EEG Guidance of Anesthesia (ENGAGES-CANADA)

Study Overview
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Brief Summary
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This study examines the potential link between deep levels of anesthesia and delirium.

Detailed Description
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ENGAGES CANADA is a parallel study to the ENGAGES study which has been published in JAMA, DOI:10.1001/jama.2019.5161. Due to the difference in practice models and types of anesthesia principles, ENGAGES CANADA is an important study. Delirium is a relatively common postoperative complication in the geriatric population, affecting 20% to 70% of surgical patients over the age of 60. Delirium manifests as confusion, inattention and the inability to think logically, and may affect the patient's postoperative healing and rehabilitation. It is associated with persistent cognitive decline, longer hospital stay, increased incidence of injurious falls, and increased mortality. Patients undergoing major cardiac surgery are at a significant risk of postoperative delirium. To date, there is no proven method to prevent postoperative delirium in this patient population and often delirious events remain unrecognized. Randomized controlled studies in diverse surgical patient populations suggest that intraoperative electroencephalography (EEG) guidance during general anesthesia may decrease postoperative delirium and adverse postoperative outcomes. Patients who experience postoperative delirium report persistently decreased quality of life and it is a risk factor for incident psychiatric disorders and psychotropic medication use. One potential key mechanism in the relationship between delirium and incident psychiatric illness may be the experience of dissociation (disturbed awareness, impaired memory, or altered perceptions) in the perioperative period in those who are delirious. The co-occurrence of psychiatric illness and delirium can put older adults at greater risk of negative long terms effect such as functional decline. This study will compare the effectiveness of two anesthetic protocols in reducing postoperative delirium and postoperative health-related quality of life in a high risk population.We expect that EEG-guided anesthetic management of patients during their operative procedure will result in improved health-related outcomes, specifically decreased incidence of postoperative delirium and improved postoperative mental and physical health outcomes.

Official Title
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Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES-CANADA) Study: a Pragmatic, Randomized Clinical Trial

Conditions
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Post-operative Delirium

Intervention / Treatment
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* Procedure: EEG-Guided Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 60 years or older; Competent to provide informed consent; Undergoing elective cardiac surgery requiring cardiopulmonary bypass. Exclusion Criteria: Unable to provide informed consent; Preoperative delirium; Unable to participate adequately in delirium screening including those who are blind, deaf, illiterate or not fluent English or French; History of intraoperative awareness

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Patients will undergo standard anesthesia and will be blinded to EEG-based data, as per standard of care in this patient population. | |
| Experimental: EEG-Guided Group<br>Practitioners will follow the EEG-Guided protocol to limit the incidence of EEG burst suppression by decreasing administration of anesthesia. The EEG-guided protocol is suggestive rather than prescriptive, and practitioners will exercise judgment depending on the clinical situation. | Procedure: EEG-Guided Group<br>* Device: Bispectral Index (BIS) processed electroencephalogram or MASIMO or NeuroSENSE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-operative delirium | Incidence of delirium will be compared between the Control Group and the EEG-Guided Group as measured by the numbers of positive Confusion Assessment Method (CAM) or CAM for intensive care unit (CAM-ICU) scores, coupled with Chart Review. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of mortality at 30 days and at 1 year | Incidence of mortality (%) will be compared between the Control Group and the EEG-Guided Group at 30 days and at 1 year | 30 days, 1 year | 
| Length of ICU stay | Length of ICU stay (days) will be compared between the Control Group and the EEG-Guided Group. | Time (days) in ICU from Post-Operative Day (POD) 1 to 5 (or through study completion at one year) | 
| Length of Hospital stay | Length of hospital stay (days) will be compared between the Control Group and the EEG-Guided Group. | Time (days) from admission to discharge from hospital (or through study completion at one year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthesia, delirium, surgery, electroencephalography, burst suppression, PTSD, anxiety, depression, falls