Dexmedetomidine in Off Pump Coronary Artery Bypass Grafting

Coronary Artery Disease Clinical Trial

Official title:

Echocardiographic Evaluation of the Effect of Dexmedetomidine Infusion as an Adjuvant to General Anesthesia in Off-pump Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05577871
• Other study ID #: Dex in CABG
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: October 2022
• Source: Suez Canal University
• Contact: Abdelrhman Alshawadfy, MD
• Phone: 1091091620
• Email: abdelrhmanalshawadfy[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the study will assess the impact of intraoperative dexmedetomidine infusion on myocardial performance by investigating the left ventricular (LV) systolic and diastolic function and right ventricular (RV) fraction area change (which reflect RV systolic function) using two-dimensional trans-esophageal echocardiography (TEE) in patients undergoing elective first-time isolated off-pump coronary artery bypass (OPCAB) grafting. LV Systolic function will be measured by the TEE via the fractional area change, fraction shortening, and ejection fraction.

Description:

Off pump coronary revascularization is an old technique performed first in St Petersburg in 1964, Off pump coronary artery surgery has been developed following two different approaches. Minimally invasive direct-access coronary artery bypass (MIDCAB) that consists of anastomosing the left internal mammary artery to the left anterior descending coronary artery through small anterior left thoracotomy, The second approach is multi-vessel grafting without CPB performed through standard median sternotomy. Dexmedetomidine (Dex), a highly selective α2-adrenergic receptor agonist, is widely used for sedation and analgesia in the ICU or as an anesthetic adjuvant.

This study will be a prospective comparative controlled randomized double blinded clinical trial on 36 patients divided into control ,and dexmedetomidine group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: March 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients undergoing elective first-time off-pump isolated coronary artery bypass graft (OPCAB) surgery

• Patients with good ventricular functions.

• Patients with normal levels of cardiac troponin I and myocardial enzymes

• Patients of Body Mass Index (BMI) more than 20 and less than 34.

Exclusion Criteria:

• Severe functional liver or kidney disease.

• Diagnosed HF (NYHA class >3).

• Arrhythmia or received treatment with anti-arrhythmic drugs.

• Severe bradycardia (HR < 45 bpm) and AV block.

• Pathologic esophageal lesion (esophageal stricture or varix )

• Pregnancy.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• Dexmedetomidine
infusion of dexmedetomidine during the off pump coronary artery bypass grafting surgery
• normal saline
infusion of normal saline during the off pump coronary artery bypass grafting surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricular ejection fraction	using transesophageal echocardiography, ejection fraction will be assessed by the ratio of stroke volume and end diastolic volume	immediatly after sternal closure
Primary	left ventricular fractional shorting	using transesophageal echocardiography, fractional area change of the left ventricle will be calculated	immediatly after sternal closure
Primary	left ventricular diastolic function	using transesophageal echocardiography, diastolic function (filling ratio) will be assessed by the ratio between early transmitral flow (E) and mitral annular tissue velocity (E').	immediatly after sternal closure
Secondary	right ventricular systolic function	right ventricular systolic function assessed by (fraction area change) as assessed using transesophageal echocardiography.	immediatly after sternal closure