Status:
COMPLETED
MIND After Surgery
Lead Sponsor:
McMaster University
Collaborating Sponsors:
St. Joseph's Healthcare Hamilton
Conditions:
Post-operative Delirium
Major Non-cardiac Surgery
Eligibility:
All Genders
65+ years
Phase:
NA
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 instit...
Detailed Description
Delirium is defined as an acute and fluctuating disturbance in cognition characterized by alterations in the level of attention and awareness, which develops over a relative short period of time and r...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2025
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03785158
Start Date
September 14 2021
End Date
July 5 2025
Last Update
September 12 2025
Active Locations (2)
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1
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
2
Hamilton Health Sciences-Juravinski Hospital Location
Hamilton, Ontario, Canada, L8V 1C3