NCT07482540

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Dec 2027

First Submitted

Initial submission to the registry

March 14, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

March 14, 2026

Last Update Submit

March 14, 2026

Conditions

New OnsetAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of post operative new onset atrial fibrillation

    72 hours postoperatively

Secondary Outcomes (1)

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

    72 hours postoperatively

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR
Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR
Other: Saline

Interventions

DexmedetomidineDRUG

Drug infusion to reduce postoperative atrial fibrillation

Dexmedetomidine
SalineOTHER

Normal saline infusion for placebo

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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: 31502217BACKGROUND

  • 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: 28369234BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

DexmedetomidineSodium Chloride

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2026

First Posted

March 19, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03