Treating delirium after coronary bypass with pregabalin versus dexmedetomidine
Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting: A Randomized Double-Blind Trial
This study will test whether pregabalin or dexmedetomidine works better to treat delirium in patients aged 65 and older after coronary artery bypass grafting.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia Governorate) |
| Trial ID | NCT05640453 on ClinicalTrials.gov |
What this trial studies
Older patients (≥65) undergoing coronary artery bypass grafting who develop postoperative delirium in a fast-track pathway receive either pregabalin or dexmedetomidine as the intervention. The trial compares the two drugs' effects on the duration and course of postoperative delirium, using clinical assessments of consciousness and cognition during the hospital stay. Eligibility is limited to ASA II–III patients and excludes those with severe organ failure, significant conduction abnormalities, prior major psychiatric disease, or allergies to the study drugs. The interventions are administered in the postoperative period at Tanta University Hospital and outcomes include delirium duration and recovery metrics.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 or older undergoing CABG with ASA II–III classification who develop postoperative delirium and meet the study's inclusion and exclusion criteria.
Not a fit: Patients with severe hepatic or renal insufficiency, significant bradycardia or high‑grade AV block without a pacemaker, prior major psychiatric disease or cognitive impairment, or allergy to pregabalin or dexmedetomidine are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, the comparison could identify a safer or more effective option to shorten delirium episodes and speed recovery after CABG in elderly patients.
How similar studies have performed: Dexmedetomidine has previous evidence suggesting reductions in postoperative or ICU delirium, while pregabalin has been less studied for delirium, so this head‑to‑head comparison is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tanta, El-Gharbia Governorate
- Islam Morsy — Tanta, El-Gharbia Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Islam Morsy, MD
- Email: eslam.morsy@med.tanta.edu.eg
- Phone: 00201093387374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.