Comparison of Procedural Sedation in TEE
Completed · Phase 1
Conditions studied: Anesthesia
In brief
The objective of this proposal is to conduct a prospective randomized study comparing the utility of sedating patients undergoing transesophageal echocardiographic studies with a novel, recently-FDA-approved sedative agent, remimazolam, versus the sedative used in our current practice at UAB, propofol. This study will investigate whether remimazolam offers any benefit over current care vis-à-vis hemodynamics or efficiency/throughput. This study will be conducted at the University of Alabama at Birmingham. All outpatients and inpatients scheduled for elective/non-emergent TEE in the UAB Heart and Vascular Center TEE lab will be considered for enrollment.
Key facts
- Study ID
- NCT06129188
- Run by
- University of Alabama at Birmingham
- People needed
- 105
- Starts
- 2025-02-25
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-12-22
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Inpatients and outpatients >=18 years who are scheduled to undergo elective/non-emergent transesophageal echocardiography at the UAB Heart and Vascular Center TEE Lab.
You may not qualify if…
- 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 it is running
- University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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