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:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT03977350
Eligibility Criteria:
Inclusion Criteria:
* Males and females between the ages of 65 or above.
* Subjects with American Society of Anesthesiologists physical status I-III.
* Subjects who are intended to undergo cardiac surgery (CABG or valve replacement) under general anesthesia.
* Surgical procedures scheduled for over 30 minutes.
* Lack of significant hearing disturbances.
* Subjects with ability to read and understand the consent form.
Exclusion Criteria:
* Significant visual impairment so that the pictures of the confusion assessment method could not be interpreted to accurately test to assess delirium.
* Profound dementia or aphasia that interfered with the assessment of cognitive dysfunction (positive delirium in CAM-ICU).
* Patients with a history of stroke.
* Any documented major neurologic or psychiatric dysfunction.
* Pregnant women.
* Long term use of sedative-hypnotic drugs and antidepressant drug.
* Subjects with scalp or skull abnormalities (s/p brain surgery, cranial implants).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT03977350
Study Brief:
Protocol Section:
NCT03977350