NCT05980117 · University of California, Los Angeles
Remimazolam for Cataract Surgery
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Remimazolam
Remimazolam (1.0mg IV) titrated to modified observer's assessment of sedation score of 3 -4 during cataract surgery.
DRUG
Midazolam
Midazolam (0.5-2mg IV) titrated to modified observer's assessment of sedation score of 3 - 4 during cataract surgery.
Primary outcome measures
Change in MoCA score following surgery in the PACU and post operative day 1.
Time frame: Immediately following surgery in the PACU and post operative day 1.
Montreal Cognitive Assessment (MoCA) test. A numerical scale is used for scoring. 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment
Change in MoCA Scores in PACU and the next day between midazolam and remimazolam group.
Time frame: Immediately following surgery in the PACU, and post operative day 1.
Montreal Cognitive Assessment (MoCA) test. The following ranges may be used to grade severity: A numerical scale is used for scoring. 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment.
Length of postoperative stay
Time frame: Postop day 0 (day of surgery) until discharge from the hospital, usually on postop day 1 (an average of 1 day).
Duration from the time of admission to readiness for discharge from the PACU. The following ranges may be used to grade severity:
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40.
- Patients with chronic pain on opiates.
- Patients with a history of drug, alcohol abuse/dependence.
- Patients with BMI \> 40.
- Patients with obstructive sleep apnea (moderate to severe).
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 19, 2025 · Source of record for eligibility and locations