NCT05980117 Remimazolam for Cataract Surgery
| NCT ID | NCT05980117 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, Los Angeles |
| Condition | Cataract Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2025-03-10 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to assess any post operative cognitive changes following benzodiazepine administration during cataract surgery. The investigators will compare effects of Midazolam vs. Remimazolam on cognition at the time of discharge from the post operative care unit and the next day following surgery. Cognitive changes will be assessed by administration of Montreal Cognitive Assessment (MoCA). Participants will: 1. Complete MoCA testing prior to surgery 2. Randomize in either Midazolam or study drug Remimazolam 3. Complete MoCA testing after surgery at the time of discharge in the post anesthesia care unit and the next day of surgery at the time of post operative surgical visit. 4. Complete Patient Satisfaction Survey at the time of discharge from the Post Anesthesia Care Unit (PACU)
Eligibility 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).
Contact & Investigator
Zhuang Fang, MD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT05980117 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Cataract Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05980117 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05980117 currently recruiting?
Yes, NCT05980117 is actively recruiting participants. Contact the research team at ZFang@mednet.ucla.edu for enrollment information.
Where is the NCT05980117 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05980117 clinical trial?
NCT05980117 is sponsored by University of California, Los Angeles. The principal investigator is Zhuang Fang, MD at University of California, Los Angeles. The trial plans to enroll 120 participants.