NCT06076668

Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Dexmedetomidine
• Melatonin
• Delirium

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Patients will receive an intravenous dexmedetomidine infusion of 0.2 mcg/kg/h starting at 9 p.m. The infusion will be halved at 6:00 A.M. and discontinued at 6:15 A.M.
DRUG	Melatonin 3 MG	Patients will receive oral melatonin tablet 3 mg 9:00 p.m.
DRUG	Saline	Patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin.

Timeline

• Start date: 2023-10-16
• Primary completion: 2024-10-20
• Completion: 2024-10-20
• First posted: 2023-10-11
• Last updated: 2023-10-17

Locations

1 site across 1 country: Egypt