Montreal Heart Institute, Université de Montréal
Montreal, Quebec, H1T 1C8, Canada
NCT Number: NCT02692300
This study examines the potential link between deep levels of anesthesia and delirium.
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Montreal, Quebec, H1T 1C8, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Device: Bispectral Index (BIS) processed electroencephalogram or MASIMO or NeuroSENSE
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 30 days, 1 year
Number of falls will be recorded by patient interview at 30 days and 1 year, compared between the Control Group and the EEG-Guided Group.
Time frame: 5 days
Time (days) measured between the first and last positive CAM assessments and compared between the Control Group and the EEG-Guided Group.
Time frame: 5 days
Severity of delirium will be compared between the Control Group and the EEG-Guided Group. As assessed by the CAM-S severity score
Time frame: 30 days and 1 year
The overall incidence of delirium as assessed by CAM vs the incidence of falls by an adjusted regression model.
Time frame: 30 days and 1 year
The overall incidence of delirium as assessed by CAM vs quality of life as assessed by the PROMIS Global Health measure, by an adjusted regression model.
Time frame: 5 day and 30 days
A regression model will be used to assess independent predictors of dissociation as assessed by the PDEQ measure, and mental health outcomes associated with perioperative dissociation.
Time frame: 5 days and 30 days
A regression model will be used to assess independent predictors of PTSD as assessed by the PDI measure.
Time frame: 1 year
Depth of anesthesia measured by BIS, Medline, or MASIMO monitors vs mortality rate by an adjusted regression model.
Time frame: 30 days and 1 year
A regression model will be used to assess independent predictors of PTSD as assessed by the PCL-5 measure. This score predicts the risk of PTSD from 0, negligible risk, to 80, extremely high risk of PTSD in patients.
Time frame: Up to 30 days post surgery
Undesirable intraoperative movement, awareness with recall, complications such as major blood loss and transfusions, stroke, sternal wound infection, sepsis, dialysis, prolonged intubation
University of Manitoba
Other
Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES-CANADA) Study: a Pragmatic, Randomized Clinical Trial
Acronym: ENGAGES
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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