Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium

Tanta University

Status: Enrolling

Conditions: Delirium; Dexmedetomidine; Melatonin

Treatments: Drug: Melatonin 3 MG; Drug: Dexmedetomidine; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06076668

Dexmedetomidine

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Group D (n=30)

Experimental group

Description:

patients will receive 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.

Treatment:

Drug: Dexmedetomidine

Group M (n=30)

Experimental group

Description:

patients will receive oral melatonin tablet 3 mg at 9:00 p.m.

Treatment:

Drug: Melatonin 3 MG

Control group

Placebo Comparator group

Description:

patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin.

Treatment:

Drug: Saline