Oral vs IV Sedation for Cataract Surgery in Older Adults
Cataract Oral vs IV Sedation Pilot RCT: A Non-inferiority Assessment of Perioperative Safety and Cognitive Recovery in Older Adults
University of California, San Francisco
20 participants
Aug 12, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- ≥ 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
Exclusion Criteria8
- History of prior cataract surgery
- Admission to the hospital within the past 30 days
- Difficulty being sedated during other minor outpatient procedures or imaging studies
- Allergy or resistance to local anesthetic agents
- Cannot lay flat without having symptoms (i.e., difficulty breathing, severe back pain, etc.)
- History of severe anxiety requiring routine use of benzodiazepines
- Patient undergoing cataract surgery in combination with any other ophthalmologic procedure
- Patient requiring general anesthesia during cataract surgery due to the underlying characteristics of the existing cataract and/or anticipated complexity of the planned procedure
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Interventions
Participants will take oral alprazolam 0.5 mg 15 to 90 minutes before surgery to promote relaxation and reduce anxiety. An IV placebo (normal saline) will be administered to maintain blinding.
Participants will receive IV midazolam 1 mg immediately before surgery to promote relaxation and reduce anxiety. An oral placebo pill will be used to maintain blinding.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07154147