleming TR, DeMets DL: Monitoring of clinical trials: issues and recommendations. Control Clin Trials. 1993;14(3):183–97. 10.1016/0197-2456(93)90002-U
    1. Smith MA, Ungerleider RS, Korn EL, et al. : Role of independent data-monitoring committees in randomized clinical trials sponsored by the National Cancer Institute. J Clin Oncol. 1997;15(7):2736–43. 10.1200/JCO.1997.15.7.2736
    1. Montori VM, Devereaux PJ, Adhikari NK, et al. : Randomized trials stopped early for benefit: a systematic review. JAMA. 2005;294(17):2203–9. 10.1001/jama.294.17.2203
    1. Bassler D, Briel M, Montori VM, et al. : Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA. 2010;303(12):1180–7. 10.1001/jama.2010.310
    1. Myles PS, Leslie K, McNeil J, et al. : Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004;363(9423):1757–63. 10.1016/S0140-6736(04)16300-9
    1. Chan MT, Cheng BC, Lee TM, et al. : BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013;25(1):33–42. 10.1097/ANA.0b013e3182712fba
    1. Mashour GA, Esaki RK, Tremper KK, et al. : A novel classification instrument for intraoperative awareness events. Anesth Analg. 2010;110(3):813–5. 10.1213/ANE.0b013e3181b6267d
    1. Sieber FE, Zakriya KJ, Gottschalk A, et al. : Sedation depth during spinal anesthesia and the development of postoperative delirium in elderly patients undergoing hip fracture repair. Mayo Clin Proc. 2010;85(1):18–26. 10.4065/mcp.2009.0469
    1. Radtke FM, Franck M, Lendner J, et al. : Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction. Br J Anaesth. 2013;110 Suppl 1:i98–105. 10.1093/bja/aet055
    1. Chanques G, Payen JF, Mercier G, et al. : Assessing pain in non-intubated critically ill patients unable to self report: an adaptation of the Behavioral Pain Scale. Intensive Care Med. 2009;35(12):2060–7. 10.1007/s00134-009-1590-5
    1. Short TG, Leslie K, Campbell D, et al. : A pilot study for a prospective, randomized, double-blind trial of the influence of anesthetic depth on long-term outcome. Anesth Analg. 2014;118(5):981–6. 10.1213/ANE.0000000000000209
    1. Whitlock EL, Rodebaugh TL, Hassett AL, et al. : Psychological sequelae of surgery in a prospective cohort of patients from three intraoperative awareness prevention trials. Anesth Analg. 2015;120(1):87–95. 10.1213/ANE.0000000000000498
    1. Colak Z, Borojevic M, Bogovic A, et al. : Influence of intraoperative cerebral oximetry monitoring on neurocognitive function after coronary artery bypass surgery: a randomized, prospective study. Eur J Cardiothorac Surg. 2015;47(3)447–54. 10.1093/ejcts/ezu193
    1. Casati A, Fanelli G, Pietropaoli P, et al. : Monitoring cerebral oxygen saturation in elderly patients undergoing general abdominal surgery: a prospective cohort study. Eur J Anaesthesiol. 2007;24(1):59–65. 10.1017/S0265021506001025

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