Oral vs IV Sedation for Cataract Surgery in Older Adults (CatNAPS-2)

University of California San Francisco (UCSF)

Status and phase: Enrolling; Phase 4

Conditions: Perioperative Care; Older Adults; Sedation; Cataract Surgery; Cognition Function

Treatments: Drug: Alprazolam; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT07154147

25-43837

Details and patient eligibility

About

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.

Full description

This clinical trial is designed to compare two common ways of providing sedation during cataract surgery in older adults: oral sedation (a pill) and intravenous (IV) sedation (medicine given through a vein). Cataract surgery is a quick and safe procedure that helps people see better by removing the cloudy lens in their eye. While numbing eye drops are routinely used to prevent pain, many people also receive sedation to feel calm during surgery. In the United States, IV sedation is commonly used and requires close monitoring by an anesthesia team. In other countries, oral sedation is often used instead because it is simpler and less resource-intensive.

The goal of this study is to see if oral sedation can provide the same level of safety, comfort, and recovery as IV sedation. Researchers are especially interested in how each type of sedation affects a person's thinking, memory, and overall recovery in the days after surgery. The study also looks at how satisfied participants are with their care, whether they experience side effects, and whether surgeons feel the surgery goes smoothly with each type of sedation.

This is a small, pilot study that will enroll 20 adults aged 65 and older who are scheduled for cataract surgery. Participants will be randomly assigned by chance (like flipping a coin) to one of two groups: one group will receive a pill called alprazolam and a harmless IV placebo, while the other group will receive a placebo pill and standard IV sedation with a medication called midazolam. Everyone will still get numbing eye drops and be monitored by an anesthesia team during surgery for safety.

Participants will complete simple memory and recovery tests before and after surgery, and follow-up phone calls will check on how they are feeling up to seven days after surgery. By closely monitoring thinking ability, comfort, and safety, this study aims to provide important information about whether oral sedation could be a good option for people undergoing cataract surgery in the United States. The results will help guide future research and inform doctors about the best ways to care for older adults during eye surgery.

Enrollment: 20 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Oral Sedation Group

Experimental group

Description:

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.

Treatment:

Drug: Alprazolam

IV Sedation Group

Active Comparator group

Description:

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.

Treatment:

Drug: Midazolam