What side effects are associated with this type of intervention?

Common treatments for cognitive impairment that enhance GABA-A receptor activity, such as Midazolam and Remimazolam, are associated with several side effects. These include sedation, dizziness, and cognitive impairment, which can manifest as confusion or memory issues. Additionally, there is a risk of dependence and withdrawal symptoms with prolonged use. Specific to Midazolam, side effects may also include respiratory depression and hypotension. Remimazolam, with its shorter duration of action, may have a reduced risk of prolonged sedation and cognitive impairment post-procedure.

What prior FDA approvals exist?

FDA-approved treatments for cognitive impairment have included drugs that enhance GABA-A receptor activity, such as benzodiazepines like Midazolam. These drugs are known for their sedative and anxiolytic effects, which can indirectly benefit cognitive function by reducing anxiety and improving sleep. Remimazolam, a newer agent with a shorter duration of action, is being studied for its potential cognitive benefits post-surgery. Additionally, other treatments for cognitive impairment, particularly in Alzheimer's disease, include cholinesterase inhibitors (e.g., Donepezil) and NMDA receptor antagonists (e.g., Memantine), which aim to improve neurotransmitter function and protect against neurodegeneration.

What other types of research exist?

Promising alternatives to Midazolam and Remimazolam for cognitive impairment patients include: <ol> <li>Dexmedetomidine - An alpha-2 adrenergic agonist with sedative properties that has minimal impact on cognitive function.</li> <li>Propofol - A short-acting sedative-hypnotic agent that can be used for procedural sedation with rapid recovery and minimal cognitive side effects.</li> <li>Ketamine - An NMDA receptor antagonist that provides sedation and analgesia with a different mechanism of action, potentially reducing cognitive side effects.</li> <li>Suvorexant - An orexin receptor antagonist that promotes sleep without significant cognitive impairment, useful for managing sleep disturbances in cognitive impairment patients.</li> </ol>

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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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two anxiety-reducing medications, Midazolam and Remimazolam, in elderly patients having cataract surgery. The goal is to see if Remimazolam causes fewer cognitive side effects compared to Midazolam. Patients will take a cognitive test to measure any changes. Remimazolam is a newly developed medication with quicker effects than Midazolam.

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.

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.

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 ~ day of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Patient Satisfaction

Surgeon Satisfaction

Side effects data

From 2016 Phase 3 trial • 461 Patients • NCT02290873

39%

Hypotension

20%

Hypertension

11%

Bradycardia

10%

Diastolic Hypertension

Tachycardia

Diastolic Hypotension

Systolic hypertension

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Remimazolam

Placebo

Midazolam

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~2870

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cognitive impairment, such as Midazolam and Remimazolam, work by enhancing the activity of the GABA-A receptor, which increases inhibitory effects in the brain. This mechanism can help manage symptoms like anxiety and agitation in cognitive impairment patients. Remimazolam, with its shorter duration of action, may provide advantages in terms of fewer side effects and faster recovery compared to longer-acting benzodiazepines.

Factors contributing to the decay of the stimulus-evoked IPSC in rat hippocampal CA1 neurons.Behavioral and biochemical characterization of benzodiazepine receptor partial agonists in pigeons.Allopregnanolone and perampanel as adjuncts to midazolam for treating diisopropylfluorophosphate-induced status epilepticus in rats.