Comparison of Procedural Sedation in TEE

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Propofol

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.