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

Must not be taking: Opiates

Disqualifiers: Drug abuse, BMI > 40, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify any changes in thinking skills after using two different drugs, Midazolam (also known as Versed, Hypnovel, or Dormicum) and Remimazolam, during cataract surgery. Researchers seek to determine if one drug affects the brain more than the other immediately after surgery and the following day. Suitable candidates for this trial are individuals over 65 undergoing their first cataract surgery at UCLA who can understand simple English. Participants will take a short test before and after surgery to assess their thinking skills. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand its benefits for more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on opiates for chronic pain, you cannot participate in the trial.

What is the safety track record for these treatments?

Research shows that both Remimazolam and Midazolam are generally safe during medical procedures. Studies have found that Remimazolam is usually well-tolerated, with a low chance of side effects like sleepiness or slight changes in blood pressure and heart rate. Most people do not experience serious issues with its use.

Midazolam is also considered safe and is commonly used in medical settings, though some people might feel sleepy or dizzy after taking it. Both drugs belong to benzodiazepines, which help relax and calm patients during surgeries.

In past studies, most patients did not report serious problems with either drug. Discuss any concerns with a healthcare provider, especially if existing health conditions are present. This ensures the best and safest outcome when considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Remimazolam is unique because it is a new sedative designed to work quickly and wear off faster than traditional options like Midazolam, which is commonly used during cataract surgery. This rapid onset and recovery can be particularly beneficial, making procedures smoother and potentially reducing recovery time for patients. Researchers are excited about Remimazolam because it may offer a more controlled and shorter sedation experience, which is ideal for outpatient procedures like cataract surgery.

What evidence suggests that this trial's treatments could be effective for cognitive changes after cataract surgery?

This trial will compare Remimazolam and Midazolam for cataract surgery. Research has shown that Remimazolam, which participants in this trial may receive, is effective and safe for use in surgeries, particularly for older adults. It performs well for general anesthesia, with studies identifying doses that are both effective and safe. Midazolam, the comparator in this trial, is a well-known sedative frequently used in surgeries. Both Remimazolam and Midazolam belong to a group of drugs called benzodiazepines, which help calm and sedate patients. Although Remimazolam is newer, recent studies support its effectiveness, making it a promising alternative to Midazolam. ^{1 3 6 7 8}

Who Is on the Research Team?

Zhuang Fang, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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.

American Society of Anesthesiologists Class 2, 3, and 4

I am either male or female.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05980117?term=Cataract%2018&viewType=Table&rank=7

NCT05980117 | Remimazolam for Cataract Surgery Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

2. uclahealth.org uclahealth.org/clinical-trials/remimazolam-cataract-surgery

Remimazolam for Cataract Surgery The goal of this study is to assess any post operative cognitive changes following benzodiazepine administration during cataract surgery.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12416394/

Determination of the 90% Effective Dose of Remimazolam ... Therefore, our results suggest the dose of 1.1 and 1.2 mg/kg/h of remimazolam infusion are an effective and safety dose for the study ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12060543/

Comparative study of the efficacy and safety of remimazolam ... General anesthesia with remimazolam has been shown to be effective and safe for surgery in elderly patients.

5. trial.medpath.com trial.medpath.com/clinical-trial/85eb6a76e12b029c/nct05980117-comparison-remimazolam-vs-midazolam-sedation-cataract-surgery

Remimazolam for Cataract Surgery | MedPath The goal of this study is to assess any post operative cognitive changes following benzodiazepine administration during cataract surgery.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12482367/

Efficacy and safety of remimazolam for induction and ... The secondary outcomes included mean arterial pressure (MAP), heart rate (HR), time to loss of consciousness (LOC), injection pain, ...

7. aao.org aao.org/eyenet/article/anesthesiology-in-a-changing-cataract-landscape

Anesthesiology in a Changing Cataract Landscape However, data suggest that risk of bradycardia, hypertensive episodes, postoperative drowsiness, and other adverse events are more associated ...

8. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.641866/full

Efficacy and Safety of Remimazolam for Procedural Sedation The pooled data showed that the use of remimazolam resulted in a higher rate of procedure success, lesser administration of rescue medication, ...