Remimazolam for Sedation in Cataract Surgery, A Phase IV, On-label, Blinded Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The number of sedation-related adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Arm 2 Cataract Surgery performed with a standard of care sedative
Subjects are serving as their own control. Subjects are scheduled for cataract surgery in both eyes. Sedation in this arm will be the standard of care. The order of sedation will be randomly determined (50% of subjects will have remimazolam in the first eye surgery and 50% will have it in the second eye surgery.) Subjects will be blinded as to which sedation is provided at each surgery.
干预措施: Arm 2 Cataract Surgery performed with standard of care sedative (Drug)
Arm 1 Cataract Surgery performed with remimazolam as sedative
Subjects are serving as their own control. Subjects are scheduled for cataract surgery in both eyes. Sedation will be remimazolam in one eye and the standard of care in the other eye. The order of sedation will be randomly determined (50% of subjects will have remimazolam in the first eye surgery and 50% will have it in the second eye surgery.) Subjects will be blinded as to which sedation is provided at each surgery.
干预措施: Arm 1 Cataract Surgery performed with remimazolam as sedative (Drug)
结局指标
主要结局
The number of sedation-related adverse events
时间窗: 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.
The severity of sedation-related adverse events
时间窗: 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
The duration of sedation-related adverse events
时间窗: 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
Time that subject remains in the post anesthesia care unit (PACU)
时间窗: 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.
次要结局
- Subjects' scores using the Aldrete Postanesthetic Recovery assessment(During the time subject is in the post anesthesia care unit (PACU))
- Subjects' scores on the Richmond Agitation Sedation Scale (RASS)(During the time subject is in the post anesthesia care unit (PACU))
- Subjects' scores on patient satisfaction questionnaires(Questionnaire will be completed the day after surgery)
研究者
Fred E, Shapiro
Principal Investigator
Massachusetts Eye and Ear Infirmary