A Phase 4 interventional study of Remimazolam and Propofol in Cardiac Disease and Anesthesia, sponsored by Icahn School of Medicine at Mount Sinai. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 4, Interventional, and Treatment
Among 645 studies in Heart Diseases with a site in United States — 92 open to participants now, 130 under way, 5 of them phase 3. Heart Diseases · United States.
Among the 645 studies in Heart Diseases with a site in United States, this one is the 183rd largest by planned enrollment of the 429 interventional ones that give a count, is one of 27 that started in 2026, is one of 36 in phase 4, reaches primary completion later than 63 of the 127 other live ones, and was the 642nd registered.
2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.
This study's planned enrollment of 210 is above the median of 129 across 931 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →92 of the 645 studies in Heart Diseases with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 180 Heart Diseases studies recruiting now, 128 (71%) set no upper age limit and 21 (12%) stop at 75 or younger; 32 take children under 18; 42 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →645 studies; the count open now beside each. This study's row is marked.
First in 1973; this study’s year is marked. 27 started in 2026.
Median enrollment 160 across the 429 interventional studies, 300 across the 206 observational. Of the 469 that completed or were terminated, 158 (34%) have results posted.
183 of 645 have an industry lead sponsor. The 10 most frequent:
Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Icahn School of Medicine at Mount Sinai has 4 studies filed under Heart Diseases — fewer than ten, so there is no comparison to draw.
40 of the studies in Heart Diseases with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06077422Phase 3Rutgers, The State University of New JerseyExparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain | 2027-01-11 |
| NCT05153967Vanderbilt University Medical CenterCooperative Assessment of Late Effects for SCD Curative Therapies | 2026-11 |
| NCT06891222Mayo ClinicA Study of Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening | 2026-11 |
| NCT06703489Medtronic Cardiac Ablation SolutionsSafety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS) | 2026-11 |
| NCT02694094Johns Hopkins UniversityImpact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy | 2026-12 |
Among the 645 studies in Heart Diseases with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control group receiving standard therapy. 50-100mg/kg/min titrated at the discretion of the anesthesiology team
Drug: Propofol
Study group receiving study drug 0.1-0.2mg/kg/min titrated to effect
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.
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.
Incidence of intra-procedural hypotension
Incidence of intra-procedural hypotension defined as MAP \<65 mmHg or \>20% decrease from baseline.
Time frame: during procedure
Number of Procedural Success
Successful completion of TEE without conversion to general anesthesia or change in sedative strategy.
Time frame: Immediately after procedure
Time to recovery
Time from completion of TEE to recovery adequate for discharge from the procedural recovery area.
Time frame: 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.
Time frame: up to 24 hours
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol, Informed consent form
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.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 24 phase 4 interventional studies under Heart Diseases, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 75. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Remimazolam
Icahn School of Medicine at Mount Sinai →