Melatonin for Delirium
(MIND Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: McMaster University

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am older than 65 years.

Ability to provide informed consent

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

I cannot take medications by mouth.

I am not willing to participate in the trial.

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

+7 more

Participant Groups

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.

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.