Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-16

Study Completion Date

2024-10-20

Brief Summary

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

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Detailed Description

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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

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Dexmedetomidine Melatonin Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group D (n=30)

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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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.

Group M (n=30)

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

Group Type EXPERIMENTAL

Melatonin 3 MG

Intervention Type DRUG

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

Control group

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Melatonin 3 MG

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

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Other Intervention Names

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DEX group N-acetyl-5-methoxytryptamine Control group

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No