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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07482540
Enrollment
140
Registered
2026-03-19
Start date
2026-06-01
Completion date
2027-12-31
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, New Onset

Brief summary

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

DRUGDexmedetomidine

Drug infusion to reduce postoperative atrial fibrillation

OTHERSaline

Normal saline infusion for placebo

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence rate of post operative new onset atrial fibrillation72 hours postoperatively

Secondary

MeasureTime frame
Any other cardiac tachy-arrhythmias as supra-ventricular or ventricular tachycardia.72 hours postoperatively

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026