Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting

NCT ID: NCT05640453

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2026-05-15

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.

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.

Conditions

Pregabalin; Delirium Treatment; Coronary Artery Bypass Grafting; Dexmedetomidine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pregabalin group

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

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

Patients will receive a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min)

Interventions

Pregabalin

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

Intervention Type: DRUG

Dexmedetomidine

Patients will receive a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Islam Morsy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Islam Morsy

Tanta, El-Gharbia Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Islam Morsy, MD

Role: CONTACT

eslam.morsy@med.tanta.edu.eg

00201093387374

Facility Contacts

Islam Morsy, MD

Role: primary

eslam.morsy@med.tanta.edu.eg

00201093387374 ext. 139

Other Identifiers

35912/10/22

Identifier Type: -

Identifier Source: org_study_id