Remimazolam for Cataract Surgery

Study Overview
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Brief Summary
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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: Complete MoCA testing prior to surgery Randomize in either Midazolam or study drug Remimazolam 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. Complete Patient Satisfaction Survey at the time of discharge from the Post Anesthesia Care Unit (PACU)

Detailed Description
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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.

Official Title
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Comparison of Remimazolam vs. Midazolam for Sedation During Cataract Surgery

Conditions
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Cataract Surgery, Cognitive Impairment

Intervention / Treatment
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* Drug: Remimazolam
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to the intervention group receiving Remimazolam or to the control group receiving Midazolam.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients assigned to the study group will receive Remimazolam. | Drug: Remimazolam<br>* Remimazolam (1.0mg IV) titrated to modified observer's assessment of sedation score of 3 -4 during cataract surgery.<br>* Other names: Byfavo;|
| Active Comparator: Control<br>Patients assigned to the control group will receive Midazolam. | Drug: Midazolam<br>* Midazolam (0.5-2mg IV) titrated to modified observer's assessment of sedation score of 3 - 4 during cataract surgery.<br>* Other names: Versed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in MoCA score 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 | Immediately following surgery in the PACU and post operative day 1. | 
| Change in MoCA Scores in PACU and the next day between midazolam and remimazolam group. | 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. | Immediately following surgery in the PACU, and post operative day 1. | 
| Length of postoperative stay | Duration from the time of admission to readiness for discharge from the PACU. The following ranges may be used to grade severity: | Postop day 0 (day of surgery) until discharge from the hospital, usually on postop day 1 (an average of 1 day). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon Satisfaction | 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. | Intraoperatively to postoperatively in the ICU, and expected average of 1 hour. | 
| Patient Satisfaction | 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. | Day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Midazolam, Remimazolam, Outcomes