EEG Guidance of Anesthesia (ENGAGES-CANADA)

Not Applicable

Completed

• Conditions: Post-operative Delirium
• Interventions: Procedure: EEG-Guided Group

• Registration Number: NCT02692300
• Lead Sponsor: University of Manitoba

Brief Summary

This study examines the potential link between deep levels of anesthesia and delirium.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-26
• Study Start: 2016-12-28
• Primary Completion: 2022-02-24
• Study Completion: 2023-02-24
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1225

Inclusion Criteria

1. Adults 60 years or older;
2. Competent to provide informed consent;
3. Undergoing elective cardiac surgery requiring cardiopulmonary bypass.

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Exclusion Criteria

1. Unable to provide informed consent;
2. Preoperative delirium;
3. Unable to participate adequately in delirium screening including those who are blind, deaf, illiterate or not fluent English or French;
4. History of intraoperative awareness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EEG-Guided Group	EEG-Guided Group	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.

Primary Outcome Measures

Name	Time	Method
Incidence of post-operative delirium	5 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Montreal Heart Institute, Université de Montréal; 🇨🇦 Montréal, Quebec, Canada