Study of Remimazolam for Cataract Surgery

Remimazolam for Sedation in Cataract Surgery, A Phase IV, On-label, Blinded Study

The goal of this clinical trial is to learn if the use of the sedative remimazolam improves the safety of patients having cataract surgery by decreasing the number of sedation-related complications during and after surgery, and shortening post-surgical cognitive recovery time.

Remimazolam (Byfavo) is a novel benzodiazepine approved by the U.S. Food and Drug Administration in July 2020 for sedation in patients undergoing procedures less than 30 minutes in duration. Remimazolam is a rapid onset/offset benzodiazepine, designed to be rapidly metabolized without active metabolites reduce the changes in cognitive function known to occur after even a brief exposure to a sedative. This study will use remimazolam on-label to sedate patients having cataract surgeries that take less than 30 minutes to perform. The investigator is studying the use of remimazolam in cataract surgery because the investigator think it will improve patient safety by shortening post-surgery cognitive recovery time and decreasing the number of sedation-related complications.

Inclusion Criteria:

• Subject is planning to have cataract surgery in both eyes
• The surgeon estimates that each cataract surgery are estimated to take less than 30 minutes
• Subject is aged 55 to 90 years old
• Surgeries will take place on the main campus of Mass Eye and Ear at 243 Charles St., Boston for at least the first year. In the future, surgeries may also occur at Mass Eye and Ear Longwood Surgical Ambulatory Care Center.
• Subject is able to understand the consent form and sign the consent
• ASA 1-3 (possible breakdown numbers of 5, 10, 10, 5)

Exclusion Criteria • Subject does not speak or read English

• Subject has a history of difficulty with sedation during procedures
• The surgeon estimates that one of the planned cataract surgeries is estimated to take longer than 30 minutes
• Subject uses concomitant home narcotic or anxiolytic
• Subject uses O2
• Subject has a history of cognitive decline
• A history of severe hepatic impairment