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NOT YET RECRUITING
NCT07829458
PHASE4

The Use of Remimazolam for TEE

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

Summary

This is a prospective randomized study. The purpose of this study is to compare the use of remimazolam vs propofol (standard practice) for transesophageal echocardiogram (TEE). Remimazolam was approved by the Pharmacy and Therapeutics committee as a formulary addition to be utilized by anesthesiology for procedural sedation in October 2021. Cardiac patients undergoing TEE procedures at Mount Sinai Morningside Medical Center will be evaluated - 100 patients with be randomized to either receive remimazolam or standard anesthesia. Research participation will include the following activities: prospective access to the Medical Record through Epic only (no other database). Consent to collect patient data for this study will be obtained from subjects by the anesthesiologist at the same time as obtaining consent for the medical procedure.

Official title: Remimazolam for Procedural Sedation in Cardiac Patients Undergoing Transesophageal Echocardiogram Procedures

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2026-09

Completion Date

2027-09

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

DRUG

Remimazolam

An initial IV dose followed by supplemental IV doses administered by the anesthesia team, titrated to sedative effect consistent with FDA-approved dosing, for the duration of the TEE procedure.

DRUG

Propofol

An initial IV dose followed by supplemental IV doses administered by the anesthesia team, titrated to sedative effect consistent with FDA-approved dosing, for the duration of the TEE procedure.

Locations (1)

Mount Sinai Morningside

New York, New York, United States