Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT03785158
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT03785158
Study Brief:
Protocol Section:
NCT03785158