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

The goal of this clinical trial is to evaluate the feasibility of comparing oral sedation (a pill) with intravenous (IV) sedation for cataract surgery in older adults. Investigators will assess the feasibility, completeness, and distribution of data related to postoperative recovery, including thinking and memory, as well as participant satisfaction with care. Participants will be randomly assigned to receive either oral sedation with an IV placebo or IV sedation with an oral placebo before cataract surgery. Participants will complete brief surveys assessing recovery before and after surgery and will be contacted by phone after surgery to assess postoperative recovery. Results from this pilot study will inform the design of a future, fully powered trial evaluating sedation approaches for cataract surgery.

This pilot clinical trial is designed to assess the feasibility of comparing two commonly used approaches to sedation during cataract surgery in older adults: oral sedation and intravenous (IV) sedation. Cataract surgery is a brief and commonly performed procedure that typically uses topical anesthetic eye drops, with sedation provided to promote comfort and relaxation. In the United States, IV sedation is frequently used and requires anesthesiology support and monitoring, whereas oral sedation is more commonly used in other settings because it is simpler to administer and less resource-intensive.

The primary focus of this study is to evaluate the feasibility, completeness, and distribution of data collection related to postoperative cognitive recovery using validated assessment tools. Secondary aims include descriptive assessments of participant satisfaction, surgeon satisfaction, recruitment success, participant retention, adherence to the assigned sedation intervention, intervention fidelity, intraoperative events, and postoperative anesthesia-related complications.

This pilot study will enroll 20 adults aged 65 years and older who are scheduled to undergo cataract surgery. Participants will be randomly assigned to receive either oral alprazolam with an IV placebo or a placebo pill with standard IV sedation using midazolam. All participants will receive topical ocular anesthesia and standard intraoperative monitoring by an anesthesia team. Cognitive recovery and other recovery outcomes will be assessed before surgery and during the postoperative period up to seven days after surgery. Findings from this study will be used to inform the design and implementation of a future, larger randomized trial.

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