The Use of Remimazolam for TEE
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age and older
all cardiac patients undergoing elective TEE examination
Disqualifiers
Patients with hypersensitivity to dextrans
Emergent procedures
Patient with allergy to any of the anesthetic agents
Patient refusal
Trial design
Design model
Parallel
Treatments tested in this trial
Remimazolam
DrugAn 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
DrugAn 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.
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: Propofol groupActive comparator 1 intervention
Group B: Remimazolam groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of intra-procedural hypotension
Incidence of intra-procedural hypotension defined as MAP \<65 mmHg or \>20% decrease from baseline.
Time frame
during procedureSecondary outcomes
1
Number of Procedural Success
Successful completion of TEE without conversion to general anesthesia or change in sedative strategy.
Time frame
Immediately after procedure2
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 hours3
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 hoursSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: