Melatonin for Prevention of Post- Operative Delirium Pilot Study Protocol
Status:
Withdrawn
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
To test the efficacy of melatonin compared to placebo in preventing post-operative delirium
and reduction in intensity or duration of delirium in individuals 65 years of age and older
who undergo orthopedic surgery after low energy lower extremity fractures (LELEF).
Biomarkers may play important roles in the detection, prediction and management of delirium
especially in frail elderly individuals. Predictive biomarkers may help characterize an
individual's susceptibility to delirium and thereby help specialized treatment, care and
management of such individuals during their hospitalization. They may also help predict
treatment response to a specific modality and help in selection of such modality. Recent
studies performed in the UK and published in 2011 have measured plasma cholinesterase
activity and determined that these levels were lower in patients who developed delirium
compared with remaining subjects. Other studies have indicated that CRP may also have a role
in delirium prediction as they have found that CRP measured on admission to an ICU had
predictable changes that occurred within 24 hours that in turn were predictors of delirium.
One the aims of the study is to compare the predictive and treatment response values of
groups of biomarkers that have been hypothesized to be of predictive value.