Cardiac DiseasePhase 4NCT07829458
The Use of Remimazolam for TEE
A Phase 4 study testing Remimazolam and Propofol in people with Cardiac Disease and Anesthesia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease, Anesthesia
- What is being tested?
- Remimazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- all cardiac patients undergoing elective TEE examination
Who cannot join
- Patients with hypersensitivity to dextrans
- Emergent procedures
- Patient with allergy to any of the anesthetic agents
- Patient refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mount Sinai Morningside
New York, New York, 10025
Himani V. Bhatt
About this study
Official title: Remimazolam for Procedural Sedation in Cardiac Patients Undergoing Transesophageal Echocardiogram Procedures
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
- Being tested
- Remimazolam, Propofol
- Keywords
- Transesophageal echocardiogram, sedation anesthesia
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
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.
PropofolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Active comparator | Control group receiving standard therapy. 50-100mg/kg/min titrated at the discretion of the anesthesiology team Receives: Drug: Propofol |
| Remimazolam group | Experimental | Study group receiving study drug 0.1-0.2mg/kg/min titrated to effect Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intra-procedural hypotension
Incidence of intra-procedural hypotension defined as MAP <65 mmHg or >20% decrease from baseline.
Measured: during procedure
Secondary outcomes (3)
Number of Procedural Success
Successful completion of TEE without conversion to general anesthesia or change in sedative strategy.
Measured: Immediately after procedure
Time to recovery
Time from completion of TEE to recovery adequate for discharge from the procedural recovery area.
Measured: Time in recovery area, average of 2-4 hours
Incidence of treatment-related adverse events
Incidence of treatment-related adverse events, including hypotension, bradycardia, hypoxia, nausea/vomiting, and need for vasoactive medications or rescue sedation.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Himani Bhatt-Verma, Icahn School of Medicine at Mount Sinai
- Investigators
- Himani V. Bhatt, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829458
- Sponsor's protocol ID
- STUDY-22-00066
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.