Remimazolam for Cataract Surgery

University of California, Los Angeles (UCLA)

Status and phase: Enrolling; Phase 4

Conditions: Cognitive Impairment; Cataract Surgery

Treatments: Drug: Remimazolam; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05980117

22-001570

Details and patient eligibility

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.

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)

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Intervention

Experimental group

Description:

Patients assigned to the study group will receive Remimazolam.

Treatment:

Drug: Remimazolam

Control

Active Comparator group

Description:

Patients assigned to the control group will receive Midazolam.

Treatment:

Drug: Midazolam