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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
210
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.
Mount Sinai Morningside
New York, New York, United States
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
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