Menu
Not yet recruiting NCT07325227

Study of Remimazolam for Cataract Surgery

Phase IV Interventional Cataract Surgery Anesthesia

For patients and families

In plain language

Fill the application

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Arm 1 Cataract Surgery performed with remimazolam as sedative, Arm 2 Cataract Surgery performed with standard of care sedative.
Who it may be relevant to
Registry conditions: Cataract Surgery Anesthesia. Basic parameters: 55 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Remimazolam for Sedation in Cataract Surgery, A Phase IV, On-label, Blinded Study

Overview

The goal of this clinical trial is to learn if the use of the sedative remimazolam improves the safety of patients having cataract surgery by decreasing the number of sedation-related complications during and after surgery, and shortening post-surgical cognitive recovery time.

Detailed description

Remimazolam (Byfavo) is a novel benzodiazepine approved by the U.S. Food and Drug Administration in July 2020 for sedation in patients undergoing procedures less than 30 minutes in duration. Remimazolam is a rapid onset/offset benzodiazepine, designed to be rapidly metabolized without active metabolites reduce the changes in cognitive function known to occur after even a brief exposure to a sedative. This study will use remimazolam on-label to sedate patients having cataract surgeries that take less than 30 minutes to perform. The investigator is studying the use of remimazolam in cataract surgery because the investigator think it will improve patient safety by shortening post-surgery cognitive recovery time and decreasing the number of sedation-related complications.

Interventions

  • Drug Arm 1 Cataract Surgery performed with remimazolam as sedative
    Sedation will be remimazolam in one eye and the standard of care in the other eye.
  • Drug Arm 2 Cataract Surgery performed with standard of care sedative
    Standard of care sedative will be used during surgery.

Primary outcome measures

  • The number of sedation-related adverse events [Time frame: Subjects consent to participate in study on day of surgery. AE data will be collected during surgery and through the following day when patient is contacted for follow-up. Adverse events will be documented up to one week after surgery should they occur]
  • The severity of sedation-related adverse events [Time frame: Subjects consent to participate in study on day of surgery. AE data will be collected during surgery and through the following day when patient is contacted for follow-up. Adverse events will be documented up to one week after surgery should they occur]
  • The duration of sedation-related adverse events [Time frame: Subjects consent to participate in study on day of surgery. AE data will be collected during surgery and through the following day when patient is contacted for follow-up. Adverse events will be documented up to one week after surgery should they occur]
  • Time that subject remains in the post anesthesia care unit (PACU) [Time frame: Minutes starting with arrival in PACU after surgery until subject meets criteria for discharge]
Secondary outcome measures (3)
  • Subjects' scores using the Aldrete Postanesthetic Recovery assessment [Time frame: During the time subject is in the post anesthesia care unit (PACU)]
  • Subjects' scores on the Richmond Agitation Sedation Scale (RASS) [Time frame: During the time subject is in the post anesthesia care unit (PACU)]
  • Subjects' scores on patient satisfaction questionnaires [Time frame: Questionnaire will be completed the day after surgery]

Eligibility criteria

Inclusion criteria

  • Subject is planning to have cataract surgery in both eyes
  • The surgeon estimates that each cataract surgery are estimated to take less than 30 minutes
  • Subject is aged 55 to 90 years old
  • Surgeries will take place on the main campus of Mass Eye and Ear at 243 Charles St., Boston for at least the first year. In the future, surgeries may also occur at Mass Eye and Ear Longwood Surgical Ambulatory Care Center.
  • Subject is able to understand the consent form and sign the consent
  • ASA 1-3 (possible breakdown numbers of 5, 10, 10, 5)

Exclusion Criteria • Subject does not speak or read English

  • Subject has a history of difficulty with sedation during procedures
  • The surgeon estimates that one of the planned cataract surgeries is estimated to take longer than 30 minutes
  • Subject uses concomitant home narcotic or anxiolytic
  • Subject uses O2
  • Subject has a history of cognitive decline
  • A history of severe hepatic impairment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Massachusetts Eye and Ear Infirmary — Boston

Publications

  • Alqudah A, Al-Dwairi R, Sharayah A, Al-Qudah NS, Almustafa YS, Al-Qudah A, Alharahsheh D, Al Awam RK, Al-Qudah H, Aleshawi A. Second Eye Syndrome: Patients' Perspectives Regarding First Eye versus Second Eye Phacoemulsification and Intraocular Lens Implantation Surgery. Patient Prefer Adherence. 2025 Jul 19;19:2081-2094. doi: 10.2147/PPA.S534166. eCollection 2025. PMID 40704218

Identifiers

NCT: NCT07325227 · 2025P002034

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗