Comparing Remimazolam and Midazolam for Cataract Surgery
Comparison of Remimazolam vs. Midazolam for Sedation During Cataract Surgery
This study is testing if a new anesthesia called Remimazolam can help older patients have better thinking skills after cataract surgery compared to the standard anesthesia, Midazolam.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05980117 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate postoperative cognitive changes in elderly patients undergoing cataract surgery by comparing the effects of two benzodiazepines: Midazolam and Remimazolam. Participants will be randomly assigned to receive either medication during surgery, and cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) before surgery, at discharge, and the following day. The study seeks to determine if Remimazolam, with its shorter half-life, results in fewer cognitive changes compared to Midazolam. Additionally, patient satisfaction regarding anesthesia will be measured at discharge.
Who should consider this trial
Good fit: Ideal candidates are adults over 65 years old who are undergoing their first eye cataract surgery under local topical anesthesia.
Not a fit: Patients who cannot consent, have significant cognitive impairments, or do not wish to receive benzodiazepines during surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive outcomes for elderly patients undergoing cataract surgery.
How similar studies have performed: Other studies have explored the effects of different anesthetics on cognitive outcomes, but this specific comparison of Remimazolam and Midazolam in cataract surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients age \> 65 years undergoing first eye cataract surgery under local topical anesthesia at the University of California, Los Angeles (UCLA). 2. Both male and female patients 3. American Society of Anesthesiologists Class 2, 3, and 4. Exclusion Criteria: 1. Patients who are unable to consent for the study 2. Patients who are unable to cooperate with the cognitive assessment such as patients with significant visual, auditory, language or other impairment. 3. Patients who are unable to understand simple English commands. 4. Patients who do not wish to have benzodiazepine medication during surgery 5. Patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40. 6. Patients with chronic pain on opiates. 7. Patients with a history of drug, alcohol abuse/dependence. 8. Patients with BMI \> 40. 9. Patients with obstructive sleep apnea (moderate to severe).
Where this trial is running
Los Angeles, California
- Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Zhuang Fang, MD — University of California, Los Angeles
- Study coordinator: Zhuang T Fang, MD
- Email: ZFang@mednet.ucla.edu
- Phone: 310-267-8946
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.