Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, Saline.
- Who it may be relevant to
- Registry conditions: New Onset, Atrial Fibrillation. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Prophylactic Role of Dexmedetomidine Drug in Reducing Early Postoperative New Onset Atrial Fibrillation After Mitral Valve Surgery - a Randomized Controlled Clinical Trial
Overview
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.
Interventions
- Drug Dexmedetomidine
Drug infusion to reduce postoperative atrial fibrillation - Other Saline
Normal saline infusion for placebo
Primary outcome measures
- Incidence rate of post operative new onset atrial fibrillation [Time frame: 72 hours postoperatively]
Secondary outcome measures (1)
- Any other cardiac tachy-arrhythmias as supra-ventricular or ventricular tachycardia. [Time frame: 72 hours postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Rezaei Y, Peighambari MM, Naghshbandi S, Samiei N, Ghavidel AA, Dehghani MR, Haghjoo M, Hosseini S. Postoperative Atrial Fibrillation Following Cardiac Surgery: From Pathogenesis to Potential Therapies. Am J Cardiovasc Drugs. 2020 Feb;20(1):19-49. doi: 10.1007/s40256-019-00365-1. PMID 31502217
- Greenberg JW, Lancaster TS, Schuessler RB, Melby SJ. Postoperative atrial fibrillation following cardiac surgery: a persistent complication. Eur J Cardiothorac Surg. 2017 Oct 1;52(4):665-672. doi: 10.1093/ejcts/ezx039. PMID 28369234
Identifiers
NCT: NCT07482540 · FMASU MD 51/2026