Status:
UNKNOWN
Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium
Lead Sponsor:
Tanta University
Conditions:
Dexmedetomidine
Melatonin
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This study aims to compare the effect of dexmedetomidine infusion and oral melatonin on preventing delirium in intensive care unit (ICU) patients.
Detailed Description
Delirium is experienced in 20% to 40% of the critically ill and up to 80% of mechanically ventilated (MV) medical or surgical patients . It is a confessional state that has been described as a transie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06076668
Start Date
October 16 2023
End Date
October 20 2024
Last Update
October 17 2023
Active Locations (1)
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1
Tanta University
Tanta, El-Gharbia, Egypt, 31527