Dexmedetomidine in Off Pump Coronary Artery Bypass Grafting

NCT05577871 | Unknown

• 1 other identifier: Dex in CABG
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• right ventricular systolic function

  immediatly after sternal closure

Study Arms (2)

dex group

ACTIVE COMPARATOR

patients medicated with dexmedetomidine.

Drug: Dexmedetomidine

control group

PLACEBO COMPARATOR

patients took placebo normal saline.

Drug: normal saline

Interventions

Dexmedetomidine DRUG

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

dex group

normal saline DRUG

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

control group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Abdelrhman Alshawadfy, MD

CONTACT

1091091620; abdelrhmanalshawadfy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and intensive care

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: October 13, 2022
• Study Start: November 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 30, 2023
• Last Updated: October 13, 2022

Record last verified: 2022-10