Remimazolam for Cataract Surgery

NCT05980117 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 22-001570
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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. 1.Complete MoCA testing prior to surgery
2. 2.Randomize in either Midazolam or study drug Remimazolam
3. 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. 4.Complete Patient Satisfaction Survey at the time of discharge from the Post Anesthesia Care Unit (PACU)

Conditions

Cataract Surgery; Cognitive Impairment

Keywords

Midazolam; Remimazolam; Outcomes

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

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

• 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:

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

Secondary Outcomes (2)

• Surgeon Satisfaction

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

• Patient Satisfaction

  Day of surgery

Study Arms (2)

Intervention

EXPERIMENTAL

Patients assigned to the study group will receive Remimazolam.

Drug: Remimazolam

Control

ACTIVE COMPARATOR

Patients assigned to the control group will receive Midazolam.

Drug: Midazolam

Interventions

Remimazolam DRUG

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

Also known as: Byfavo

Intervention

Midazolam DRUG

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

Also known as: Versed

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

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

Los Angeles, California, 90095, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 30059403 BACKGROUND

• 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.

  PMID: 2719292 BACKGROUND

• 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.

  PMID: 21502855 BACKGROUND

• 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.

  PMID: 15817019 BACKGROUND

• 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.

  PMID: 2286697 BACKGROUND

• 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.

  PMID: 34907594 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

remimazolam; Midazolam

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Zhuang Fang, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuang T Fang, MD

CONTACT

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

Stephanie-Dee Sarovich, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomized to the intervention group receiving Remimazolam or to the control group receiving Midazolam.

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: August 7, 2023
• Study Start: March 10, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)