Table 2.

Study procedures

Procedure	Screening	Baseline	Surgery	Postoperative day number								1 and 6 months
	≤30 days before day 0	−3 to −1 days before day 0	Day 0	1	2	3	4	5	6	7	Hospital discharge
Informed consent	X
Assessment of eligibility	X
Routine blood tests (ie, creatinine, liver transaminases, albumin, troponin, proBNP)	X										X
ECG	X			X
Physical examination	X
Past and current medical conditions	X											X
Vital signs	X	X	X	X	X	X	X	X	X	X
Randomisation		X
Prescribed medications		X
Demographic data		X										X
Blood samples for biomarkers		X		X		X		X
ASA classification and Euroscore II		X
Cognitive assessments		X										X
Frailty assessments		X										X
PROM (EQ-5D-5L)		X										X
Body-worn accelerometers (St Olav only)		X		X	X	X	X	X	X	X	X	X
Study intervention			X	X
Safety review (including haemodynamic variables, AE/SAE review, death)			X	X	X	X	X	X	X	X		X
Postoperative variables (eg, vital signs, medications, transfusions, re-operations, respiratory support)				X	X	X	X	X	X	X
Routine assessments of delirium, 3×/day (by nursing staff); CAM-ICU, RASS			X	X	X	X	X	X	X	X
Delirium assessments DSM-5 based, 1×/day (by research assistant)				X	X	X	X	X	X	X		X*
Pain assessment (NRS)				X	X	X	X	X	X	X
Registration of per-operative variables (eg, type of surgery, medications, transfusions, vital parameters, duration of surgery/anaesthesia)											X
Registration of postoperative complications											X
Registration of total dose and duration of study medication											X

*No delirium assessment at follow-up after 6 months.

AE, adverse event; ASA, American Society of Anesthesiologists; CAM-ICU, confusion assessment method for intensive care unit; DSM-5, Diagnostic and Statistical Manual of Mental Disorders, fifth edition; NRS, Numerical Rating Scale; proBNP, pro-B-type natriuretic peptide; PROM, patient-rated outcome measure; RASS, Richmond Agitation Sedation Scale; SAE, serious AE.