Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting

NCT05640453 | Recruiting Phase 4

• 1 other identifier: 35912/10/22
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregabalin; Delirium Treatment; Coronary Artery Bypass Grafting; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Percent of delirium treatment

  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)

  24 hour postoperatively

Secondary Outcomes (3)

• Level of sedation

  24 hour postoperatively

• Incidence of weaning from mechanical ventilation

  1 week postoperatively

• Length of hospital stay

  1 month postoperatively

Study Arms (2)

Pregabalin group

ACTIVE COMPARATOR

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

Drug: Pregabalin

Dexmedetomidine group

ACTIVE COMPARATOR

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

Interventions

Pregabalin DRUG

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

Pregabalin group

Dexmedetomidine DRUG

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

Dexmedetomidine group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Islam Morsy

Tanta, El-Gharbia Governorate, Egypt

RECRUITING

MeSH Terms

Interventions

Pregabalin; Dexmedetomidine

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Islam Morsy, MD

CONTACT

00201093387374; eslam.morsy@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: December 15, 2022
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)