Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting

Dexmedetomidine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05640453
• Other study ID #: 35912/10/22
• Status: Recruiting
• Phase: Phase 4
• Start date: December 15, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: April 2023
• Source: Tanta University
• Contact: Islam Morsy, MD
• Phone: 00201093387374
• Email: eslam.morsy[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting
• Delirium
• Dexmedetomidine
• Pregabalin

Intervention

Drug:
• Pregabalin
Patients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube.
• Dexmedetomidine
Patients will receive a bolus dose of 0.4 µg/kg dexmedetomidine (over a period of 10 to 20 min)

Locations

Country	Name	City	State
Egypt	Islam Morsy	Tanta	El-Gharbia Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

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