Remimazolam for Sedation in Cataract Surgery, A Phase IV, On-label, Blinded Study
Fred E, Shapiro
Summary
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.
Description
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 sur…
Eligibility
- Age range
- 55–90 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DrugArm 1 Cataract Surgery performed with remimazolam as sedative
Sedation will be remimazolam in one eye and the standard of care in the other eye.
- DrugArm 2 Cataract Surgery performed with standard of care sedative
Standard of care sedative will be used during surgery.
Location
- Massachusetts Eye and Ear InfirmaryBoston, Massachusetts