Dexmedetomidine in Off Pump Coronary Artery Bypass Grafting

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: normal saline

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt
    • Faculty of Medicine, Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dex group; patients medicated with dexmedetomidine.	Drug: Dexmedetomidine; infusion of dexmedetomidine during the off pump coronary artery bypass grafting surgery
Placebo Comparator: control group; patients took placebo normal saline.	Drug: normal saline; infusion of normal saline during the off pump coronary artery bypass grafting surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
left ventricular fractional shorting	using transesophageal echocardiography, fractional area change of the left ventricle will be calculated	immediatly after sternal closure
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
right ventricular systolic function	right ventricular systolic function assessed by (fraction area change) as assessed using transesophageal echocardiography.	immediatly after sternal closure

Collaborators and Investigators

• Sponsor: Suez Canal University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: October 8, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Azoles; Imidazoles; Crystalloid Solutions; Isotonic Solutions; Solutions; Dexmedetomidine; Saline Solution
• Other Study ID Numbers: Dex in CABG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No