Clinical trial

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

Name
35912/10/22
Description
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.
Trial arms
Trial start
2022-12-15
Estimated PCD
2023-05-15
Trial end
2023-05-15
Status
Recruiting
Phase
Early phase I
Treatment
Pregabalin
Patients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube.
Arms:
Pregabalin group
Dexmedetomidine
Patients will receive a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min)
Arms:
Dexmedetomidine group
Size
70
Primary endpoint
Percent of delirium treatment
24 hour postoperatively
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}
Updated at
2023-04-18

1 organization

2 products

4 indications

Organization
Tanta University
Product
Pregabalin
Indication
Pregabalin
Indication
Delirium
Indication
Dexmedetomidine