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Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium

Recruiting
21 years of age
Both
Phase N/A

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Overview

This study aims to compare the effect of dexmedetomidine infusion and oral melatonin on preventing delirium in intensive care unit (ICU) patients.

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 transient global disorder of cognition, awareness, and attention and as such is not only challenging for the treating medical team, but also has a considerable impact on affected patients. It is associated with prolonged hospital length of stay and time on MV, deterioration in cognition, and increased morbidity and mortality causing additional health-care expenses.

Eligibility

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.

Study details

Dexmedetomidine, Melatonin, Delirium

NCT06076668

Tanta University

26 January 2024

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