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NCT Number: NCT07829458

The Use of Remimazolam for TEE

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.

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Key information

Conditions

Cardiac Disease Anesthesia Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mount Sinai Morningside

New York, 10025, United States

Location contact

Himani V. Bhatt

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age and older
  • all cardiac patients undergoing elective TEE examination

Exclusion criteria

  • Patients with hypersensitivity to dextrans
  • Emergent procedures
  • Patient with allergy to any of the anesthetic agents
  • Patient refusal

Treatment and study plan

Remimazolam

Drug

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.

Propofol

Drug

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.

Primary outcomes

  1. Incidence of intra-procedural hypotension

    Time frame: during procedure

    Incidence of intra-procedural hypotension defined as MAP <65 mmHg or >20% decrease from baseline.

Secondary outcomes

  1. Number of Procedural Success

    Time frame: Immediately after procedure

    Successful completion of TEE without conversion to general anesthesia or change in sedative strategy.

  2. Time to recovery

    Time frame: Time in recovery area, average of 2-4 hours

    Time from completion of TEE to recovery adequate for discharge from the procedural recovery area.

  3. Incidence of treatment-related adverse events

    Time frame: up to 24 hours

    Incidence of treatment-related adverse events, including hypotension, bradycardia, hypoxia, nausea/vomiting, and need for vasoactive medications or rescue sedation.

Study contacts

Contact information is provided by the study sponsor or research team.

Himani V. Bhatt

CONTACT

[email protected]

212-523-6915

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Remimazolam for Procedural Sedation in Cardiac Patients Undergoing Transesophageal Echocardiogram Procedures

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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