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
About this trial
This is an interventional treatment trial for Coronary Artery Disease
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.
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
NCT ID
NCT05577871
First Posted
October 8, 2022
Last Updated
October 11, 2022
Sponsor
Suez Canal University
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
Learn more about this trial
Dexmedetomidine in Off Pump Coronary Artery Bypass Grafting
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