Cataract Oral vs IV Sedation Pilot RCT: A Non-inferiority Assessment of Perioperative Safety and Cognitive Recovery in Older Adults
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The goal of this clinical trial is to find out if taking a pill (oral sedation) works just as well as getting medicine through a vein (IV sedation) to help older adults feel relaxed during cataract surgery. We are also studying how these two methods affect recovery, especially thinking and memory after surgery, and how satisfied people are with their care. Participants in this study will be randomly assigned to receive either oral sedation (+ IV placebo) or IV sedation (+ oral placebo) before their cataract surgery. They will complete short surveys about their thinking and recovery before and after surgery, and will be contacted by phone after surgery to check on their recovery. The results of this study will help doctors understand if a simple pill can be a safe and effective alternative to IV sedation for cataract surgery.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• ≥ 65 years old
• Capable of providing informed consent and completing the study procedures in English
• Able to provide consent for oneself
• Able to follow directions
• Able to climb one flight of stairs without stopping to rest
• Have a new diagnosis of cataract disease
• Plan on having cataract surgery on their eye within the next 6 months
Locations
United States
California
UCSF Wayne and Gladys Valley Center for Vision, Mission Bay
RECRUITING
San Francisco
Contact Information
Primary
Jacob A Flores, MPH
jacob.flores@ucsf.edu
5598539089
Backup
Catherine L Chen, MD, MPH
catherine.chen@ucsf.edu
4108688440
Time Frame
Start Date:2025-08-12
Estimated Completion Date:2025-11
Participants
Target number of participants:20
Treatments
Experimental: Oral Sedation Group
Participants in this group will receive oral sedation with alprazolam (0.5 mg) and IV placebo prior to cataract surgery. All participants will undergo standard cataract surgery with local anesthetic eye drops and continuous anesthesia monitoring. An IV line will be placed for monitoring, and anesthesia staff will be present during surgery, with the option to administer additional sedation if clinically indicated.
Active_comparator: IV Sedation Group
Participants in this group will receive IV sedation with midazolam (1 mg) and an oral placebo pill prior to cataract surgery. All participants will undergo standard cataract surgery with local anesthetic eye drops and continuous anesthesia monitoring. An IV line will be placed for monitoring, and anesthesia staff will be present during surgery, with the option to administer additional sedation if clinically indicated.