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Post operative atrial fibrillation following coronary surgery (POAF) is a common complication that can affect 10-50% of patients.
Intravenous magnesium, administered per-or post-operatively, reduces the incidence of POAF. However, the effect of preoperative magnesium loading on the incidence of POAF is not yet studied.
200 patients admitted for elective coronary surgery under Cardiopulmonary bypass will be included in this prospective randomized controlled trial.
Treatment group will receive preoperative oral magnesium and control group will receive placebo for 3 days before the planned coronary artery surgery.
The occurrence of POAF will be studied as a main outcome.
Post operative atrial fibrillation following coronary surgery (POAF) is a common complication that can affect 10-50% of patients. It is associated with many complications. POAF increases the postoperative length of stay and increases the cost of hospitalization.
Several studies and meta-analyzes have demonstrated the beneficial effect of intravenous magnesium (Mg), administered per-or post-operatively, in reducing the incidence of POAF. However, the effect of preoperative magnesium loading on the incidence of POAF is not yet studied.
The aim of this study is to study the effect of oral Mg, administered preoperatively, on the incidence of POAF.
Following IRB approval, 200 patients admitted for elective coronary surgery under Cardiopulmonary bypass will be included in this prospective randomized controlled trial. Patients will be allocated inn a 1: 1 ratio in 2 groups:
The anesthetic and surgical management protocols will be identical for both groups. The occurrence of POAF during the 7 postoperative days, the main outcome of the study, will be recorded, including the number of POAF episodes, their duration, recurrence, and the associated ventricular response rate. From a safety point, the occurrence of complications and the length of hospital stay will be noted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative oral Magnesium | Experimental | Magnesium sulfate 8 tablets (8 x 0.4 g) per day, PO, for the 3 days preceding the surgical intervention |
|
| Control | Placebo Comparator | Placebo oral tablet, for Magnesium Sulfate tablets, PO, for the 3 days preceding the surgical intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | Magnesium sulfate will be prescribed by the surgeon / Anesthesiologist and will be taken orally by the patient for the 3 days preceding the surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative atrial fibrillation | New onset of atrial fibrillation clinically or telemetry detected and confirmed by EKG | 7 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Ventricular response rate | Average ventricular rate during atrial fibrillation episodes | During the atrial fibrillation episodes |
| Recurrence of atrial fibrillation | Relapse of atrial fibrillation following the initial episode |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Time from surgery until discharge of the patient | ranges from 5 to 30 days |
| Stroke | New onset focal neurological deficit following coronary artery surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samia N Madi-Jebara | Saint-Joseph University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu de France | Beirut | 166830 | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35451469 | Derived | Tohme J, Sleilaty G, Jabbour K, Gergess A, Hayek G, Jebara V, Madi-Jebara S. Preoperative oral magnesium loading to prevent postoperative atrial fibrillation following coronary surgery: a prospective randomized controlled trial. Eur J Cardiothorac Surg. 2022 Oct 4;62(5):ezac269. doi: 10.1093/ejcts/ezac269. |
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IPD will be made available upon request from researchers who need to perform a meta analysis on the subject.
IPD will be sent directly to the requesting party
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Patients will be assigned to the 2 groups of treatment by blocks of 8. The randomization list will be computer-generated, with no factors for stratification. To reduce predictability of the random sequence, blocking will be made unavailable to those who assign interventions.
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treatment concealment will be managed by the central pharmacy of the hospital, which will dispense treatment according to the randomization plan.
|
| Placebo Oral Tablet | Drug | Placebo for Magnesium |
|
|
| 7 postoperative days |
| 30 postoperative days |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D019565 | Metals, Light |
| D008670 | Metals |
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