Remimazolam vs Propofol for Anesthesia

Overseen By Justin Routman

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Alabama at Birmingham

Disqualifiers: Emergent TEE, ICU, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drugs Remimazolam and Propofol for anesthesia?

Research shows that Remimazolam is as effective as Propofol for general anesthesia, with both drugs providing rapid recovery. In some cases, using them together may allow for lower doses and quicker recovery times. ^{1 2 3 4 5}

Is remimazolam safe compared to propofol for anesthesia?

Research shows that remimazolam is generally safe and may have fewer side effects than propofol, such as less risk of low blood pressure and breathing problems. It is considered a safe alternative for anesthesia in various procedures. ^{1 2 6 7 8}

How does remimazolam differ from propofol for anesthesia?

Remimazolam is a new, ultra-short-acting benzodiazepine that offers rapid recovery and can be reversed with flumazenil, making it potentially faster for patients to wake up compared to propofol. It also allows for dose reduction when used with propofol, which may help avoid delayed recovery. ^{1 2 4 9 10}

What is the purpose of this trial?

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.

Eligibility Criteria

Adults aged 18 or older scheduled for elective/non-emergent transesophageal echocardiography (TEE) at the UAB Heart and Vascular Center TEE Lab can participate in this trial.

Inclusion Criteria

I am 18 or older and scheduled for a planned heart ultrasound at UAB.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either remimazolam or propofol for sedation during the TEE procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after sedation

4 weeks

Treatment Details

Interventions

• Propofol
• Remimazolam

Trial Overview The study compares two sedatives: remimazolam, a new FDA-approved drug, versus propofol, which is currently used. It aims to see if remimazolam improves patient hemodynamics and procedural efficiency during TEE.

Participant Groups

Group I: Remimazolam Experimental Treatment 1 Intervention

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

Group II: Propofol Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Quality of Recovery After General Anesthesia with Remimazolam in Patients' Undergoing Urologic Surgery: A Randomized Controlled Trial Comparing Remimazolam with Propofol. [2023]

2. Italy pubmed.ncbi.nlm.nih.gov

Safety and efficacy of remimazolam compared with propofol in induction of general anesthesia. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Remimazolam besylate versus propofol for deep sedation in critically ill patients: a randomized pilot study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Total intravenous anesthesia management with simultaneous use of remimazolam and propofol: A case series of three patients. [2023]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison of remimazolam-remifentanil and propofol-remifentanil during laparoscopic cholecystectomy. [2023]

6. Italy pubmed.ncbi.nlm.nih.gov

Comparison of remimazolam and propofol about safety outcome indicators during general anesthesia in surgical patients: a systematic review and meta-analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The safety and efficacy between remimazolam and propofol in intravenous anesthesia of endoscopy operation: a systematic review and meta-analysis. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and efficacy of remimazolam besylate in patients undergoing colonoscopy: A multicentre, single-blind, randomized, controlled, phase Ⅲ trial. [2022]

9. Japan pubmed.ncbi.nlm.nih.gov

Safety and efficacy of remimazolam in induction and maintenance of general anesthesia in high-risk surgical patients (ASA Class III): results of a multicenter, randomized, double-blind, parallel-group comparative trial. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Remimazolam-based anesthesia with flumazenil allows faster emergence than propofol-based anesthesia in older patients undergoing spinal surgery: A randomized controlled trial. [2023]