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Completed

NCT Number: NCT05577871

Dexmedetomidine 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.

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Suez Canal University

Ismailia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

infusion of dexmedetomidine during the off pump coronary artery bypass grafting surgery

normal saline

Drug

infusion of normal saline during the off pump coronary artery bypass grafting surgery

Primary outcomes

  1. left ventricular ejection fraction

    Time frame: immediatly after sternal closure

    using transesophageal echocardiography, ejection fraction will be assessed by the ratio of stroke volume and end diastolic volume

  2. left ventricular fractional shorting

    Time frame: immediatly after sternal closure

    using transesophageal echocardiography, fractional area change of the left ventricle will be calculated

  3. left ventricular diastolic function

    Time frame: 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 outcomes

  1. right ventricular systolic function

    Time frame: immediatly after sternal closure

    right ventricular systolic function assessed by (fraction area change) as assessed using transesophageal echocardiography.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Oct 13, 2022
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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