Dexmedetomidine in Off Pump Coronary Artery Bypass Grafting

NCT ID: NCT05577871

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-03-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

dex group

patients medicated with dexmedetomidine.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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

control group

patients took placebo normal saline.

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

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

Interventions

Dexmedetomidine

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

Intervention Type: DRUG

normal saline

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrhman Alshawadfy

Lecturer of anesthesia and intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Abdelrhman Alshawadfy, MD

Role: CONTACT

abdelrhmanalshawadfy@gmail.com

1091091620 ext. +20

Other Identifiers

Dex in CABG

Identifier Type: -

Identifier Source: org_study_id