RECRUITINGPhase 4INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. ≥ 65 years old 2. Capable of providing willing to sign a consent form and completing the study procedures in English 3. Able to provide consent for oneself 4. Able to follow directions 5. Able to climb one flight of stairs without stopping to rest 6. Have a new diagnosis of cataract disease 7. Plan on having cataract surgery on their eye within the next 6 months Who Should NOT Join This Trial: 1. History of prior cataract surgery 2. Admission to the hospital within the past 30 days 3. Difficulty being sedated during other minor outpatient procedures or imaging studies 4. Allergy or resistance to local anesthetic agents 5. Cannot lay flat without having symptoms (i.e., difficulty breathing, severe back pain, etc.) 6. History of severe anxiety requiring routine use of benzodiazepines 7. Patient undergoing cataract surgery in combination with any other ophthalmologic procedure 8. Patient requiring general anesthesia during cataract surgery due to the underlying characteristics of the existing cataract and/or anticipated complexity of the planned procedure Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. ≥ 65 years old 2. Capable of providing informed consent and completing the study procedures in English 3. Able to provide consent for oneself 4. Able to follow directions 5. Able to climb one flight of stairs without stopping to rest 6. Have a new diagnosis of cataract disease 7. Plan on having cataract surgery on their eye within the next 6 months Exclusion Criteria: 1. History of prior cataract surgery 2. Admission to the hospital within the past 30 days 3. Difficulty being sedated during other minor outpatient procedures or imaging studies 4. Allergy or resistance to local anesthetic agents 5. Cannot lay flat without having symptoms (i.e., difficulty breathing, severe back pain, etc.) 6. History of severe anxiety requiring routine use of benzodiazepines 7. Patient undergoing cataract surgery in combination with any other ophthalmologic procedure 8. Patient requiring general anesthesia during cataract surgery due to the underlying characteristics of the existing cataract and/or anticipated complexity of the planned procedure

Treatments Being Tested

DRUG

Alprazolam

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.

DRUG

Midazolam

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)

UCSF Wayne and Gladys Valley Center for Vision, Mission Bay

San Francisco, California, United States