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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
30
Sedation will be remimazolam in one eye and the standard of care in the other eye.
Standard of care sedative will be used during surgery.
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
The number of sedation-related adverse events
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.
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
The severity (mild, moderate or severe) 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
The duration, in minutes, hours, or days 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)
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.
Time frame: Minutes starting with arrival in PACU after surgery until subject meets criteria for discharge
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Subjects' scores using the Aldrete Postanesthetic Recovery assessment
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.
Time frame: During the time subject is in the post anesthesia care unit (PACU)
Subjects' scores on the Richmond Agitation Sedation Scale (RASS)
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.
Time frame: During the time subject is in the post anesthesia care unit (PACU)
Subjects' scores on patient satisfaction questionnaires
Subjects will be asked to complete a questionnaire regarding their satisfaction with the sedation they received and their post-surgical recovery
Time frame: Questionnaire will be completed the day after surgery