What is the mechanism of action of this treatment?

Melatonin, a hormone that regulates sleep-wake cycles, is being studied for its potential to reduce the incidence of delirium. This is significant for delirium patients because disrupted sleep patterns and circadian rhythms are common in this population. By improving sleep quality and stabilizing circadian rhythms, melatonin may help mitigate cognitive disturbances associated with delirium. Additionally, its antioxidant properties could offer neuroprotective effects, further supporting its potential role in reducing delirium incidence.

What side effects are associated with this type of intervention?

Melatonin, used to regulate sleep-wake cycles and potentially reduce delirium incidence, is generally well tolerated with no serious adverse effects reported, though long-term safety data are limited. Other treatments for delirium, such as antipsychotics, can have side effects including sedation, extrapyramidal symptoms, and cardiovascular issues. Benzodiazepines, another class of drugs sometimes used, can cause sedation, respiratory depression, and dependency. Non-pharmacological interventions like bright light therapy and sleep hygiene practices are also used and have minimal side effects.

What prior FDA approvals exist?

There are no specific FDA-approved medications for the treatment of delirium. Melatonin, which is being studied for its potential to reduce the incidence of delirium by regulating sleep-wake cycles, is not currently FDA-approved for this indication. Other treatments for delirium typically focus on managing symptoms and underlying causes rather than using specific pharmacological agents approved for delirium.

What other types of research exist?

Promising alternatives to melatonin for delirium patients include gabapentin and pregabalin. Both have shown efficacy in improving sleep quality and reducing anxiety, which can be beneficial in managing delirium. Additionally, psychological approaches such as cognitive restructuring and applied relaxation techniques may also be considered as non-pharmacological options.

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Hormone Therapy

Melatonin for Delirium (MIND Trial)

N/A

Waitlist Available

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >65 years

Having a major non-cardiac surgery with an expected hospital stay of 2 days or more

Must not have

Unable to take oral medications

Not willing to participate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

This trial aims to test if melatonin, a natural sleep hormone, can prevent delirium in elderly surgical patients. Delirium is a common and serious issue for these patients, and melatonin might help by improving their sleep. Melatonin is a hormone produced by the pineal gland and has been used successfully for various medical conditions, especially sleep-related diseases.

Who is the study for?

This trial is for people over 65 who are having major non-cardiac surgery and will stay in the hospital for at least two days. They must be able to agree to the study themselves. It's not for those with active delirium or dementia, current melatonin use, trouble taking pills by mouth, planned breathing support after surgery, past study participation, melatonin allergy, severe liver problems, language barriers or unwillingness to participate.

What is being tested?

The MIND After Surgery trial is testing if liquid melatonin can prevent delirium in elderly patients after surgery compared to a placebo (a substance with no active drug). Participants are randomly chosen to receive either melatonin or placebo to see if there's a difference in how often they experience confusion and memory problems post-surgery.

What are the potential side effects?

Melatonin may cause drowsiness, headache, dizziness or nausea. However it's generally considered safe with few side effects when used short-term. The placebo should have no side effects since it doesn't contain any active medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 65 years.

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I am scheduled for a major surgery that is not heart-related and will be in the hospital for at least 2 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take medications by mouth.

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I am not willing to participate in the trial.

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My liver enzyme (ALT) level is above 500 IU/L.

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I am currently taking melatonin.

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I will need help breathing after my surgery.

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I have had a liver transplant or my liver disease is moderate to severe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Follow up to 3 months

Medication compliance

Proportion of patients recruited from screening

+1 more

Secondary study objectives

Adverse effects

Cognitive Status

Incidence of Delirium

+6 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: MelatoninActive Control1 Intervention

3 mg of liquid melatonin by oral route for 8 days. The 1st dose will be given 1-2 hours prior to the surgery, followed by bed time doses (between 7-9 pm) given on postoperative day (POD) 1 until discharge or for the first 7 days.

Group II: Placebo GroupPlacebo Group1 Intervention

Similar looking/tasting 3 mg (5 ml) placebo syrup administered preoperatively by oral route and for the next 7 days or until discharge. The 1st dose will be given 1-2 hours prior to the surgery, followed by bed time doses (between 7-9 pm) given on postoperative day (POD) 1 until discharge or for the first 7 days.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Melatonin, a hormone that regulates sleep-wake cycles, is being studied for its potential to reduce the incidence of delirium. This is significant for delirium patients because disrupted sleep patterns and circadian rhythms are common in this population. By improving sleep quality and stabilizing circadian rhythms, melatonin may help mitigate cognitive disturbances associated with delirium. Additionally, its antioxidant properties could offer neuroprotective effects, further supporting its potential role in reducing delirium incidence.