Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dexmedetomidine; Coronary Artery Bypass Grafting; Pregabalin; Delirium Treatment
• Intervention / Treatment: Drug: Pregabalin; Drug: Dexmedetomidine

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Islam Morsy, MD; Phone Number: 00201093387374; Email: eslam.morsy@med.tanta.edu.eg

Study Locations

• Egypt
  • El-Gharbia Governorate
    • Tanta, El-Gharbia Governorate, Egypt
      • Recruiting
      • Islam Morsy
      • Contact: Islam Morsy, MD; Phone Number: 139 00201093387374; Email: eslam.morsy@med.tanta.edu.eg
      • Sub-Investigator: Mohammed S El Sharkawy, MD
      • Sub-Investigator: Hussein G Almawardy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of sedation	Sedation level will be assessed by using the Ramsey sedation scale.	24 hour postoperatively
Incidence of weaning from mechanical ventilation	percent of patients who weaned from mechanical ventilation	1 week postoperatively
Length of hospital stay		1 month postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Membrane Transport Modulators; Hypnotics and Sedatives; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Anticonvulsants; Calcium Channel Blockers; Pregabalin; Dexmedetomidine
• Other Study ID Numbers: 35912/10/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will available upon reasonable request from the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No