Status:
RECRUITING
Remimazolam for Cataract Surgery
Lead Sponsor:
University of California, Los Angeles
Conditions:
Cataract Surgery
Cognitive Impairment
Eligibility:
All Genders
65+ years
Phase:
PHASE4
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. Remima...
Detailed Description
Cataract surgery (clouded natural lens of eye removed and clear artificial lens implanted) is the most common eye surgery performed in elderly patients. Although cataract surgery is a minor surgery, m...
Eligibility Criteria
Inclusion
- Adult patients age \> 65 years undergoing first eye cataract surgery under local topical anesthesia at the University of California, Los Angeles (UCLA).
- Both male and female patients
- American Society of Anesthesiologists Class 2, 3, and 4.
Exclusion
- Patients who are unable to consent for the study
- Patients who are unable to cooperate with the cognitive assessment such as patients with significant visual, auditory, language or other impairment.
- Patients who are unable to understand simple English commands.
- Patients who do not wish to have benzodiazepine medication during surgery
- Patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40.
- Patients with chronic pain on opiates.
- Patients with a history of drug, alcohol abuse/dependence.
- Patients with BMI \> 40.
- Patients with obstructive sleep apnea (moderate to severe).
Key Trial Info
Start Date :
March 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05980117
Start Date
March 10 2025
End Date
January 1 2026
Last Update
March 19 2025
Active Locations (1)
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1
Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
Los Angeles, California, United States, 90095