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Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting

ConditionsPregabalinDelirium TreatmentCoronary Artery Bypass GraftingDexmedetomidine
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorTanta University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Pregabalin groupActive comparator 1 intervention
Group B: Dexmedetomidine groupActive comparator 1 intervention

Trial outcomes

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)

Time frame
24 hour postoperatively

Secondary outcomes

1

Level of sedation

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

Time frame
24 hour postoperatively
2

Incidence of weaning from mechanical ventilation

percent of patients who weaned from mechanical ventilation

Time frame
1 week postoperatively
3

Length of hospital stay

Time frame
1 month postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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