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NCT Number: NCT07325227

Study of Remimazolam for Cataract Surgery

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.

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Key information

Conditions

Cataract Surgery Anesthesia

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location contact

Fred E. Shapiro, DO, FASA

PRINCIPAL_INVESTIGATOR

Vikranth R. Chinthareddy, BA

CONTACT

[email protected]

617-573-3380

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm 1 Cataract Surgery performed with remimazolam as sedative

Drug

Sedation will be remimazolam in one eye and the standard of care in the other eye.

Arm 2 Cataract Surgery performed with standard of care sedative

Drug

Standard of care sedative will be used during surgery.

Primary outcomes

  1. 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 number of sedation-related adverse events from the time sedation is administered at the start of surgery through up to one week post-surgery.

  2. 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 severity (mild, moderate or severe) of sedation-related adverse events

  3. 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

    The duration, in minutes, hours, or days of sedation-related adverse events

  4. 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

    Length of time in minutes that subject remains in the post anesthesia care unit (PACU) until he or she meets criteria for discharge. We are recruiting subjects whose cataract surgery is deemed uncomplicated and anticipated to last no more than 30 minutes. This is required to use remimazolam on label. We anticipate that subjects would be in the PACU for less than sixty minutes, but that the use of remimazolam will lead to discharge in less than 30 minutes.

Secondary outcomes

  1. 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 repeated assessments made by staff while they are in the PACU using the Aldrete Postanesthetic Recovery Score system.

    The Aldrete Scoring System consists of 5 clinically relevant parameters reflecting physiological recovery from anesthesia: muscle activity, respiration, circulation, consciousness, and oxygenation. Each category is assigned a score of 0, 1, or 2, with a maximum possible total score of 10.

  2. 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 repeated assessments made by staff while they are in the PACU using the Richmond Agitation Sedation Scale (RASS).

    The Richmond Agitation Sedation Scale (RASS) was developed to assess the level of alertness and agitated behavior in patients who have received sedation. It is a 10-point scale ranging from -5 to +4. Levels -1 to -5 denote 5 levels of sedation and levels +1 to +4 describe increasing levels of agitation.

  3. Subjects' scores on patient satisfaction questionnaires

    Time frame: Questionnaire will be completed the day after surgery

    Subjects will be asked to complete a questionnaire regarding their satisfaction with the sedation they received and their post-surgical recovery

Other outcomes

  1. Patients' Indirect costs

    Time frame: 1 year

    We aim to compare subjects' indirect costs associated with post-surgical care i.e. time spent in the PACU prior to discharge post-surgery, and the time clinicians spend providing follow-up care related to the surgery in the weeks following discharge. We would like to compare standard of care vs. remimazolam.

Study contacts

Contact information is provided by the study sponsor or research team.

Vikranth R. Chinthareddy, BA

CONTACT

[email protected]

617-573-3380

Sponsors and collaborators

Lead sponsor

Fred E, Shapiro

Other

Collaborators

  • Eagle Pharmaceuticals, Inc.
  • Massachusetts Eye and Ear Infirmary

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 8, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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