Recruiting

Remimazolam

Sponsor:

UCLA

Code:

NCT05980117

Conditions

Cataract Surgery

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Remimazolam

Midazolam

Study Details

Brief 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

Cataract Surgery

Cognitive Impairment

Study ID

NCT05980117

Start date

Mar 10, 2025

Status verified date

Mar, 2025

Completion date

Jan, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

Patients assigned to the study group will receive Remimazolam.

active comparator: Control

Patients assigned to the control group will receive Midazolam.

Interventions

Remimazolam

Remimazolam (1.0mg IV) titrated to modified observer's assessment of sedation score of 3 -4 during cataract surgery.

Midazolam

Midazolam (0.5-2mg IV) titrated to modified observer's assessment of sedation score of 3 - 4 during cataract surgery.

Primary outcome measure

  • Change in MoCA score following surgery in the PACU and post operative day 1. [ Time Frame: 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. [ Time Frame: Immediately following surgery in the PACU, and post operative day 1. ]
  • Length of postoperative stay [ Time Frame: Postop day 0 (day of surgery) until discharge from the hospital, usually on postop day 1 (an average of 1 day). ]

Central Contacts and Locations

Central contacts

Zhuang T Fang, MD

310-267-8946ZFang@mednet.ucla.edu

Stephanie-Dee Sarovich, BS

424-832-6842ssarovich@mednet.ucla.edu

Locations

Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine

Recruiting

Los Angeles, California, United States, 90095

Contacts

Stephanie-Dee Sarovich, B.S.

424-832-6842ssarovich@mednet.ucla.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Mar 19, 2025

Last verified

Mar, 2025

Keywords

  • Midazolam
  • Remimazolam
  • Outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2025-03-19.