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Remimazolam for Cataract Surgery

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 19, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2025 to Mar 10, 2025
    • Site details revised
    v6
  2. Notable Primary completion date: May 2025 to Dec 2025
    • Start date: Jul 2024 to Jan 2025
    • Study completion date: Jun 2025 to Jan 2026
    v5
  3. Notable Primary completion date: Feb 2024 to May 2025
    • Start date: Jan 2024 to Jul 2024
    • Study completion date: May 2024 to Jun 2025
    v4
  4. Notable Start date: Sep 2023 to Jan 2024v3
  5. Minor Re-verified, no change to tracked fieldsv2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT05980117
Lead Sponsor University of California, Los Angeles
Conditions
(from sponsor)
Cataract Surgery, Cognitive Impairment
Related terms Cognitive Dysfunction
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov