Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium

Study Overview
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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.

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.

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

Conditions
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Dexmedetomidine, Melatonin, Delirium

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Melatonin 3 MG
* Drug: Saline


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group D (n=30)<br>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. | Drug: Dexmedetomidine<br>* 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.<br>* Other names: DEX group;|
| Experimental: Group M (n=30)<br>patients will receive oral melatonin tablet 3 mg at 9:00 p.m. | Drug: Melatonin 3 MG<br>* Patients will receive oral melatonin tablet 3 mg 9:00 p.m.<br>* Other names: N-acetyl-5-methoxytryptamine;|
| Placebo Comparator: Control group<br>patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin. | Drug: Saline<br>* Patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin.<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of delirium | The incidence of delirium within 14 days from admission to the intensive care unit (ICU) or until ICU discharge before this time. Every 12 hours throughout the study. | 14 days from admission to intensive care unit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The onset of delirium. • Duration of delirium. • Frequency of delirium. • Length of ICU stay. • Total dose of Haloperidol per day. | Delirium was assessed using Confusion Assessment Method for intensive care unit (CAM- ICU) score at admission to ICU and every 12hr throughout the study. The final CAM-ICU score ranges from 0-7 with 7 being most severe. CAM-ICU-7 scores were further categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium. | 14 days from admission to intensive care unit | 
| Duration of delirium | Delirium was assessed using Confusion Assessment Method for intensive care unit(CAM- ICU) score at admission to ICU and every 12hr throughout the study. The final CAM-ICU score ranges from 0-7 with 7 being most severe. CAM-ICU-7 scores were further categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium. | 14 days from admission to intensive care unit | 
| Frequency of delirium | Delirium was assessed using Confusion Assessment Method for intensive care unit(CAM- ICU)score at admission to ICU and every 12hr throughout the study. The final CAM-ICU score ranges from 0-7 with 7 being most severe. CAM-ICU-7 scores were further categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium. | 14 days from admission to intensive care unit | 
| Total dose of Haloperidol per day | Total dose of Haloperidol per day 14 days from admission to intensive care unit | 14 days from admission to intensive care unit |