Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting

Study Overview
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Brief Summary
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The aim of this study is to determine the effect of pregabalin versus dexmedetomidine on the treatment and lasting duration of delirium in fast tracking elderly patients after Coronary Artery Bypass Grafting.

Detailed Description
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Delirium is an acute brain disorder that involves changes in consciousness, attention, cognition, and perception.The incidence of postoperative delirium (POD) is high among patients undergoing cardiac surgery, ranging from 20 to 50%, and the risk is even higher in the elderly.

Official Title
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Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting: A Randomized Double-Blind Trial

Conditions
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Pregabalin, Delirium Treatment, Coronary Artery Bypass Grafting, Dexmedetomidine

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CABG patients ≥ 65 years of age both genders American Society of Anesthesiologists (ASA) physical status classification II or III planned for fast track developed postoperative delirium (POD). Exclusion Criteria: Patients who had history of psychiatric diseases; inability to communicate; previous history of POD; preoperative sick sinus syndrome, allergy/sensitivity to pregabalin or dexmedetomidine, severe bradycardia (heart rate <50 beat per minute), second-degree or above atrioventricular block without pacemaker; severe hepatic or renal insufficiency. Previous cardiac or thoracic surgery, known diagnosis of depression or other major psychiatric diseases, cognitive impairment or inability to cooperate with the study, renal insufficiency, and history of substance abuse.

Ages Eligible for Study
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Minimum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pregabalin group<br>Patients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube. | Drug: Pregabalin<br>* Patients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube.<br>|
| Active Comparator: Dexmedetomidine group<br>Patients will receive a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min) followed by an infusion of 0.2 to 0.7 μg/h. | Drug: Dexmedetomidine<br>* Patients will receive a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of delirium treatment | Assessment of delirium will be performed preoperatively and postoperatively at 12-h intervals or as needed according to the patient's condition using the confusion assessment method (CAM) | 24 hour postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of sedation | Sedation level will be assessed by using the Ramsey sedation scale. | 24 hour postoperatively | 
| Incidence of weaning from mechanical ventilation | percent of patients who weaned from mechanical ventilation | 1 week postoperatively | 
| Length of hospital stay |  | 1 month postoperatively |