Remimazolam for Cataract Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of California, Los Angeles
About this trial
The goal of this study is to assess any post operative cognitive changes following benzodiazepine administration during cataract surgery. The investigators will compare effects of Midazolam vs. Remimazolam on cognition at the time of discharge from the post operative care unit and the next day following surgery.
Cognitive changes will be assessed by administration of Montreal Cognitive Assessment (MoCA).
Participants will:
1. Complete MoCA testing prior to surgery 2. Randomize in either Midazolam or study drug Remimazolam 3. Complete MoCA testing after surgery at the time of discharge in the post anesthesia care unit and the next day of surgery at the time of post operative surgical visit. 4. Complete Patient Satisfaction Survey at the time of discharge from the Post Anesthesia Care Unit (PACU)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients age > 65 years undergoing first eye cataract surgery under local topical anesthesia at the University of California, Los Angeles (UCLA).
Both male and female patients
American Society of Anesthesiologists Class 2, 3, and 4.
Disqualifiers
Patients who are unable to consent for the study
Patients who are unable to cooperate with the cognitive assessment such as patients with significant visual, auditory, language or other impairment.
Patients who are unable to understand simple English commands.
Patients who do not wish to have benzodiazepine medication during surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Remimazolam
DrugRemimazolam (1.0mg IV) titrated to modified observer's assessment of sedation score of 3 -4 during cataract surgery.
Midazolam
DrugMidazolam (0.5-2mg IV) titrated to modified observer's assessment of sedation score of 3 - 4 during cataract surgery.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in MoCA score following surgery in the PACU and post operative day 1.
Montreal Cognitive Assessment (MoCA) test. A numerical scale is used for scoring. 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment
Time frame
Immediately following surgery in the PACU and post operative day 1.2
Change in MoCA Scores in PACU and the next day between midazolam and remimazolam group.
Montreal Cognitive Assessment (MoCA) test. The following ranges may be used to grade severity: A numerical scale is used for scoring. 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment.
Time frame
Immediately following surgery in the PACU, and post operative day 1.3
Length of postoperative stay
Duration from the time of admission to readiness for discharge from the PACU. The following ranges may be used to grade severity:
Time frame
Postop day 0 (day of surgery) until discharge from the hospital, usually on postop day 1 (an average of 1 day).Secondary outcomes
1
Surgeon Satisfaction
Surgeon satisfaction score will be assessed post-surgery as measured by a 5-point scale with 1 = Strongly Disagree , 2 = Disagree , 3 = Neither Agree nor Disagree, 4 = Agree, 5 = Strongly Agree.
Time frame
Intraoperatively to postoperatively in the ICU, and expected average of 1 hour.2
Patient Satisfaction
Patient satisfaction score will be assessed at the time of discharge by a 5 point scale with 1 = Disagree Strongly , 2 = Disagree Somewhat , 3 = Neither Agree or Disagree, 4 = Agree Somewhat, 5 = Agree Strongly.
Time frame
Day of surgerySponsors and contacts
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Source ClinicalTrials.gov