Comparing dexmedetomidine and melatonin to prevent delirium in ICU patients

Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Unit (ICU) Delirium; A Prospective Randomized Controlled Study

This study is testing whether an infusion of dexmedetomidine or oral melatonin can help prevent delirium in ICU patients aged 21 and older.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Tanta University (Academic / other)
• Locations: 1 site (Tanta, El-Gharbia)
• Trial ID: NCT06076668 on ClinicalTrials.gov

What this trial studies

This study compares the effectiveness of dexmedetomidine infusion versus oral melatonin in preventing delirium among patients in the intensive care unit (ICU). Delirium is a common and serious condition affecting critically ill patients, leading to longer hospital stays and increased morbidity. The study will enroll patients aged 21 and older who do not have pre-existing delirium or severe neurological conditions. Participants will receive either dexmedetomidine, melatonin, or saline to assess which intervention better reduces the incidence of delirium.

Who should consider this trial

Good fit: Ideal candidates are ICU patients aged 21 and older with healthy gastrointestinal function and no prior delirium or severe mood changes.

Not a fit: Patients with irreversible brain disease, primary neurological conditions, or those expected to stay in the ICU for less than 5 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective method for preventing delirium in critically ill patients, potentially improving their recovery and reducing healthcare costs.

How similar studies have performed: While there have been studies on delirium prevention, the specific comparison of dexmedetomidine and melatonin in this context is relatively novel.

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.

Where this trial is running

Tanta, El-Gharbia

• Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)

Study contacts

• Study coordinator: Eslam Eslam, MD

Conditions Dexmedetomidine; Melatonin; Delirium