Study Comparing Remimazolam and Midazolam for Sedation During Cataract Surgery in Older Adults

What this Trial Is About

The trial investigates cognitive changes after cataract surgery in elderly patients aged 65 and older. It compares the effects of two sedative drugs, Midazolam and Remimazolam, on cognitive function following surgery. Researchers aim to assess differences in recovery times and cognitive performance using the Montreal Cognitive Assessment MoCA test, which screens for mild cognitive impairment. This study is conducted as a randomized, phase 4 clinical trial. Participants will be randomly assigned to receive either Remimazolam or Midazolam during their cataract surgery under local topical anesthesia. Remimazolam is given as a 1.0mg intravenous dose, while Midazolam doses range from 0.5 to 2mg intravenously, both adjusted to a sedation score between 3 and 4. The study measures cognitive function before surgery, immediately after surgery in the post anesthesia care unit PACU, and the day after surgery during a post-operative visit. Patients will also complete a satisfaction survey about their anesthesia experience at discharge from PACU. Throughout the study, participants undergo MoCA testing at three time points to monitor cognitive changes before surgery, at PACU discharge, and on the first post-operative day. Researchers will also track the length of post-operative hospital stay and assess surgeon and patient satisfaction with anesthesia. The total participation lasts from the day of surgery until the post-operative visit the next day, with careful monitoring of recovery and cognitive outcomes.

Remimazolam for Cataract Surgery