Preventing Adverse Events in Cataract Surgery.
Lawrence E Rabinowitz, Leonid Lamper, Jay M Tendler...
https://pubmed.ncbi.nlm.nih.gov/30059403Actively Recruiting
Phase 4
Age: 65Years +
All Genders
ID05980117
Comparison of Remimazolam vs. Midazolam for Sedation During Cataract Surgery
Led by University of California, Los Angeles · Updated on 2025-03-19
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Remimazolam for Cataract Surgery
Who Can Participate
Age: 65Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients age over 65 years undergoing first eye cataract surgery under local topical anesthesia at UCLA
- Both male and female patients
- American Society of Anesthesiologists Class 2, 3, and 4
You will not qualify if you...
- Unable to consent for the study
- Unable to cooperate with cognitive assessment due to significant visual, auditory, language, or other impairments
- Unable to understand simple English commands
- Decline benzodiazepine medication during surgery
- History of severe hypersensitivity to dextran 40 or products containing dextran 40
- Chronic pain treated with opiates
- History of drug or alcohol abuse or dependence
- Body mass index over 40
- Moderate to severe obstructive sleep apnea
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - Day of surgery
Participants receive sedation with either Remimazolam or Midazolam during their cataract surgery under local topical anesthesia.
1 surgery visit (in-person)
Post-operative Follow-up
Duration - Until post-operative day 1
Participants complete cognitive assessments and satisfaction ratings in the recovery room after surgery and during a follow-up visit the next day.
2 visits (1 in recovery room and 1 post-operative clinic visit)
Trial Site Locations
Total: 1 location
1
Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
Los Angeles, California, United States, 90095
Actively Recruiting
Loading map...
Research Team
Z
Zhuang T Fang, MD
S
Stephanie-Dee Sarovich, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Cognitive impairment after neuroleptanalgesia in cataract surgery.
F Chung, P A Lavelle, S McDonald...
https://pubmed.ncbi.nlm.nih.gov/2719292Preexisting cognitive impairment and mild cognitive impairment in subjects presenting for total hip joint replacement.
Lisbeth A Evered, Brendan S Silbert, David A Scott...
https://pubmed.ncbi.nlm.nih.gov/21502855The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment.
Ziad S Nasreddine, Natalie A Phillips, Valérie Bédirian...
https://pubmed.ncbi.nlm.nih.gov/15817019Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam.
D A Chernik, D Gillings, H Laine...
https://pubmed.ncbi.nlm.nih.gov/2286697Effect of remimazolam tosilate on early cognitive function in elderly patients undergoing upper gastrointestinal endoscopy.
Yingjie Tan, Wen Ouyang, Yongzhong Tang...
https://pubmed.ncbi.nlm.nih.gov/34907594