This is a pragmatic, participant-blinded, multicentre, parallel-group, randomised controlled trial with SHSC, a tertiary academic centre in Canada, as the coordinating site. The pilot trial demonstrated the ability to recruit 44 participants over 1 year and collect baseline and primary outcome data (ie, major P-NCD assessment at 3 months).

The multicentre trial was launched in December 2019 with the unanalysed data from the pilot trial included in the full trial. Recruitment will be finished after 2400 participants have completed 1-year follow-up (projected 2027). Individuals awaiting elective cardiac surgery are approached either on the cardiology ward or in the preoperative anaesthesia clinic of the participating sites by trained personnel. Those providing informed, written consent are then screened using the preoperative baseline CBB. If pre-existing cognitive dysfunction is absent, participants are randomised to one of two treatment arms (figure 1 and table 1). Participants will be able to withdraw from the study at their prerogative at any time, and no further data will be collected.

CODEX trial workflow: schedule of enrolment, interventions and assessments. BPI, Brief Pain Inventory; CAM, Confusion Assessment Method; CBB, Cogstate Brief Battery;; HHS, Hamilton Health Sciences; LHSC, London Health Sciences Centre; NCD, neurocognitive disorder; PHQ, Patient Health Questionnaire; QoR-40, Quality of Recovery-40 Scale; TGH, Toronto General Hospital. *Current participating centres.

Eligibility criteria

 Age ≥60 years

 Elective CABG (±valve, including off-pump) or valve replacement

 Lack of patient consent

 Medical history of the following:

 Pre-existing major cognitive dysfunction (CBB score <80 adjusted to general population’s age-matched controls).

 Contraindication to DEX (per product monograph).

 History of drug/alcohol abuse.

 Renal and hepatic dysfunction.

 Surgical procedures requiring deep hypothermic circulatory arrest

 Unlikely to comply with study assessments (ie, cannot complete cognitive tests at the follow-up time points)

CABG, coronary artery bypass grafting; CBB, Cogstate Brief Battery; DEX, dexmedetomidine.

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