Cardiologist-Administered Midazolam vs. Anaesthesiologist-Assisted Propofol Sedation For Transoesophageal Echocardiography-Guided Cardioversion of Atrial Fibrillation

Condition(s) studied

Investigational drug(s) / intervention(s)

One-step cardiologist-only midazolam sedation: TOE-guided DCC performed under continuous cardiologist-administered midazolam sedation, without anaesthesiologist involvement. Midazolam is administered intravenously at the discretion of the treating cardiologist. Non-binding dosing guidance is provided to support clinical practice, but dosing may be individualised as clinically indicated. * For the TOE phase, suggested dosing includes an initial IV dose of 1.25-5.0 mg, with repeat doses of 1.25-2.5 mg as needed, and a suggested maximum cumulative dose of 20 mg. * For the DCC phase, suggested dosing includes an initial IV dose of 2.5-7.5 mg, with repeat doses of 2.5 mg as needed. A suggested maximum cumulative dose of 25 mg applies, including doses administered during the TOE phase. Flumazenil reversal is recommended.

Two-step anaesthesiologist-assisted propofol sedation: TOE performed under cardiologist-administered sedation followed by a wake-up period and subsequent DCC performed under propofol sedation administered by an anaesthesiologist. Sedation for TOE and DCC is administered following established local guidelines.

Study summary

Irregular heart rhythms, known as atrial fibrillation or atrial flutter, are common conditions that can increase the risk of stroke and heart failure. A standard treatment to restore a normal rhythm is a controlled electric shock, known as cardioversion. However, if the irregular rhythm has lasted more than 24 hours, if the duration is uncertain, and if the patient has not been on blood-thinning medication for at least three weeks, doctors must first check for blood clots in the heart. This is done using a special ultrasound scan of the heart through the food pipe.

Both the scan and the electric shock treatment require sedation to make the patient relaxed or asleep. The scan uses mild sedation from a cardiologist, while the shock needs a stronger sedative given by an anaesthesiologist. But needing this extra doctor can cause delays, so patients often wait longer for treatment and to go home.

This study will test whether a cardiologist can safely handle both steps using a sedative called midazolam. This study will include 220 adults at multiple hospitals in Denmark and compare this new approach to standard care. Researchers will track how quickly patients go home, how well the treatment works, any serious side effects, what patients think about the experience, and how much money can be saved.

If proven safe and effective, this new method could reduce treatment delays, shorten hospital stays, and lower healthcare costs-ultimately improving care for patients and making the healthcare system more efficient.

Eligibility

Primary outcome measure(s)

• Time-to-discharge — Day 1.
  The primary outcome is time-to-discharge after TOE, with the corresponding endpoint operationalised as the mean number of minutes from randomisation (post-TOE) to formal hospital discharge. This outcome is designed to capture the impact on the healthcare system by serving as a proxy for resource use, where shorter time-to-discharge may reduce bed occupancy, staff workload, and overall hospital costs.

Trial sites (2)

More Gødstrup Hospital trials in Denmark

Other trials for the same condition