INTRODUCTION: The study focuses on comparing the effectiveness of oral Bisoprolol, a beta-1 adrenergic receptor blocker, against intravenous Diltiazem, a calcium channel blocker, in treating rapid atrial fibrillation or flutter with rapid ventricular response in an emergency setting. This research aims to fill the gap in empirical evidence regarding the use of oral Bisoprolol for these conditions, potentially offering a convenient, evidence-based alternative for patient management in emergency departments where established protocols are lacking.
METHOD: This study is a randomized controlled trial targeting patients who present to the emergency room with symptomatic atrial fibrillation or flutter and rapid ventricular response requiring intervention. Participants will be split into two groups and undergo continuous monitoring of vital signs and regular electrocardiograms to ensure safety and document any adverse effects. The primary focus is on patient safety while evaluating the efficacy of the treatments.
AIM: Evaluate the efficacy and safety of oral bisoprolol in treating atrial fibrillation or atrial flutter with rapid ventricular response in an emergency department setting.
PRIMARY OJECTIVES: The primary efficacy outcome will be evaluated by achieving a HR\<110 beats per minute or a decrease ≥20% of baseline HR at 60 minutes. The primary safety outcome measures are HR \< 60 bpm and SBP \< 95 mm Hg.
SECONDARY OBJECTIVES: The use of Rescue medication, proportion of patients who required hospitalization, worsening of heart failure or pulmonary oedema, side effect of medication ( dizziness, headaches, gastrointestinal symptoms)
PATEINT POPULATION: Adults (18 and older) presenting to the emergency department at Sultan Qaboos University Hospital with symptomatic atrial fibrillation or atrial flutter with rapid ventricular response requiring treatment.
INTERVENTION: A single oral dose of 5 mg Bisoprolol (maximum dose of 5 mg) or a single intravenous dose of Diltiazem at 0.25 mg/kg (to a maximum dose of 30 mg).
CLINICAL MEASURMENT: Heart rate recorded every 15 minutes up to the 90-minute mark, with a 12-lead ECG performed every 30 minutes.
OUTCOME: For therapy to be considered effective, patients must achieve a ventricular rate ≤110/min or experience a drop-in ventricular rate of at least 20% at 60 minutes.
≥ 18 years old.
Atrial fibrillation (RVR) or Atrial flutter on electrocardiogram.
Heart rate >120 beats/min
Stable patient with stable vital signs (Defined as having a SBP >110 mmHg, oxygen saturation > 94% on room air or with a simple face mask, a respiratory rate within normal limits, being conscious and oriented, and not having any concurrent life-threatening conditions such as myocardial infarction (MI) or Class IV heart failure).
Acute myocardial infarction.
Known congenital and acquired valvular defects.
Pre-excitation syndromes.
Ventricular rate > 220beats/min.
Parallel
Oral Bisoprolol
DrugParticipants in this group will receive a single oral dose of Bisoprolol, set at a dosage of 5 mg, with a maximum dose limit of 5 mg.
Intravenous Diltiazem
DrugParticipants in this group will be administered a single intravenous dose of diltiazem at a dosage of 0.25 mg/kg, with a maximum dose capped at 30 mg.
Efficacy Outcome Evaluated by Achieving the Target Heart Rate Reduction
The primary efficacy outcome evaluated by achieving a HR\<110 beats per minute or a decrease ≥20% of baseline HR at 60 minutes
Safety Outcome Evaluated by the Presence of serious adverse event
The primary safety outcome measures were HR \< 60 bpm and SBP \< 95 mm Hg
The use of Rescue medication
Rescue rate control defined as the administration of a supplementary rate control medication after 60 minutes of the initial dose of the interventional drug
Proportion of patients who required hospitalization
percentage of individuals within a study who need to be admitted to a hospital for treatment, observation, or further medical care
ED revisit
Number of patient who will revisit ED with symptomatic AF after stabilization and discharge
Number of Participants Experiencing Treatment-Related Adverse Events
Any patient experience ( Dizziness, headaches, gastrointestinal symptoms , Worsening of heart failure or pulmonary edema )
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