Melatonin for Prevention of Post- Operative Delirium Pilot Study Protocol

NCT02903901 | Withdrawn Phase 4

• 1 other identifier: 206981
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delirium

Keywords

Delirium

Outcome Measures

Primary Outcomes (1)

• Delirium assessment

  The Delirium Rating Scale Revised (DRS-R98) will be given to all patients every day for seven days. Investigators will compare the scores recorded on day 7 between those receiving melatonin versus those receiving placebo controlling for their baseline performance.

  1 Week

Secondary Outcomes (1)

• Hospital stay

  1 Week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Individuals who are randomized to the control arm will receive liquid placebo sublingually 60-90 minutes prior to surgery.

Drug: Placebo

Melatonin

ACTIVE COMPARATOR

Individuals who are randomized to the treatment arm will receive 10 mg liquid IR-SL melatonin 60-90 minutes prior to surgery

Drug: Melatonin

Interventions

Melatonin DRUG

10 mg liquid Melatonin IR-SL at 7 pm for 1 week

Melatonin

Placebo DRUG

10 mg liquid placebo at 7 pm for 1 week

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (2)

• Deiner S, Silverstein JH. Postoperative delirium and cognitive dysfunction. Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i41-46. doi: 10.1093/bja/aep291.

  PMID: 20007989 BACKGROUND

• Bekker AY, Weeks EJ. Cognitive function after anaesthesia in the elderly. Best Pract Res Clin Anaesthesiol. 2003 Jun;17(2):259-72. doi: 10.1016/s1521-6896(03)00005-3.

  PMID: 12817919 BACKGROUND

MeSH Terms

Conditions

Delirium

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Muralidhara S Rao, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 16, 2016
• Study Start: June 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 16, 2016

Record last verified: 2016-09

Locations

US (1)