- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05577871
Dexmedetomidine in Off Pump Coronary Artery Bypass Grafting
Echocardiographic Evaluation of the Effect of Dexmedetomidine Infusion as an Adjuvant to General Anesthesia in Off-pump Coronary Artery Bypass Grafting
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ismailia, Egypt
- Faculty of Medicine, Suez Canal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: dex group
patients medicated with dexmedetomidine.
|
infusion of dexmedetomidine during the off pump coronary artery bypass grafting surgery
|
|
Placebo Comparator: control group
patients took placebo normal saline.
|
infusion of normal saline during the off pump coronary artery bypass grafting surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
immediatly after sternal closure
|
|
left ventricular fractional shorting
Time Frame: immediatly after sternal closure
|
using transesophageal echocardiography, fractional area change of the left ventricle will be calculated
|
immediatly after sternal closure
|
|
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').
|
immediatly after sternal closure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
right ventricular systolic function
Time Frame: immediatly after sternal closure
|
right ventricular systolic function assessed by (fraction area change) as assessed using transesophageal echocardiography.
|
immediatly after sternal closure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Heart Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Myocardial Ischemia
- Coronary Artery Disease
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Pharmaceutical Preparations
- Azoles
- Imidazoles
- Crystalloid Solutions
- Isotonic Solutions
- Solutions
- Dexmedetomidine
- Saline Solution
Other Study ID Numbers
- Dex in CABG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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