Actively Recruiting
Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting: A Randomized Double-Blind Trial
Led by Tanta University · Updated on 2025-06-25
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of pregabalin versus dexmedetomidine on treating and prolonging the duration of delirium in elderly patients undergoing Coronary Artery Bypass Grafting (CABG). Delirium is a sudden brain disorder affecting consciousness, attention, and perception, and it is common after cardiac surgery, especially in older adults. This study aims to compare these two drugs to understand their impact on postoperative delirium in patients aged 65 and older. Participants will be randomly assigned to receive either pregabalin capsules (75 mg) every 12 hours for 24 hours through a nasogastric tube or a bolus dose of dexmedetomidine (0.4 µg/kg over 10 to 20 minutes) followed by a continuous infusion of 0.2 to 0.7 µg/hour. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The trial focuses on fast-tracking elderly CABG patients for postoperative delirium treatment. During the study, researchers will monitor the percentage of patients with delirium treated 24 hours after surgery as the primary outcome. They will also assess sedation levels at 24 hours, the rate of weaning from mechanical ventilation within one week, and hospital stay length measured at one month postoperatively. Participants will be closely observed and evaluated through these measures to understand the treatments' effects and safety over time.
CONDITIONS
Brief Title
Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 65 years or older undergoing Coronary Artery Bypass Grafting (CABG)
- Both genders included
- American Society of Anesthesiologists (ASA) physical status classification II or III
- Planned for fast-track postoperative care
- Developed postoperative delirium (POD)
You will not qualify if you...
- History of psychiatric diseases or inability to communicate
- Previous history of postoperative delirium (POD)
- Preoperative sick sinus syndrome
- Allergy or sensitivity to pregabalin or dexmedetomidine
- Severe bradycardia (heart rate below 50 beats per minute)
- Second-degree or higher atrioventricular block without pacemaker
- Severe liver or kidney insufficiency
- Previous cardiac or thoracic surgery
- Known diagnosis of depression or other major psychiatric diseases
- Cognitive impairment or inability to cooperate with the study
- History of substance abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 hours
Participants receive either pregabalin capsules every 12 hours for 24 hours by nasogastric tube or a bolus dose of dexmedetomidine followed by an infusion for delirium treatment after coronary artery bypass grafting.
Continuous treatment during the 24-hour period
Duration - Up to 1 month postoperatively
Participants are monitored for sedation level, mechanical ventilation weaning, and length of hospital stay after treatment.
Assessments at 24 hours, 1 week, and up to 1 month postoperatively
Trial Site Locations
Total: 1 location
1
Islam Morsy
Tanta, El-Gharbia Governorate, Egypt
Actively Recruiting
Research Team
I
Islam Morsy, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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