Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting

Phase 4

Recruiting

• Conditions: Pregabalin; Delirium Treatment; Coronary Artery Bypass Grafting; Dexmedetomidine
• Interventions: Drug: Pregabalin; Drug: Dexmedetomidine

• Registration Number: NCT05640453
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-12-06
• Study First Posted: 2022-12-07
• Study Start: 2022-12-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-15
• Last Update Posted: 2023-04-18
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin group	Pregabalin	Patients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube.
Dexmedetomidine group	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Percent of delirium treatment	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 Outcome Measures

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

Trial Locations

Locations (1)

Islam Morsy; 🇪🇬 Tanta, El-Gharbia Governorate, Egypt