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Remimazolam for Cataract Surgery

RecruitingPhase 4Ages 65 Years - anyAllUniversity of California, Los Angeles
NCT05980117 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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)

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📋 Eligibility rules (as published)
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).
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What it tests

  • Remimazolam
  • Midazolam
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Where

1 site
Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
Los Angeles, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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