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Remimazolam for Cataract Surgery

NCT05980117 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-03-19

No results posted yet for this study

Summary

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)

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Zhuang Fang, MD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2025-12-31
Completion
2026-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05980117 on ClinicalTrials.gov