Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
Los Angeles, California, 90095, United States
Location status: Recruiting
NCT Number: NCT05980117
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)
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Phase 4
Los Angeles, California, 90095, United States
Location status: Recruiting
Cataract surgery (clouded natural lens of eye removed and clear artificial lens implanted) is the most common eye surgery performed in elderly patients. Although cataract surgery is a minor surgery, many patients are anxious and therefore benzodiazepine such as midazolam is administered during surgery to allay a patient's anxiety.
The purpose of this study is to look at any difference in postoperative cognitive changes as well as recovery times in the PACU following administration of midazolam or remimazolam.
Patients will be asked to participate in a clinical trial where they will be randomly assigned to midazolam or remimazolam group. Cognitive changes will be assessed by administration of MoCA test. MoCA test is a validated, objective short (about 10-15 minutes) screening tool for detection of mild neurocognitive dysfunction. Given the short half life of remimazolam, investigators hypothesize that any cognitive changes will be less with remimazolam compared to midazolam.
Patients will be asked to complete MoCA prior to surgery, in the recovery room following surgery, and the next day during their post-operative clinic visit. In addition, patients will be asked to rate their satisfaction of their anesthetic during their surgery.
The participant will be in this research study from the day of surgery until the first post-operative visit, the following day.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Remimazolam (1.0mg IV) titrated to modified observer's assessment of sedation score of 3 -4 during cataract surgery.
Other names: Byfavo
Midazolam (0.5-2mg IV) titrated to modified observer's assessment of sedation score of 3 - 4 during cataract surgery.
Other names: Versed
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
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.
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:
Time frame: Intraoperatively to postoperatively in the ICU, and expected average of 1 hour.
Surgeon satisfaction score will be assessed post-surgery as measured by a 5-point scale with 1 = Strongly Disagree , 2 = Disagree , 3 = Neither Agree nor Disagree, 4 = Agree, 5 = Strongly Agree.
Time frame: Day of surgery
Patient satisfaction score will be assessed at the time of discharge by a 5 point scale with 1 = Disagree Strongly , 2 = Disagree Somewhat , 3 = Neither Agree or Disagree, 4 = Agree Somewhat, 5 = Agree Strongly.
Interested in participating?
Request InfoUniversity of California, Los Angeles
Other
Comparison of Remimazolam vs. Midazolam for Sedation During Cataract Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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