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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT06076668
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 21 years or older.
* Either gender.
* Healthy gastrointestinal function (patients tolerated oral medications by gavage or mouth).
* Richmond Agitation Sedation Scale (RASS) \>-1.
* No basic delirium or mood changes before admission to intensive care unit(ICU).
Exclusion Criteria:
* Patient refusal.
* History of irreversible brain disease consistent with severe dementia.
* Patient admitted with a primary neurologic condition or injury (e.g., intracranial hemorrhage).
* Heart rate (HR) less than 50 beats/ min or second- third degree heart block in the absence of a pacemaker.
* Acute alcohol withdrawal requiring benzodiazepine administration.
* History of hepatic encephalopathy or end-stage liver disease (Child-Pugh class B or C).
* The expected duration of intensive care unit (ICU) stay less than 5 days.
* Inability to obtain informed consent.
* Pregnancy.
* Allergy to dexmedetomidine or melatonin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT06076668
Study Brief:
Protocol Section:
NCT06076668