MIND After Surgery

NCT03785158 | Completed

• 1 other identifier: 5506
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief Summary

Delirium is the most common neurological adverse outcome in elderly surgical patients. It is associated with an increased mortality and morbidity, including need for prolonged hospital stay and institutional care. Despite this, there are no effective preventive strategies. Melatonin is a hormone released from the pineal gland. It is used to improve sleep quality and to treat jet lag. Small studies have suggested that it can decrease the chances of delirium. Since the existing literature is small and uncertain, it is important to test its benefit in a large sample to help guide clinicians. This proposed trial is aimed at testing assessing the feasibility of a large, multi-center, randomized control trial to decrease the incidence of postoperative delirium.

Conditions

Post-operative Delirium; Major Non-cardiac Surgery

Keywords

Delirium; Elderly patients having non-cardiac surgery; Melatonin; sleep quality; sleep deprivation; sleep-wake cycle

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  Recruitment rate: assessed as at least 4-5 patients/week, and completion of recruitment (60 patients/site) in each site over 3-4 months.

  6 months

• Medication compliance

  Proportion of patients who are able to take at least two doses of study medications, assessed as \>85% of study patients.

  8 days

• Follow up to 3 months

  Proportion of patients who complete 3 months follow up. For feasibility we expect \>90% patients to complete study follow up.

  3 months

• Proportion of patients recruited from screening

  To identify the proportion of screened patients meeting the study inclusion criteria

  6 months

Secondary Outcomes (9)

• Incidence of Delirium

  8 days

• Severity of Delirium

  8 days

• Sleep quality

  8 days

• Incidence of ICU care

  8 days

• Prolonged hospital stay

  8 days

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

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.

Other: Liquid Melatonin

Placebo Group

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Liquid Melatonin OTHER

Melatonin is a natural supplement.

Melatonin

Placebo OTHER

Similar looking/tasting placebo syrup

Placebo Group

Eligibility Criteria

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

You may qualify if:

• Age \>65 years
• having a major non-cardiac surgery (which involve major vascular, thoracic, orthopedic, gynecological, otolaryngeal, general and gastrointestinal surgeries) with an expected hospital stay of 2 days or more, and
• ability to provide informed consent

You may not qualify if:

• active delirium or dementia
• ongoing melatonin treatment
• unable to take oral medications
• planned postoperative ventilation
• previous study participation
• allergy to melatonin
• hepatic impairment defined as alanine aminotransferase greater than 500 IU/L
• previous liver transplant or liver cirrhosis of Child-Pugh classes B and C
• not willing to participate
• language barrier

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (2)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Hamilton Health Sciences-Juravinski Hospital Location

Hamilton, Ontario, L8V 1C3, Canada

Location

MeSH Terms

Conditions

Emergence Delirium; Delirium; Sleep Initiation and Maintenance Disorders; Sleep Deprivation

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomised, placebo-controlled, two arm parallel design pilot RCT

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: September 14, 2021
• Primary Completion: July 5, 2025
• Study Completion: July 5, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-07

Locations

CA (2)