Dexmedetomidine in Off Pump Coronary Artery Bypass Grafting

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease
• Interventions: Drug: Dexmedetomidine; Drug: normal saline

• Registration Number: NCT05577871
• Lead Sponsor: Suez Canal University

Brief 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.

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 Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-08
• Study First Submitted QC: 2022-10-11
• Last Update Submitted: 2022-10-11
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-13
• Study Start: 2022-11-01
• Primary Completion: 2023-02-28
• Study Completion: 2023-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dex group	Dexmedetomidine	patients medicated with dexmedetomidine.
control group	normal saline	patients took placebo normal saline.

Primary Outcome Measures

Name	Time	Method
left ventricular ejection fraction	immediatly after sternal closure	using transesophageal echocardiography, ejection fraction will be assessed by the ratio of stroke volume and end diastolic volume
left ventricular fractional shorting	immediatly after sternal closure	using transesophageal echocardiography, fractional area change of the left ventricle will be calculated
left ventricular diastolic function	immediatly after sternal closure	using transesophageal echocardiography, diastolic function (filling ratio) will be assessed by the ratio between early transmitral flow (E) and mitral annular tissue velocity (E').

Secondary Outcome Measures

Name	Time	Method
right ventricular systolic function	immediatly after sternal closure	right ventricular systolic function assessed by (fraction area change) as assessed using transesophageal echocardiography.