Coronary Artery DiseaseNCT05577871
Dexmedetomidine in Off Pump Coronary Artery Bypass Grafting
A study testing Dexmedetomidine and normal saline in people with Coronary Artery Disease, run by Suez Canal University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Dexmedetomidine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Echocardiographic Evaluation of the Effect of Dexmedetomidine Infusion as an Adjuvant to General Anesthesia in Off-pump Coronary Artery Bypass Grafting
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.
Read the 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
- Being tested
- Dexmedetomidine, normal saline
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
infusion of dexmedetomidine during the off pump coronary artery bypass grafting surgery
normal salineDrug
infusion of normal saline during the off pump coronary artery bypass grafting surgery
| Study group | Role | What they receive |
|---|---|---|
| dex group | Active comparator | patients medicated with dexmedetomidine. Receives: Drug: Dexmedetomidine |
| control group | Placebo comparator | patients took placebo normal saline. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular ejection fraction
using transesophageal echocardiography, ejection fraction will be assessed by the ratio of stroke volume and end diastolic volume
Measured: immediatly after sternal closure
left ventricular fractional shorting
using transesophageal echocardiography, fractional area change of the left ventricle will be calculated
Measured: 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').
Measured: immediatly after sternal closure
Secondary outcomes (1)
right ventricular systolic function
right ventricular systolic function assessed by (fraction area change) as assessed using transesophageal echocardiography.
Measured: immediatly after sternal closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Nov 2022
- Primary completion28 Feb 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577871
- Sponsor's protocol ID
- Dex in CABG
- Status last verified
- May 2026
- First submitted
- 8 Oct 2022
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Evaluation of the Effect of Dexmedetomidine Infusion as an Adjuvant to General Anesthesia in Off-pump Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT05577871
- Acronym / sponsor ID
- Dex in CABG
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dex group | Active comparator | Drug: Dexmedetomidinepatients medicated with dexmedetomidine. |
| control group | Placebo comparator | Drug: normal salinepatients took placebo normal saline. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidineinfusion of dexmedetomidine during the off pump coronary artery bypass grafting surgery | Drug | dex group |
| normal salineinfusion of normal saline during the off pump coronary artery bypass grafting surgery | Drug | control group |
Primary outcome
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
left ventricular fractional shorting
Time frame: immediatly after sternal closure
using transesophageal echocardiography, fractional area change of the left ventricle will be calculated
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').
1 secondary outcome
right ventricular systolic function
Time frame: immediatly after sternal closure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and normal saline in people with Coronary Artery Disease, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular ejection fraction (time frame: immediatly after sternal closure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.