Remimazolam for Cataract Surgery

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT05980117
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cataract Surgery
  • Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Remimazolam — DRUG
    Remimazolam (1.0mg IV) titrated to modified observer's assessment of sedation score of 3 -4 during cataract surgery.
  • Midazolam — DRUG
    Midazolam (0.5-2mg IV) titrated to modified observer's assessment of sedation score of 3 - 4 during cataract surgery.

Study Details

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)

Key Dates

Start date
Mar 10, 2025
Status verified
Mar 2025
Primary completion
Dec 31, 2025
Completion
Jan 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    Patients assigned to the study group will receive Remimazolam.
  • Active Comparator: Control
    Patients assigned to the control group will receive Midazolam.

Primary Outcome Measure

Change in MoCA score following surgery in the PACU and post operative day 1. [ Time Frame: Immediately following surgery in the PACU and post operative day 1. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative MedicineLos AngelesCalifornia90095
Stephanie-Dee Sarovich, B.S.
[email protected]
424-832-6842
Gundappa Neelakanta, M.D. (SUB_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine· Los Angeles, CA

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