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Remimazolam vs Midazolam for Cataract
Phase 4
Waitlist Available
Led By Zhuang Fang, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postop day 0 (day of surgery) until discharge from the hospital, usually on postop day 1 (an average of 1 day).
Awards & highlights
Study Summary
This trial will compare the effects of Midazolam and Remimazolam on cognition after cataract surgery using a MoCA test and Patient Satisfaction survey.
Who is the study for?
This trial is for adults over 65 who are having their first cataract surgery at UCLA and can follow simple English commands. They should be in stable health but not severely overweight, have sleep apnea, chronic pain on opiates, or a history of certain allergies or substance abuse.Check my eligibility
What is being tested?
The study compares the effects of two sedatives—Midazolam and Remimazolam—on patients' cognitive function after cataract surgery. Cognitive changes are measured using the MoCA test before surgery, upon discharge from post-op care, and the following day.See study design
What are the potential side effects?
Potential side effects may include drowsiness, confusion, impaired coordination, memory problems immediately after waking up from anesthesia. These drugs could also cause allergic reactions or interact with other medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately following surgery in the pacu and post operative day 1.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following surgery in the pacu and post operative day 1.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in MoCA Scores in PACU and the next day between midazolam and remimazolam group.
Change in MoCA score following surgery in the PACU and post operative day 1.
Length of postoperative stay
Secondary outcome measures
Patient Satisfaction
Surgeon Satisfaction
Side effects data
From 2016 Phase 3 trial • 461 Patients • NCT0229087339%
Hypotension
20%
Hypertension
11%
Bradycardia
10%
Diastolic Hypertension
8%
Tachycardia
8%
Diastolic Hypotension
5%
Systolic hypertension
2%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Remimazolam
Placebo
Midazolam
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Patients assigned to the study group will receive Remimazolam.
Group II: ControlActive Control1 Intervention
Patients assigned to the control group will receive Midazolam.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remimazolam
2022
Completed Phase 4
~2850
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,528 Previous Clinical Trials
10,276,731 Total Patients Enrolled
Zhuang Fang, MDPrincipal InvestigatorUniversity of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 65 and having my first cataract surgery at UCLA.I have moderate to severe obstructive sleep apnea.I am either male or female.My BMI is over 40.I am unable to give consent for the study myself.I am unable to participate in cognitive tests due to a significant impairment.I prefer not to receive benzodiazepine medication during surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Intervention protocol been greenlighted by the FDA?
"Due to its Phase 4 status, the safety of this intervention was assessed as a 3 according to our team at Power. This indicates that it has already been approved for use in patients."
Answered by AI
Is enrollment open for the current clinical trial?
"Unfortunately, according to current information on clinicaltrials.gov this trial is not actively enrolling participants anymore; it was first posted in September of 2023 and had its last update done in August of the same year. Although recruitment has ended for this study, 271 other trials are presently searching for appropriate candidates."
Answered by AI
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