Comparing two sedatives for patients undergoing transesophageal echocardiography
Comparison of Remimazolam With Propofol for Procedural Sedation in TEE
This study is testing whether a new sedative called remimazolam works better than the usual sedative propofol for patients having a special heart test called transesophageal echocardiography.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06129188 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of a new sedative, remimazolam, against the commonly used propofol in patients undergoing transesophageal echocardiography (TEE) at the University of Alabama at Birmingham. The study will assess whether remimazolam provides better hemodynamic stability and procedural efficiency compared to propofol. Eligible participants include both inpatients and outpatients aged 18 and older scheduled for elective or non-emergent TEE procedures. The trial will be conducted in a randomized manner to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective or non-emergent transesophageal echocardiography at the UAB Heart and Vascular Center.
Not a fit: Patients undergoing emergent TEE procedures or those with specific exclusions such as being under 19 years old or pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sedation practices, enhancing patient safety and comfort during TEE procedures.
How similar studies have performed: While this approach is novel in the context of TEE sedation, previous studies have indicated that remimazolam may offer advantages over traditional sedatives, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inpatients and outpatients \>=18 years who are scheduled to undergo elective/non-emergent transesophageal echocardiography at the UAB Heart and Vascular Center TEE Lab. Exclusion Criteria: * Patients undergoing emergent TEE procedure in the HVC TEE Lab. * Patients undergoing elective or emergent TEE procedure in the ICU and/or at the patient bedside. * Patients undergoing elective or emergent TEE procedure in a location other than HVC TEE Lab. * Patients undergoing an additional procedure or surgery (before or after TEE) as part of the same anesthetic, except for DC Cardioversion. * Children under the age of 19 years (or under 50 kg body weight if age is unknown). * Pregnant patients. * Breastfeeding/nursing patients. * Incarcerated patients. * Patients enrolled in a concurrent ongoing interventional randomized clinical trial.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Justin Routman
- Email: jroutman@uabmc.edu
- Phone: 205-934-4696
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.