Study of Remimazolam for Cataract Surgery

Conditions

• Cataract Surgery Anesthesia

Eligibility Criteria

Sex

ALL

Age

55 Years - 90 Years

Healthy Volunteers

Accepted

Interventions

• Arm 1 Cataract Surgery performed with remimazolam as sedative — DRUG
  Sedation will be remimazolam in one eye and the standard of care in the other eye.
• Arm 2 Cataract Surgery performed with standard of care sedative — DRUG
  Standard of care sedative will be used during surgery.

Study Details

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.

Key Dates

Start date

Apr 28, 2026

Status verified

Apr 2026

Primary completion

Jan 1, 2028

Completion

Jun 1, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Arms

• Experimental: Arm 1 Cataract Surgery performed with remimazolam as sedative
  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.
• Placebo Comparator: Arm 2 Cataract Surgery performed with a standard of care sedative
  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.

Primary Outcome Measure

The number of sedation-related adverse events [ Time Frame: Subjects consent to participate in study on day of surgery. AE data will be collected during surgery and through the following day when patient is contacted for follow-up. Adverse events will be documented up to one week after surgery should they occur ]

Central Contacts

• Vikranth R. Chinthareddy, BA
  617-573-3380
  [email protected]

Locations (1)

Find similar trials in Boston, MA

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