EEG Guidance of Anesthesia (ENGAGES-CANADA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-28

Study Completion Date

2023-02-24

Brief Summary

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

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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.

Conditions

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Post-operative Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Anesthesia practitioner is not blinded to intervention. Subject is blinded and primary outcome assessor is blinded to intervention.

Study Groups

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Control Group

Patients will undergo standard anesthesia and will be blinded to EEG-based data, as per standard of care in this patient population.

Group Type NO_INTERVENTION

No interventions assigned to this 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.

Group Type EXPERIMENTAL

EEG-Guided Group

Intervention Type PROCEDURE

Device: Bispectral Index (BIS) processed electroencephalogram or MASIMO or NeuroSENSE

Interventions

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EEG-Guided Group

Device: Bispectral Index (BIS) processed electroencephalogram or MASIMO or NeuroSENSE

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No