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Comparison of Procedural Sedation in TEE

NCT06129188 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-12-22

No results posted yet for this study

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.

Conditions

  • Anesthesia

Interventions

DRUG

Remimazolam

Remimazolam is an ultra-short acting benzodiazepine medication. Benzodiazepines are a class of drug that directly interact with gamma-aminobutyric acid (GABA) and modifiable chloride channels through polysynaptic pathway inhibition. The anxiolytic properties of benzodiazepines make them useful as sedatives.

DRUG

Propofol

Standard of care usage of the intravenous anesthetic agent propofol to achieve adequate sedation conditions for the procedure.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-25
Primary Completion
2025-11-26
Completion
2025-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06129188 on ClinicalTrials.gov