The Use of Remimazolam for TEE

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07829458
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Anesthesia
  • Cardiac Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Sep 21, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Propofol group
    Control group receiving standard therapy. 50-100mg/kg/min titrated at the discretion of the anesthesiology team
  • Experimental: Remimazolam group
    Study group receiving study drug 0.1-0.2mg/kg/min titrated to effect

Primary Outcome Measure

Incidence of intra-procedural hypotension [ Time Frame: during procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai MorningsideNew YorkNew York10025
Himani V. Bhatt (PRINCIPAL_INVESTIGATOR)

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By research site
Mount Sinai Morningside· New York, NY

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