Comparison of Procedural Sedation in TEE

NCT06129188 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: IRB-300011945UAB
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this proposal is to conduct a prospective randomized study comparing the utility of sedating patients undergoing transesophageal echocardiographic studies with a novel, recently-FDA-approved sedative agent, remimazolam, versus the sedative used in our current practice at UAB, propofol. This study will investigate whether remimazolam offers any benefit over current care vis-à-vis hemodynamics or efficiency/throughput. This study will be conducted at the University of Alabama at Birmingham. All outpatients and inpatients scheduled for elective/non-emergent TEE in the UAB Heart and Vascular Center TEE lab will be considered for enrollment.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (2)

• Blood pressure, physiologic parameter

  All patient blood pressure values (systolic and diastolic) recorded on the intraoperative anesthesia record.

  Only blood pressures recorded on the anesthesia record during the anesthetic administered for the TEE procedure.

• Heart rate, physiologic parameter

  All patient heart rate values recorded on the intraoperative anesthesia record.

  Only heart rate recorded on the anesthesia record during the anesthetic administered for the TEE procedure.

Secondary Outcomes (4)

• Level of sedation, using the validated MOAA/S observer scale

  Only values recorded during the TEE procedure

• Duration of onset of sedation, using the validated MOAA/S observer scale

  Only values recorded during the TEE procedure

• Duration of procedure, recorded parameter

  Only value recorded during the TEE procedure

• Medication administration, recorded parameter

  Only values recorded during the TEE procedure.

Study Arms (2)

Remimazolam

EXPERIMENTAL

2.5-5 mg IV remimazolam will be administered no more frequently than every 2 minutes for the duration of the TEE procedure.

Drug: Remimazolam

Propofol

ACTIVE COMPARATOR

Standard-of-care IV propofol administration will be administered at the discretion of the anesthesia team caring for the patient for the duration of the TEE procedure

Drug: Propofol

Interventions

Propofol DRUG

Standard of care usage of the intravenous anesthetic agent propofol to achieve adequate sedation conditions for the procedure.

Also known as: Diprivan

Propofol

Remimazolam DRUG

Remimazolam is an ultra-short acting benzodiazepine medication. Benzodiazepines are a class of drug that directly interact with gamma-aminobutyric acid (GABA) and modifiable chloride channels through polysynaptic pathway inhibition. The anxiolytic properties of benzodiazepines make them useful as sedatives.

Also known as: Byfavo

Remimazolam

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatients and outpatients \>=18 years who are scheduled to undergo elective/non-emergent transesophageal echocardiography at the UAB Heart and Vascular Center TEE Lab.

You may not qualify if:

• Patients undergoing emergent TEE procedure in the HVC TEE Lab.
• Patients undergoing elective or emergent TEE procedure in the ICU and/or at the patient bedside.
• Patients undergoing elective or emergent TEE procedure in a location other than HVC TEE Lab.
• Patients undergoing an additional procedure or surgery (before or after TEE) as part of the same anesthetic, except for DC Cardioversion.
• Children under the age of 19 years (or under 50 kg body weight if age is unknown).
• Pregnant patients.
• Breastfeeding/nursing patients.
• Incarcerated patients.
• Patients enrolled in a concurrent ongoing interventional randomized clinical trial.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Of note, given the differences between propofol (premixed suspension, white color, weight-based dosing, often given via infusion, boluses typically vary from 3-10 mL doses) and remimazolam (requires reconstitution, clear color when reconstituted, non-weight-based dosing, only FDA approved for intermittent bolus administration, only FDA approved for boluses of 1-2 mL doses), it would not be possible for providers to be blinded to treatment group. Subjects and observers monitoring the MOAA/S level of sedation, however, will be blinded to treatment group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: After consenting to participate in the study, participants will undergo randomization in to one of two groups: those receiving remimazolam for sedation and those receiving propofol for sedation.

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 13, 2023
• Study Start: February 25, 2025
• Primary Completion: November 26, 2025
• Study Completion: December 1, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)