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)

Evaluation of the effect of intravenous magnesium sulfate injection at doses of 2 and 4 grams on ventricular rate control in patients with acute atrial fibrillation.

Randomized, double-blind, placebo-controlled parallel-group phase 3 clinical trial on 90 patients. Block randomization method with block size of six using SPSS software was used for randomization.

Patients with acute atrial fibrillation presenting to the emergency department of Imam Khomeini Hospital in Ardabil city who meet the eligibility criteria will be enrolled in the study and will be randomly allocated to three groups using block randomization method with block size of six. This study will be performed as double-blind in which the patients, treating physician, and data analyst will not be informed about the type of intervention.

Inclusion criteria: Age over 18 years, acute atrial fibrillation, heart rate greater than 120 beats per minute, informed consent Exclusion criteria: Severe renal failure, severe heart failure, systolic blood pressure less than 90, bradycardia, hypersensitivity to magnesium sulfate, intravenous magnesium within past 24 hours

Intervention group 1: Intravenous injection of 50% magnesium sulfate at a dose of 2 grams, manufactured by Sinagen Pharmaceutical Company, as a single dose via slow injection over 5-10 minutes; Intervention group 2: Intravenous injection of 50% magnesium sulfate at a dose of 4 grams, manufactured by Sinagen Pharmaceutical Company, as a single dose via slow injection over 10-15 minutes; Control group: Intravenous injection of 100 mL placebo (0.9% normal saline, manufactured by Sinagen), single dose, slow injection over 10-15 minutes

Heart rate less than 90 beats per minute at 4 hours after injection; percentage of heart rate reduction at 4 hours after injection

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 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.

All data is potentially sharable once individuals are de-identified.

The data access period will begin 6 months after the publication of the final results.

The data will be available to researchers working in academic, scientific, and research institutions.

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.

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.

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.