New OnsetNCT07482540
Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery
A study testing Dexmedetomidine and Saline in people with New Onset and Atrial Fibrillation, run by Ain Shams University.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- New Onset, Atrial Fibrillation
- What is being tested?
- Dexmedetomidine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 21 years or older. American Society of Anesthesiologists (ASA) physical status II-III. Patients able to provide written informed consent.
Who cannot join
- 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
About this study
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
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.
- Conditions
- New Onset, Atrial Fibrillation
- Being tested
- Dexmedetomidine, Saline
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Drug infusion to reduce postoperative atrial fibrillation
SalineOther
Normal saline infusion for placebo
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Not described Receives: Drug: Dexmedetomidine |
| Placebo | Placebo comparator | Not described Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of post operative new onset atrial fibrillation
Measured: 72 hours postoperatively
Secondary outcomes (1)
Any other cardiac tachy-arrhythmias as supra-ventricular or ventricular tachycardia.
Measured: 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for New OnsetStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482540
- Sponsor's protocol ID
- FMASU MD 51/2026
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31502217Greenberg 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.
PubMed 28369234
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07482540
- Acronym / sponsor ID
- FMASU MD 51/2026
- Conditions
- New Onset, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine |
| Placebo | Placebo comparator | Other: Saline |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged 21 years or older. American Society of Anesthesiologists (ASA) physical status II-III. Patients able to provide written informed consent.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineDrug infusion to reduce postoperative atrial fibrillation | Drug | Dexmedetomidine |
| SalineNormal saline infusion for placebo | Other | Placebo |
Primary outcome
Incidence rate of post operative new onset atrial fibrillation
Time frame: 72 hours postoperatively
1 secondary outcome
Any other cardiac tachy-arrhythmias as supra-ventricular or ventricular tachycardia.
Time frame: 72 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 31502217Rezaei 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.
- Background: PubMed 28369234Greenberg 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Saline in people with New Onset and Atrial Fibrillation, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of post operative new onset atrial fibrillation (time frame: 72 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07482540, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.