The Healthy Heart-Mind Trial: Efficacy of melatonin for decreasing the incidence and severity of delirium following cardiac surgery

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Delirium is common in patients recovering from surgical procedures, particularly those involving major cardiac surgery. It is associated with numerous adverse consequences, including increased patient suffering, longer hospital stays, increased postoperative complications, increased mortality and poorer cognitive outcomes. Current strategies are only modestly effective in treating delirium and the cornerstone of management is prevention, however even best practice multifactorial interventions only result in a modest reduction in delirium incidence. Melatonin is a naturally occurring compound that is important in the regulation of sleep. Melatonin metabolism dysregulation has been implicated in the development of delirium, although only sparse evidence about its possible role in delirium prevention exists. The main aim of this randomised, placebo-controlled, double blind clinical trial is to determine if 3mg melatonin can reduce the incidence, severity and complications of delirium following cardiac surgery. We plan to enrol 210 participants due to undergo elective cardiac surgery. Participants will be randomly allocated to melatonin 3mg or matching placebo for 7 days beginning two nights prior to the scheduled surgery. We are primarily interested in whether those given melatonin have a lower rate of new-onset delirium but will also be interested to see if they experience less delirious symptoms, less depression and anxiety, less cognitive impairment, require less medications during their admission (especially sedative medications) and have shorter stays in hospital and ICU. Melatonin is safe, inexpensive and readily available and thus offers a potentially simple, cost effective intervention suitable for use in routine clinical practice.