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NCT Number: NCT07482540

Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery

Recently, dexmedetomidine has been suggested as an alternative agent for sedation in tachyarrhythmias due to its antiarrhythmic properties through decreased catecholamine release, prolonged refractory period, and increased vagal tone. In addition, dexmedetomidine is a highly selective agonist that does not interact with the gamma-aminobutyric acid (GABA) receptors. Thus, its analgesic properties are opioid sparing, which is unique among traditional ICU sedatives and avoids the issue of respiratory depression with over-sedation.

Our aim: To evaluate the potential prophylactic effect of perioperative dexmedetomidine in reducing the incidence of early postoperative new onset atrial fibrillation following mitral valve surgery.

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Key information

Conditions

New Onset Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients aged 21 years or older. American Society of Anesthesiologists (ASA) physical status II-III. Patients able to provide written informed consent.

Exclusion criteria

History of cardiac arrhythmias: atrial fibrillation or any other clinically significant cardiac tachyarrhythmias.

Any degree of atrioventricular block or presence of permanent pacemaker and bradycardia (heart rate < 60 beats/min) or hemodynamic instability.

Emergency mitral valve surgery. Left ventricular dysfunction (ejection fraction < 55%) Ischemic heart disease patients. Severe hepatic or renal impairment. Known hypersensitivity or contraindication to dexmedetomidine. Chronic use of class I or class III anti-arrhythmic drugs

Treatment and study plan

Dexmedetomidine

Drug

Drug infusion to reduce postoperative atrial fibrillation

Saline

Other

Normal saline infusion for placebo

Primary outcomes

  1. Incidence rate of post operative new onset atrial fibrillation

    Time frame: 72 hours postoperatively

Secondary outcomes

  1. Any other cardiac tachy-arrhythmias as supra-ventricular or ventricular tachycardia.

    Time frame: 72 hours postoperatively

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Prophylactic Role of Dexmedetomidine Drug in Reducing Early Postoperative New Onset Atrial Fibrillation After Mitral Valve Surgery - a Randomized Controlled Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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