Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting

Tanta University

Status and phase: Enrolling; Phase 4

Conditions: Dexmedetomidine; Delirium Treatment; Pregabalin; Coronary Artery Bypass Grafting

Treatments: Drug: Pregabalin; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05640453

35912/10/22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Pregabalin group

Active Comparator group

Description:

Patients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube.

Treatment:

Drug: Pregabalin

Dexmedetomidine group

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine