Remimazolam vs Midazolam for Cataract

Overseen By Stephanie-Dee Sarovich, BS

Age: 65+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Los Angeles

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two anxiety-reducing medications, Midazolam and Remimazolam, in elderly patients having cataract surgery. The goal is to see if Remimazolam causes fewer cognitive side effects compared to Midazolam. Patients will take a cognitive test to measure any changes. Remimazolam is a newly developed medication with quicker effects than Midazolam.

Research Team

Zhuang Fang, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for adults over 65 who are having their first cataract surgery at UCLA and can follow simple English commands. They should be in stable health but not severely overweight, have sleep apnea, chronic pain on opiates, or a history of certain allergies or substance abuse.

Inclusion Criteria

I am over 65 and having my first cataract surgery at UCLA.

I am either male or female.

American Society of Anesthesiologists Class 2, 3, and 4

Exclusion Criteria

I have moderate to severe obstructive sleep apnea.

Patients with a history of drug, alcohol abuse/dependence

Patients who are unable to understand simple English commands

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either Midazolam or Remimazolam during cataract surgery

1 day

1 visit (in-person)

Postoperative Assessment

Cognitive changes assessed using MoCA test immediately following surgery in the PACU and patient satisfaction survey completed

1 day

1 visit (in-person)

Follow-up

Participants are monitored for cognitive changes and satisfaction the day after surgery

1 day

1 visit (in-person)

Treatment Details

Interventions

• Midazolam
• Remimazolam

Trial Overview The study compares the effects of two sedatives—Midazolam and Remimazolam—on patients' cognitive function after cataract surgery. Cognitive changes are measured using the MoCA test before surgery, upon discharge from post-op care, and the following day.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Patients assigned to the study group will receive Remimazolam.

Group II: Control Active Control 1 Intervention

Patients assigned to the control group will receive Midazolam.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+