Protocol for the electroencephalography guidance of anesthesia to alleviate geriatric syndromes (ENGAGES-Canada) study: A pragmatic, randomized clinical trial

Alain Deschamps; Tarit Saha; Renée El-Gabalawy; Eric Jacobsohn; Charles Overbeek; Jennifer Palermo; Sophie Robichaud; Andrea Alicia Dumont; George Djaiani; Jo Carroll; Morvarid S Kavosh; Rob Tanzola; Eva M Schmitt; Sharon K Inouye; Jordan Oberhaus; Angela Mickle; Arbi Ben Abdallah; Michael S Avidan; Canadian Perioperative Anesthesia Clinical Trials Group

doi:10.12688/f1000research.19213.2

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.

Authors

Alain Deschamps¹, Tarit Saha², Renée El-Gabalawy³, Eric Jacobsohn⁴, Charles Overbeek⁵, Jennifer Palermo⁵, Sophie Robichaud⁶, Andrea Alicia Dumont⁷, George Djaiani⁸, Jo Carroll⁸, Morvarid S Kavosh⁹, Rob Tanzola², Eva M Schmitt¹⁰, Sharon K Inouye¹⁰, Jordan Oberhaus¹¹, Angela Mickle¹¹, Arbi Ben Abdallah¹¹, Michael S Avidan¹¹, Canadian Perioperative Anesthesia Clinical Trials Group¹²

Affiliations

¹ Department of Anesthesiology and Pain Medicine, Montreal Heart Institute and Universite de Montreal, Montreal, Quebec, H1T 1C8, Canada.
² Department of Anesthesiology and Perioperative Medicine, Queen's University, Kingston, Kingston, Ontario, Canada.
³ Department of Clinical Health Psychology, Anesthesiology, Perioperative and Pain Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
⁴ Departments of Anesthesia and Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
⁵ Department of Anesthesiology and Pain Medicine, University of Montreal, Montreal, Quebec, Canada.
⁶ Montreal Heart Institute, Montreal, Quebec, H1T 1C8, Canada.
⁷ Montreal Health Innovation Coordinating Center, Montreal Heart Institute, Montreal, Quebec, Canada.
⁸ Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada.
⁹ Department of Anesthesiology, Perioperative and Pain Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
¹⁰ Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachussetts, USA.
¹¹ Department of Anesthesiology, Washington University School of Medicine, St-Louis, Missouri, USA.
¹² Department of Anesthesia, University of Manitoba, Winnipeg, Manitoba, Canada.

Abstract

Background: There is some evidence that electroencephalography guidance of general anesthesia can decrease postoperative delirium after non-cardiac surgery. There is limited evidence in this regard for cardiac surgery. A suppressed electroencephalogram pattern, occurring with deep anesthesia, is associated with increased incidence of postoperative delirium (POD) and death. However, it is not yet clear whether this electroencephalographic pattern reflects an underlying vulnerability associated with increased incidence of delirium and mortality, or whether it is a modifiable risk factor for these adverse outcomes. Methods: The Electroe ncephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes ( ENGAGES-Canada) is an ongoing pragmatic 1200 patient trial at four Canadian sites. The study compares the effect of two anesthetic management approaches on the incidence of POD after cardiac surgery. One approach is based on current standard anesthetic practice and the other on electroencephalography guidance to reduce POD. In the guided arm, clinicians are encouraged to decrease anesthetic administration, primarily if there is electroencephalogram suppression and secondarily if the EEG index is lower than the manufacturers recommended value (bispectral index (BIS) or WAVcns below 40 or Patient State Index below 25). The aim in the guided group is to administer the minimum concentration of anesthetic considered safe for individual patients. The primary outcome of the study is the incidence of POD, detected using the confusion assessment method or the confusion assessment method for the intensive care unit; coupled with structured delirium chart review. Secondary outcomes include unexpected intraoperative movement, awareness, length of intensive care unit and hospital stay, delirium severity and duration, quality of life, falls, and predictors and outcomes of perioperative distress and dissociation. Discussion: The ENGAGES-Canada trial will help to clarify whether or not using the electroencephalogram to guide anesthetic administration during cardiac surgery decreases the incidence, severity, and duration of POD. Registration: ClinicalTrials.gov ( NCT02692300) 26/02/2016.

Keywords: EEG suppression; anesthetic management; cardiac surgery; cardiopulmonary bypass; geriatric outcomes; perioperative risk factors; postoperative delirium; volatile anesthetics.

Associated data

ClinicalTrials.gov/NCT02692300

Grants and funding

Funding for the ENGAGES-Canada trial is through the Canadian Institute of Health Research (CIHR) [159482] and from departmental funding at participating sites. The Dr. Seymour and Rose T. Brown Endowed Chair are providing funding at the Washington University site.