Clinical trial NCT02692300: EEG Guidance of Anesthesia (ENGAGES-CANADA)
Official title: Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES-CANADA) Study: a Pragmatic, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Delirium
Keywords: anesthesia
delirium
surgery
electroencephalography
burst suppression
PTSD
anxiety
depression
falls
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Queen's University
name: University of Washington
name: University of Toronto
name: Université de Montréal
First posted: 2016-02-26
Enrollment: 1225
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of post-operative delirium
timeFrame: 5 days
Secondary outcomes:
measure: Incidence of mortality at 30 days and at 1 year
timeFrame: 30 days, 1 year
measure: Length of ICU stay
timeFrame: Time (days) in ICU from Post-Operative Day (POD) 1 to 5 (or through study completion at one year)
measure: Length of Hospital stay
timeFrame: Time (days) from admission to discharge from hospital (or through study completion at one year)
Other outcomes:
measure: Incidence of falls at 30 days and 1 year
timeFrame: 30 days, 1 year
measure: Duration of delirium
timeFrame: 5 days
measure: Severity of delirium
timeFrame: 5 days
measure: Association between delirium and falls
timeFrame: 30 days and 1 year
measure: Association between delirium and quality of life by PROMIS Global Health
timeFrame: 30 days and 1 year
measure: Predictors and outcomes of perioperative dissociation by PDEQ at 5 days and 30 days postoperatively.
timeFrame: 5 day and 30 days
measure: Predictors and outcomes of perioperative distress by PDI at 5 days and 30 days postoperatively
timeFrame: 5 days and 30 days
measure: Association between depth of anesthesia by EEG monitoring and mortality rate
timeFrame: 1 year
measure: Predictors of Post-Traumatic Stress Disorder (PTSD) using the Post-Traumatic Checklist for DSM-5 (PCL-5).
timeFrame: 30 days and 1 year
measure: Incidence of major intraoperative and postoperative complications.
timeFrame: Up to 30 days post surgery
Locations:
city: Montréal
country: Canada
facility: Montreal Heart Institute, Université de Montréal
state: Quebec
Study officials:
affiliation: University of Manitoa
name: Eric Jacobsohn, MBChB FRCPC
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Michael Avidan, MBBCh FCASA
role: STUDY_DIRECTOR
affiliation: Queens University
name: Tarit Saha, MD FRCPC
role: STUDY_DIRECTOR
affiliation: Université de Montréal
name: Alain Deschamps, PhD MD FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: George Djaiani, MD
role: STUDY_DIRECTOR
affiliation: University of Manitoba
name: Renée El-Gabalawy, MA PhD
role: STUDY_DIRECTOR
References:
citation: Deschamps A, Saha T, El-Gabalawy R, Jacobsohn E, Overbeek C, Palermo J, Robichaud S, Dumont AA, Djaiani G, Carroll J, Kavosh MS, Tanzola R, Schmitt EM, Inouye SK, Oberhaus J, Mickle A, Ben Abdallah A, Avidan MS, Clinical Trials Group CPA. Protocol for the electroencephalography guidance of anesthesia to alleviate geriatric syndromes (ENGAGES-Canada) study: A pragmatic, randomized clinical trial. F1000Res. 2019 Jul 23;8:1165. doi: 10.12688/f1000research.19213.2. eCollection 2019.