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drugset / Trial / NCT06129188

Comparison of Procedural Sedation in TEE

NCT06129188 ↗

Phase 1 Completed 105 enrolled University of Alabama at Birmingham
RandomizedParallel-groupSingle-blindPrevention

Summary

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.

Timeline

Start
2025-02-25
Primary completion
2025-11-26
Completion
2025-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Propofol Small molecule — Intravenous
Subject Remimazolam Small molecule 2.5 mg Intravenous
Subject Remimazolam Small molecule 5 mg Intravenous

Indications

No indication recorded.