Preoperative Oral Magnesium to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS)
Condition: Atrial Fibrillation; Coronary Artery Disease; Surgery--Complications
MeSH terms: Atrial Fibrillation; Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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:

        -  Treatment group will receive preoperatively 8 tablets of Mg (3.2 g) per day, at day
           (-3), day (-2), and day (-1) before the day of planned coronary artery surgery.

        -  Control group will receive 8 tablets of placebo daily,at day (-3), day (-2), and day
           (-1) before the day of planned coronary artery surgery.

      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.
    

Intervention name(s): Magnesium Sulfate; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Magnesium sulfate will be prescribed by the surgeon / Anesthesiologist and will be taken orally by the patient for the 3 days preceding the surgery; Placebo for Magnesium
Other intervention name(s): Magnesium; Placebo
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Coronary artery surgery; oral magnesium; atrial fibrillation; Randomized controlled trial