Study of Remimazolam for Cataract Surgery
ConditionCataract Surgery Anesthesia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age55-90
SponsorFred E, Shapiro
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Arm 1 Cataract Surgery performed with remimazolam as sedative
- Arm 2 Cataract Surgery performed with standard of care sedative
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fred E, Shapiro
Lead sponsor
Massachusetts Eye and Ear Infirmary
Sponsor institution
Eagle Pharmaceuticals, Inc.
Collaborator
Massachusetts Eye and Ear Infirmary
Collaborator
Source ClinicalTrials.gov