Remimazolam for Cataract Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of California, Los Angeles
About this trial
The goal of this study is to assess any post operative cognitive changes following benzodiazepine administration during cataract surgery. The investigators will compare effects of Midazolam vs. Remimazolam on cognition at the time of discharge from the post operative care unit and the next day following surgery.
Cognitive changes will be assessed by administration of Montreal Cognitive Assessment (MoCA).
Participants will:
1. Complete MoCA testing prior to surgery 2. Randomize in either Midazolam or study drug Remimazolam 3. Complete MoCA testing after surgery at the time of discharge in the post anesthesia care unit and the next day of surgery at the time of post operative surgical visit. 4. Complete Patient Satisfaction Survey at the time of discharge from the Post Anesthesia Care Unit (PACU)
Eligibility criteria
Qualifiers
Adult patients age > 65 years undergoing first eye cataract surgery under local topical anesthesia at the University of California, Los Angeles (UCLA).
Both male and female patients
American Society of Anesthesiologists Class 2, 3, and 4.
Disqualifiers
Patients who are unable to consent for the study
Patients who are unable to cooperate with the cognitive assessment such as patients with significant visual, auditory, language or other impairment.
Patients who are unable to understand simple English commands.
Patients who do not wish to have benzodiazepine medication during surgery
Trial design
Treatments tested in this trial
- Remimazolam
- Midazolam
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov