Comparison of Remimazolam With Propofol for Procedural Sedation in TEE

Patients often undergo procedures outside of traditional operating rooms. With continued advances in minimally invasive and percutaneous techniques, recent trends demonstrate that sicker and increasingly unstable patients are routinely undergoing progressively more complex procedures in this space. Many of these procedures and patients necessitate varying levels of sedation due to pain, anxiety, and optimized procedural-conditions, among other reasons. Commonly utilized medications include benzodiazepines (like midazolam), opioids (like fentanyl), sedative-hypnotics (like propofol), and other adjuncts (such as dexmedetomidine and diphenhydramine).

Previous studies have shown that each of these agents has significant drawbacks that limit its utility. Propofol, while being fast in onset and offset, is limited by the lack of available reversal agent, the high liability for significant cardiac and/or respiratory depression, and the costly requirement of an anesthesia team for administration. Midazolam does not suffer from any of the shortcomings of propofol, but it has a much slower onset and offset, limiting both procedural and PACU timeliness/throughput and imparting prolonged CNS effects on patients (especially older patients) for hours to days after administration. Most adjuncts similarly have very slow onset and offset profiles, and they necessitate concomitant administration of other agents to achieve suitable procedural conditions.

Recently, a novel benzodiazepine (remimazolam) received FDA approval for procedural sedation for procedures lasting no more than thirty minutes. This agent combines the best qualities of propofol and midazolam while avoiding the downfalls of each. Specifically, remimazolam appears to maintain hemodynamic stability while rapidly allowing for ideal sedation conditions without lingering effects. These qualities make it a particularly good choice for procedural sedation and monitored anesthesia care for sicker, more tenuous patients. Despite FDA approval, adoption of this agent remains limited at present, likely due in part to cost as well as limited provider (anesthesiologist & proceduralist) experience with the agent. Nonetheless, it appears that using remimazolam for procedural sedation for our sickest patients with the most tenuous hemodynamic status may be a safer alternative to the current standard of care.

In attempt to answer this question, the investigators wish to compare the current practice of using propofol for sedation with the sedation achieved using remimazolam at recommended doses in patients scheduled to undergo transesophageal echocardiography. This patient population was intentionally chosen as it represents the sickest and most hemodynamically tenuous group of patients we sedate for procedures.

The significance of the study is that remimazolam, based on published experiences in other procedures, should produce robust sedation in subjects undergoing transesophageal echocardiogram studies with significantly less hemodynamic perturbation (hypotension) than results from propofol as part of current practice. If this observation is confirmed in this population, then it is likely that a change in the current practice would occur to improve patient safety.