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RECRUITINGPhase 4INTERVENTIONAL

Remimazolam for Cataract Surgery

Comparison of Remimazolam vs. Midazolam for Sedation During Cataract Surgery

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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)

Who May Be Eligible (Plain English)

Who May Qualify: 1. Adult patients age \> 65 years undergoing first eye cataract surgery under local topical anesthesia at the University of California, Los Angeles (UCLA). 2. Both male and female patients 3. American Society of Anesthesiologists Class 2, 3, and 4. Who Should NOT Join This Trial: 1. Patients who are unable to consent for the study 2. Patients who are unable to cooperate with the cognitive assessment such as patients with significant visual, auditory, language or other impairment. 3. Patients who are unable to understand simple English commands. 4. Patients who do not wish to have benzodiazepine medication during surgery 5. Patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40. 6. Patients with chronic pain on opiates. 7. Patients with a history of drug, alcohol abuse/dependence. 8. Patients with BMI \> 40. 9. Patients with obstructive sleep apnea (moderate to severe). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Adult patients age \> 65 years undergoing first eye cataract surgery under local topical anesthesia at the University of California, Los Angeles (UCLA). 2. Both male and female patients 3. American Society of Anesthesiologists Class 2, 3, and 4. Exclusion Criteria: 1. Patients who are unable to consent for the study 2. Patients who are unable to cooperate with the cognitive assessment such as patients with significant visual, auditory, language or other impairment. 3. Patients who are unable to understand simple English commands. 4. Patients who do not wish to have benzodiazepine medication during surgery 5. Patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40. 6. Patients with chronic pain on opiates. 7. Patients with a history of drug, alcohol abuse/dependence. 8. Patients with BMI \> 40. 9. Patients with obstructive sleep apnea (moderate to severe).

Treatments Being Tested

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.

Locations (1)

Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
Los Angeles, California, United States