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NCT Number: NCT05640453

Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting

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.

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Key information

Conditions

Pregabalin Coronary Artery Bypass Grafting Delirium Treatment Dexmedetomidine

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Islam Morsy

Tanta, El-Gharbia Governorate, Egypt

Location status: Recruiting

Location contact

Hussein G Almawardy, MD

SUB_INVESTIGATOR

Islam Morsy, MD

CONTACT

[email protected]

00201093387374 ext. 139

Mohammed S El Sharkawy, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pregabalin

Drug

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

Dexmedetomidine

Drug

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

Primary outcomes

  1. Percent of delirium treatment

    Time frame: 24 hour postoperatively

    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)

Secondary outcomes

  1. Level of sedation

    Time frame: 24 hour postoperatively

    Sedation level will be assessed by using the Ramsey sedation scale.

  2. Incidence of weaning from mechanical ventilation

    Time frame: 1 week postoperatively

    percent of patients who weaned from mechanical ventilation

  3. Length of hospital stay

    Time frame: 1 month postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Islam Morsy, MD

CONTACT

[email protected]

00201093387374

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 7, 2022
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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