Study of Remimazolam for Cataract Surgery

Fred E, Shapiro

Status and phase: Begins enrollment this month; Phase 4

Conditions: Cataract Surgery Anesthesia

Treatments: Drug: Arm 1 Cataract Surgery performed with remimazolam as sedative; Drug: Arm 2 Cataract Surgery performed with standard of care sedative

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07325227

2025P002034

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 55 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Arm 1 Cataract Surgery performed with remimazolam as sedative

Experimental group

Description:

Subjects are serving as their own control. Subjects are scheduled for cataract surgery in both eyes. Sedation will be remimazolam in one eye and the standard of care in the other eye. The order of sedation will be randomly determined (50% of subjects will have remimazolam in the first eye surgery and 50% will have it in the second eye surgery.) Subjects will be blinded as to which sedation is provided at each surgery.

Treatment:

Drug: Arm 1 Cataract Surgery performed with remimazolam as sedative

Arm 2 Cataract Surgery performed with a standard of care sedative

Placebo Comparator group

Description:

Subjects are serving as their own control. Subjects are scheduled for cataract surgery in both eyes. Sedation in this arm will be the standard of care. The order of sedation will be randomly determined (50% of subjects will have remimazolam in the first eye surgery and 50% will have it in the second eye surgery.) Subjects will be blinded as to which sedation is provided at each surgery.

Treatment:

Drug: Arm 2 Cataract Surgery performed with standard of care sedative