Study of Remimazolam for Cataract Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат Arm 2 Cataract Surgery performed with standard of care sedative
  Standard of care sedative will be used during surgery.

Первичные конечные точки

• The number of sedation-related adverse events [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Minutes starting with arrival in PACU after surgery until subject meets criteria for discharge]

Вторичные конечные точки (3)

• Subjects' scores using the Aldrete Postanesthetic Recovery assessment [Срок оценки: During the time subject is in the post anesthesia care unit (PACU)]
• Subjects' scores on the Richmond Agitation Sedation Scale (RASS) [Срок оценки: During the time subject is in the post anesthesia care unit (PACU)]
• Subjects' scores on patient satisfaction questionnaires [Срок оценки: Questionnaire will be completed the day after surgery]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Massachusetts Eye and Ear Infirmary — Boston

Публикации

• 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

Идентификаторы

NCT: NCT07325227 · 2025P002034

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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