Remimazolam vs Propofol for Anesthesia

Overseen By Justin Routman

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Alabama at Birmingham

Disqualifiers: Emergent TEE, ICU, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new sedative, remimazolam, compares to the commonly used sedative, propofol, for patients undergoing transesophageal echocardiography (TEE). Researchers aim to determine if remimazolam offers benefits such as better heart stability or faster recovery. Eligible participants are those scheduled for a non-emergency TEE at the UAB Heart and Vascular Center. This study may suit patients preparing for this specific heart test who are not undergoing other procedures. As a Phase 1 trial, this research focuses on understanding how remimazolam works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that remimazolam, a new sedative, is generally safer for the heart and lungs than the commonly used propofol. One study found that remimazolam caused fewer issues like low blood pressure and slow heart rate compared to propofol. Another study indicated that remimazolam also had a lower risk of causing breathing problems.

Most patients tolerate remimazolam well, and serious breathing issues are rare. However, results are mixed regarding whether remimazolam might cause nausea after surgery, and data on this is limited. The FDA has already approved remimazolam for other uses, suggesting it is generally safe.

Overall, remimazolam is considered quite safe, with fewer common side effects than some other sedatives. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for anesthesia, like the standard propofol, work by enhancing the activity of certain neurotransmitters in the brain to induce sedation. However, remimazolam is unique because it is a new type of benzodiazepine that acts rapidly and has a shorter duration of action. Researchers are excited about remimazolam because it offers more control over sedation levels and potentially fewer side effects due to its fast onset and quick recovery time. This could mean a smoother experience for patients undergoing procedures like transesophageal echocardiograms (TEEs).

What evidence suggests that this trial's treatments could be effective for anesthesia during TEE procedures?

This trial will compare Remimazolam with Propofol for anesthesia. Research has shown that Remimazolam, which participants in this trial may receive, is a promising option for sedation, performing as well as Propofol. It has proven more effective than similar drugs in various situations, such as during endoscopy and in intensive care. Importantly, Remimazolam reduces the risk of low oxygen levels in the blood, a common concern with sedation. Both patients and healthcare providers generally express satisfaction with Remimazolam, and serious breathing problems occur rarely. These findings suggest that Remimazolam is a safe and effective choice for sedation, especially for older patients. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

Adults aged 18 or older scheduled for elective/non-emergent transesophageal echocardiography (TEE) at the UAB Heart and Vascular Center TEE Lab can participate in this trial.

Inclusion Criteria

I am 18 or older and scheduled for a planned heart ultrasound at UAB.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either remimazolam or propofol for sedation during the TEE procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after sedation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Propofol
• Remimazolam

Trial Overview The study compares two sedatives: remimazolam, a new FDA-approved drug, versus propofol, which is currently used. It aims to see if remimazolam improves patient hemodynamics and procedural efficiency during TEE.

How Is the Trial Designed?

Group I: Remimazolam Experimental Treatment 1 Intervention

2.5-5 mg IV remimazolam will be administered no more frequently than every 2 minutes for the duration of the TEE procedure.

Group II: Propofol Active Control 1 Intervention

Standard-of-care IV propofol administration will be administered at the discretion of the anesthesia team caring for the patient for the duration of the TEE procedure

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40503766/

a systematic review and meta-analysis of randomized ... Conclusion: Remimazolam and propofol achieved comparable success rates for sedation and general anesthesia. Remimazolam reduced hypoxemia risk ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S295739122500035X

Remimazolam in anesthesia and sedation: A narrative review Clinical evidence shows that remimazolam is more effective than similar drugs in scenarios such as gastrointestinal endoscopy, operating rooms, and ICUs.

3. nature.com nature.com/articles/s41598-024-58294-2

Comparison of efficacy and safety of equivalent doses ... After validation with a larger sample size in the second step, our results showed that the effective rate of remimazolam was 78% and that of ...

4. sjtrem.biomedcentral.com sjtrem.biomedcentral.com/articles/10.1186/s13049-025-01402-6

a prospective study of effectiveness and patient satisfaction Results · Remimazolam was safe to use, and severe respiratory adverse effects were rare · Patient and provider satisfaction was high.

5. e-ce.org e-ce.org/journal/view.php?number=7909

Remimazolam, a novel drug, for safe and effective ... These findings suggest that remimazolam is safer for older patients undergoing deep sedation. In another trial, a 95% effective dose (ED95) for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12570234/

Efficacy and safety of remimazolam for sedation during ... Remimazolam had a lower incidence of adverse effects, including hypotension (RR = 0.21, 95% CI 0.11–0.41), bradycardia (RR = 0.12, 95% CI 0.02– ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12060368/

The safety and efficacy of remimazolam, ciprofol, and propofol ... Remimazolam demonstrated superior cardiovascular safety (RR = 0.44, 95%CrI 0.35–0.54 vs propofol) and lowest respiratory depression risk (RR = 0.36, 0.28–0.46).

8. apsf.org apsf.org/article/remimazolam-patient-safety-considerations-of-a-novel-practice-changing-drug-in-perioperative-medicine/

Remimazolam: Patient Safety Considerations of a Novel ... There are early conflicting and limited data regarding remimazolam and its potential link to postoperative nausea and vomiting. It likely leads to a reduction ...