The Use of Remimazolam for TEE

NCT07829458 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY-22-00066
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Disease; Anesthesia

Keywords

Transesophageal echocardiogram; sedation anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of intra-procedural hypotension

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

  during procedure

Secondary Outcomes (3)

• Number of Procedural Success

  Immediately after procedure

• Time to recovery

  Time in recovery area, average of 2-4 hours

• Incidence of treatment-related adverse events

  up to 24 hours

Study Arms (2)

Propofol group

ACTIVE COMPARATOR

Control group receiving standard therapy. 50-100mg/kg/min titrated at the discretion of the anesthesiology team

Drug: Propofol

Remimazolam group

EXPERIMENTAL

Study group receiving study drug 0.1-0.2mg/kg/min titrated to effect

Drug: Remimazolam

Interventions

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.

Remimazolam group

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.

Propofol group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Morningside

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

remimazolam; Propofol

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Himani V. Bhatt

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Himani V. Bhatt

CONTACT

212-523-6915; himani.bhatt@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 21, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. For individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.

Locations

US (1)