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IRCT20260509069313N1 IRCT 2026-06-22 Ardabil University of Medical Sciences Effect of magnesium sulfate in atrial fibrillation Evaluation of the Effects of Magnesium Sulfate Injection at Doses of 2 and 4 Grams on Ventricular Response Control in Patients with Atrial Fibrillation (AF) 2026-05-22 anticipated 90 Complete https://irct.ir/trial/89978 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is block randomization with block sizes of six. Since there are 3 study groups, each block of 6 patients is randomly allocated such that 2 patients are assigned to each group per block. The unit of randomization is individual. Stratified randomization is performed based on age (less than 65 years and 65 years or older) and gender. The randomization tool is SPSS statistical software version 26 using the random number generation function. The random sequence is generated by a statistician who has no role in patient treatment. Allocation of patients to intervention groups is performed using sealed, opaque, sequentially numbered envelopes. The envelopes are opened by a person independent of the principal investigator, Blinding description: Blinding Method: This study was conducted as a double-blind randomized clinical trial. The blinding process was implemented as follows: Blinding of Participants: To ensure patients remained blinded, the interventions (different doses of Magnesium Sulfate or Normal Saline as a placebo) were prepared in 50cc syringes that were identical in appearance, color, and volume. Therefore, the participants were unaware of the specific treatment they received. Blinding of Investigators and Outcome Assessors: The random allocation sequence was kept in sealed envelopes. A designated nurse, who was not involved in outcome assessment or data recording, opened the envelopes and prepared the syringes according to the assigned codes. The principal investigator and the person responsible for measuring heart rate and recording clinical outcomes remained blinded to the group assignments and the contents of the syringes throughout the data collection period. 3 Atrial Fibrillation. Intervention 1: Intervention group 1: Intravenous injection of magnesium sulfate at a dose of 2 grams. The medication is magnesium sulfate with concentration of 50% (500 mg/mL) manufactured by Sinagen Pharmaceutical Company. The dose is 2 grams as a single dose. The route of administration is slow intravenous injection over 5-10 minutes. Intervention 2: Intervention group 2: Intravenous injection of magnesium sulfate at a dose of 4 grams. The medication is magnesium sulfate with concentration of 50% (500 mg/mL) manufactured by Sinagen Pharmaceutical Company. The dose is 4 grams as a single dose. The route of administration is slow intravenous injection over 10-15 minutes. Intervention 3: Control group: Intravenous injection of placebo (100 mL of 0.9% normal saline - sodium chloride 0.9%) manufactured by Sinagen Pharmaceutical Company. The dose is 100 mL as a single dose. The route of administration is slow intravenous injection over 10-15 minutes. Yes - There is a plan to make this available What will be shared: All data is potentially sharable once individuals are de-identified. When: The data access period will begin 6 months after the publication of the final results. To whom: The data will be available to researchers working in academic, scientific, and research institutions. Conditions: The data will be shared for the purpose of meta-analyses and secondary analyses. Access is subject to the submission and approval of a formal research proposal by the corresponding author and the signing of a data use agreement to ensure confidentiality. Where to obtain: Requests for access to data should be sent to the corresponding author via email. Data will be available to researchers in academic institutions starting 6 months after publication for the purpose of secondary analysis or meta-analysis, provided that a formal research proposal is submitted and approved. How to obtain: The process for requesting data: Applicants must submit a formal request, including a research proposal and the objectives of the analysis, to the corresponding author's email. The request will be reviewed by the research team. Upon approval, a Non-Disclosure Agreement (NDA) will be sent to the applicant. After the signed agreement is returned, the de-identified data will be shared via email or a secure file-sharing platform. Comments:
public Zahra Amirajam
Administrative Complex of Ardabil University of Medical Sciences, University Ave., Ardabil, Iran.
Ardabil Iran (Islamic Republic of) ۵۶۱۸۹۸۵۹۹۱ +98 45 3353 4790 zahra.amirajam@arums.ac.ir Ardabil University of Medical Sciences scientific Zahra Amirajam
Administrative Complex of Ardabil University of Medical Sciences, University Ave., Ardabil, Iran.
Ardabil Iran (Islamic Republic of) ۵۶۱۸۹۸۵۹۹۱ +98 45 3353 4790 zahra.amirajam@arums.ac.ir Ardabil University of Medical Sciences Iran (Islamic Republic of) Adult patients (over 18 years old) with acute atrial fibrillation and a heart rate greater than 120 beats per minute (bpm) Willingness to participate in the study and informed consent 18 years no limit Both Severe renal failure (GFR less than 30) Severe heart failure (Class IV based on NYHA) Systolic blood pressure less than 90 mmHg Bradycardia (heart rate less than 50 beats per minute) Known hypersensitivity to magnesium sulfate Intravenous magnesium administration within the past 24 hours Serum magnesium level greater than 2.5 mg/dL I48 Atrial fibrillation and flutter Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Intravenous injection of magnesium sulfate at a dose of 2 grams. The medication is magnesium sulfate with concentration of 50% (500 mg/mL) manufactured by Sinagen Pharmaceutical Company. The dose is 2 grams as a single dose. The route of administration is slow intravenous injection over 5-10 minutes. Intervention group 2: Intravenous injection of magnesium sulfate at a dose of 4 grams. The medication is magnesium sulfate with concentration of 50% (500 mg/mL) manufactured by Sinagen Pharmaceutical Company. The dose is 4 grams as a single dose. The route of administration is slow intravenous injection over 10-15 minutes. Control group: Intravenous injection of placebo (100 mL of 0.9% normal saline - sodium chloride 0.9%) manufactured by Sinagen Pharmaceutical Company. The dose is 100 mL as a single dose. The route of administration is slow intravenous injection over 10-15 minutes. Percentage of patients whose heart rate reaches less than 90 beats per minute at 4 hours after injection. Timepoint: Before intervention, 4 hours after injection. Method of measurement: Using cardiac monitoring and electrocardiogram recording. Percentage of heart rate reduction from baseline at 4 hours after injection. Timepoint: Before intervention, 4 hours after injection. Method of measurement: Calculation of percentage of heart rate reduction compared to baseline using cardiac monitoring. Ardabil University of Medical Sciences Approved 2026-04-12 Research Ethics Committees of Ardabil University of Medical Sciences Administrative Complex of Ardabil University of Medical Sciences, University Ave., Ardabil, Iran. Ardabil Ardabil Iran (Islamic Republic of)