Melatonin for Prevention of Post- Operative Delirium Pilot Study Protocol

• Status: Withdrawn
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Patients 65 years of age and older undergoing Low Energy Lower Extremity Fractures (LELEF) surgery

• Presence of an LELEF fracture

• Low Energy (e.g., falls from standing height, falls from sitting, etc.).

• Operative Fractures:

• Pathologic femur and tibia fractures

• Femoral neck fractures

• Pertroch: including intertroch, subtroch fractures

• Femoral shaft

• Supracondylar femur fractures

• Periprosthetic fractures around total hip and total knee arthroplasties

• Tibial plateau fractures

• Proximal Tibia Fractures

• Tibial Shaft Fractures

• Distal 1/3 tibia fractures

• Ankle Fractures that are admitted

Exclusion Criteria:

• Patients with previous adverse reaction or side-effects to melatonin

• Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

• Inability to communicate in English

• Patients with a Montreal Cognitive Assessment (MoCA) score of below 7 will not be included in the study because of their inability to give informed consent at that stage. This score is approximately 2 standard deviation below average score for Alzheimer's Dementia.

• Participants who are unable to give consent or communicate well in English will not be enrolled