Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Pregabalin group Patients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube. |
Drug: Pregabalin
Patients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube.
|
| Active Comparator: Dexmedetomidine group 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
Patients will receive a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min)
|
Outcome Measures
Primary Outcome Measures
- Percent of delirium treatment [24 hour postoperatively]
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)
Secondary Outcome Measures
- Level of sedation [24 hour postoperatively]
Sedation level will be assessed by using the Ramsey sedation scale.
- Incidence of weaning from mechanical ventilation [1 week postoperatively]
percent of patients who weaned from mechanical ventilation
- Length of hospital stay [1 month postoperatively]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Islam Morsy | Tanta | El-Gharbia Governorate | Egypt |
Sponsors and Collaborators
- Tanta University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 35912/10/22