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Cataract SurgeryPhase 4NCT05980117

Remimazolam for Cataract Surgery

A Phase 4 study testing Remimazolam and Midazolam in people with Cataract Surgery and Cognitive Impairment, run by University of California, Los Angeles at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Cataract Surgery, Cognitive Impairment
What is being tested?
Remimazolam and Midazolam
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
10 Mar 2025to Jan 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Patients with a history of drug, alcohol abuse/dependence.
  • Patients with BMI > 40.
  • Patients with obstructive sleep apnea (moderate to severe).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhuang T Fang, MD contact

310-267-8946

ZFang@mednet.ucla.edu

Stephanie-Dee Sarovich, BS contact

424-832-6842

ssarovich@mednet.ucla.edu

United States1 site, 1 recruiting

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

    Los Angeles, California, 90095

    Stephanie-Dee Sarovich, B.S., 424-832-6842, ssarovich@mednet.ucla.edu

    Gundappa Neelakanta, M.D.

    Recruiting

Other trials in United States

About this study

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

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).

Read more

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)
Read the detailed 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.

Being tested
Remimazolam, Midazolam
Keywords
Midazolam, Remimazolam, Outcomes
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemimazolamDrug

    Also called Byfavo

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

  • MidazolamDrug

    Also called Versed

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

Study groups in NCT05980117
Study groupRoleWhat they receive
InterventionExperimentalPatients assigned to the study group will receive Remimazolam.
Receives: Drug: Remimazolam
ControlActive comparatorPatients assigned to the control group will receive Midazolam.
Receives: Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Immediately following surgery in the PACU and post operative day 1.

  2. 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.

    Measured: Immediately following surgery in the PACU, and post operative day 1.

  3. 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:

    Measured: Postop day 0 (day of surgery) until discharge from the hospital, usually on postop day 1 (an average of 1 day).

Secondary outcomes (2)

  1. 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.

    Measured: Intraoperatively to postoperatively in the ICU, and expected average of 1 hour.

  2. 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.

    Measured: Day of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2023
  2. Study start10 Mar 2025
  3. Primary completionDec 2025 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized to the intervention group receiving Remimazolam or to the control group receiving Midazolam.
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05980117
Sponsor's protocol ID
22-001570
Status last verified
Mar 2025
First submitted
21 Jun 2023
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rabinowitz LE, Lamper L, Tendler JM, Schlesinger JM, Vera N. Preventing Adverse Events in Cataract Surgery. Anesth Analg. 2018 Oct;127(4):e66. doi: 10.1213/ANE.0000000000003655. No abstract available.

    PubMed 30059403

  • Chung F, Lavelle PA, McDonald S, Chung A, McDonald NJ. Cognitive impairment after neuroleptanalgesia in cataract surgery. Anesth Analg. 1989 May;68(5):614-8.

    PubMed 2719292

  • Evered LA, Silbert BS, Scott DA, Maruff P, Ames D, Choong PF. Preexisting cognitive impairment and mild cognitive impairment in subjects presenting for total hip joint replacement. Anesthesiology. 2011 Jun;114(6):1297-304. doi: 10.1097/ALN.0b013e31821b1aab.

    PubMed 21502855

  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PubMed 15817019

  • Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51.

    PubMed 2286697

  • Tan Y, Ouyang W, Tang Y, Fang N, Fang C, Quan C. Effect of remimazolam tosilate on early cognitive function in elderly patients undergoing upper gastrointestinal endoscopy. J Gastroenterol Hepatol. 2022 Mar;37(3):576-583. doi: 10.1111/jgh.15761. Epub 2022 Jan 3.

    PubMed 34907594

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Remimazolam and Midazolam in people with Cataract Surgery and Cognitive Impairment, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhuang T Fang, MD (310-267-8946, ZFang@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05980117, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.

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