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Dexmedetomidine in Off Pump Coronary Artery Bypass Grafting

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
normal saline
Sponsored by
Suez Canal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    dex group

    control group

    Arm Description

    patients medicated with dexmedetomidine.

    patients took placebo normal saline.

    Outcomes

    Primary Outcome Measures

    left ventricular ejection fraction
    using transesophageal echocardiography, ejection fraction will be assessed by the ratio of stroke volume and end diastolic volume
    left ventricular fractional shorting
    using transesophageal echocardiography, fractional area change of the left ventricle will be calculated
    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').

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 8, 2022
    Last Updated
    October 11, 2022
    Sponsor
    Suez Canal University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05577871
    Brief Title
    Dexmedetomidine in Off Pump Coronary Artery Bypass Grafting
    Official Title
    Echocardiographic Evaluation of the Effect of Dexmedetomidine Infusion as an Adjuvant to General Anesthesia in Off-pump Coronary Artery Bypass Grafting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2022 (Anticipated)
    Primary Completion Date
    February 28, 2023 (Anticipated)
    Study Completion Date
    March 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Suez Canal University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    dex group
    Arm Type
    Active Comparator
    Arm Description
    patients medicated with dexmedetomidine.
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    patients took placebo normal saline.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Intervention Description
    infusion of dexmedetomidine during the off pump coronary artery bypass grafting surgery
    Intervention Type
    Drug
    Intervention Name(s)
    normal saline
    Intervention Description
    infusion of normal saline during the off pump coronary artery bypass grafting surgery
    Primary Outcome Measure Information:
    Title
    left ventricular ejection fraction
    Description
    using transesophageal echocardiography, ejection fraction will be assessed by the ratio of stroke volume and end diastolic volume
    Time Frame
    immediatly after sternal closure
    Title
    left ventricular fractional shorting
    Description
    using transesophageal echocardiography, fractional area change of the left ventricle will be calculated
    Time Frame
    immediatly after sternal closure
    Title
    left ventricular diastolic function
    Description
    using transesophageal echocardiography, diastolic function (filling ratio) will be assessed by the ratio between early transmitral flow (E) and mitral annular tissue velocity (E').
    Time Frame
    immediatly after sternal closure
    Secondary Outcome Measure Information:
    Title
    right ventricular systolic function
    Description
    right ventricular systolic function assessed by (fraction area change) as assessed using transesophageal echocardiography.
    Time Frame
    immediatly after sternal closure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abdelrhman Alshawadfy, MD
    Phone
    1091091620
    Ext
    +20
    Email
    abdelrhmanalshawadfy@gmail.com

    12. IPD Sharing Statement

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    Dexmedetomidine in Off Pump Coronary Artery Bypass Grafting

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