Study of Remimazolam for Cataract Surgery
ConditionCataract Surgery Anesthesia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age55-90
SponsorFred E, Shapiro
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Arm 1 Cataract Surgery performed with remimazolam as sedative
DrugSedation 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
DrugStandard of care sedative will be used during surgery.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Arm 1 Cataract Surgery performed with remimazolam as sedativeExperimental treatment 1 intervention
Group B: Arm 2 Cataract Surgery performed with a standard of care sedativePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 occur2
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 occur3
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 occur4
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 dischargeSecondary outcomes
1
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)2
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)3
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 surgeryOther outcomes
1
Patients' Indirect costs
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.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fred E, Shapiro
Lead sponsor
Massachusetts Eye and Ear Infirmary
Sponsor institution
Eagle Pharmaceuticals, Inc.
Collaborator
Massachusetts Eye and Ear Infirmary
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: