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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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05640453
Enrollment
70
Registered
2022-12-07
Start date
2022-12-15
Completion date
2026-05-15
Last updated
2025-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Bypass Grafting, Delirium Treatment, Dexmedetomidine, Pregabalin

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.

Interventions

DRUGPregabalin

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

DRUGDexmedetomidine

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percent of delirium treatment24 hour postoperativelyAssessment 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

MeasureTime frameDescription
Level of sedation24 hour postoperativelySedation level will be assessed by using the Ramsey sedation scale.
Incidence of weaning from mechanical ventilation1 week postoperativelypercent of patients who weaned from mechanical ventilation
Length of hospital stay1 month postoperatively

Countries

Egypt

Contacts

Primary ContactIslam Morsy, MD
eslam.morsy@med.tanta.edu.eg00201093387374

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026