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Efficacy of intraoperative low dose intravenous amiodarone in pharmacologic cardioversion in patients with preoperative atrial fibrillation presenting for mitral valve replacement surgery Randomized control trial

Efficacy of intraoperative low dose intravenous amiodarone in pharmacologic cardioversion in patients with preoperative atrial fibrillation presenting for mitral valve replacement surgery Randomized control trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202201680255620
Enrollment
90
Registered
2022-01-28
Start date
2022-01-07
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Circulatory System Cardiology Anaesthesia

Interventions

Low dose amiodarone
Control

Sponsors

faculty of medicine ain shams unversity
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ·       All elective isolated cases undergoing mitral valve replacement with a preoperative atrial fibrillation rhythm > 100/min as evidenced by ECG. ·       ASA physical status 2-5 ·       Sex (males and females) ·       Age 18-70 years.

Exclusion criteria

Exclusion criteria: ·       Patients are refusing to participate in the study. ·       Below 18 or above 60 years. ·       Emergency and urgent patients. ·       Patients are undergoing combined valve or CABG surgery. ·       Patients with previous PCI. ·       Patients with rhythm defects evidenced by ECG. ·       Patient on amiodarone or other rhythm modifying drugs, e.g., Digoxin, Beta Blockers, CCBs, etc. ·       Patients with preoperative lung conditions or O2 saturation below 90%. ·       Patients with preoperative abnormal hepatic profiles identified by double average values of ALT/AST or bilirubin or hypoalbuminemia ·       Patients with preoperative renal impairment identified by serum creatinine more than 1.7 mg/dL ·       Abnormal thyroid profile or any history suggestive of thyroid diseases. ·       Diabetic patients, as the study, include Dextrose 5% based medication.

Design outcomes

Primary

MeasureTime frame
Observe persistence of AF at the end of surgery and document rhythm before transfer to ICU.

Secondary

MeasureTime frame
Initial repercussion rhythm shortly after declamping will be recorded, whether ventricular fibrillation, normal sinus rhythm, or AF ;§  Heart rate and rhythm 10, 30, 60 minutes after de-clamping. ;§  Recurrence of AF during the hospital stay. ;Need for epicardial pacing.

Countries

Egypt

Contacts

Public ContactFarouk Kamal

lecture of anesthesia faculty of medicine ain shams university

dr.faroukkamal@med.asu.edu.eg+201066241179

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026