Study period | |||||||||||||||||
Timepoints | Enrolment | Allocation | In-hospital | Postoperative follow-up | |||||||||||||
Preoperative | −8 weeks | −1 days | 0.5 hours | 2 hours | 4 hours | 8 hours | 24 hours | 48 hours | 3 days | 4 days | 5 days | 7 days | 1 month | 3 months | 6 months | 12 months | |
Enrolment | |||||||||||||||||
Eligibility screening | X | ||||||||||||||||
Informed consent | X | ||||||||||||||||
Random allocation | X | ||||||||||||||||
Interventions | |||||||||||||||||
Baseline data | X | X | |||||||||||||||
Fluoxetine | X | ||||||||||||||||
Assessments | |||||||||||||||||
MMSE | X | ||||||||||||||||
Neuropsychological evaluation | X | X | X | X | X | ||||||||||||
Postoperative delirium | X | X | X | X | X | X | X | X | X | ||||||||
AUC of the NRS at rest | X | X | X | X | X | X | |||||||||||
AUC of the NRS on movement | X | X | X | X | X | X | |||||||||||
Sleep disturbance | X | X | X | ||||||||||||||
QoR-15 | X | X | X | X | |||||||||||||
Anxiety and depression | X | X | X | ||||||||||||||
Postoperative opioid consumption | X | ||||||||||||||||
CRP | X | X | |||||||||||||||
IL-1β | X | X | |||||||||||||||
Adverse events | X | X | X | X | X | X | X | X | X | X |
AUC, area under the curve; CRP, C reactive protein; IL, interleukin; MMSE, Mini-Mental State Examination; NRS, Numeric Rating Scale; QoR-15, 15-item Quality of Recovery.