What is the mechanism of action of this treatment?

Sugammadex and Neostigmine are common treatments for reversing neuromuscular blockade. Sugammadex encapsulates and inactivates neuromuscular blocking agents like rocuronium and vecuronium, allowing for rapid reversal. Neostigmine inhibits acetylcholinesterase, increasing acetylcholine levels to outcompete the blocking agents at the neuromuscular junction. These mechanisms are important for ensuring effective and timely recovery of muscle function in patients.

What side effects are associated with this type of intervention?

Sugammadex is generally well-tolerated but can cause side effects such as bradycardia, hypotension, and hypersensitivity reactions, including anaphylaxis. Neostigmine, on the other hand, can cause side effects like bradycardia, nausea, vomiting, increased salivation, and muscle cramps. Both drugs require careful monitoring to manage these potential adverse effects effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of neuromuscular blockade, focusing on two primary mechanisms: encapsulation of neuromuscular blocking agents and acetylcholinesterase inhibition. Sugammadex, approved for its ability to encapsulate and reverse the effects of rocuronium and vecuronium, offers rapid recovery from neuromuscular blockade. Neostigmine, an acetylcholinesterase inhibitor, increases acetylcholine levels to counteract the blockade, and is often used in combination with glycopyrrolate to mitigate side effects. These drugs provide effective options for reversing neuromuscular blockade in surgical settings.

What other types of research exist?

As of 2024, promising novel alternatives to Sugammadex and Neostigmine for the reversal of neuromuscular blockade include Calabadion and cysteine-based agents. Calabadion is a synthetic molecular container that encapsulates a wide range of neuromuscular blocking agents, similar to Sugammadex but with potentially broader applicability. Cysteine-based agents work by directly binding to and inactivating certain neuromuscular blocking agents, offering a different mechanism of action compared to traditional acetylcholinesterase inhibitors.

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Cholinesterase Inhibitor

Reversal Agents for Postoperative Urinary Retention

Phase 4

Recruiting

Led By Kurt Ruetzler, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end surgery to discharge

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares two drugs, sugammadex and neostigmine, to help adults recover from muscle relaxation after non-cardiac surgery. Sugammadex works by neutralizing the muscle relaxants directly, while neostigmine helps increase a natural substance in the body. The goal is to find out which drug is more effective.

Who is the study for?

This trial is for adults aged 65 or older who are having noncardiac surgery under general anesthesia with muscle relaxation, and will stay in the hospital overnight. They must be healthy enough (ASA status 1-3) and able to consent. People with urinary issues, severe liver or kidney disease, neurological conditions, or those on certain medications can't join.

What is being tested?

The study compares two drugs used to reverse muscle relaxation after surgery: Sugammadex and Neostigmine combined with glycopyrrolate. It's a randomized trial for patients given rocuronium or vecuronium during their procedure.

What are the potential side effects?

Possible side effects include allergic reactions, changes in heart rate or blood pressure from Neostigmine/glycopyrrolate; Sugammadex may cause minor symptoms like nausea or headache but also has potential for serious allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 hour after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 hour after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour after 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

Urinary Retention

Secondary study objectives

Complications related to urinary retention

Other study objectives

Post -void urine

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

Active Control

Group I: NeostigmineActive Control1 Intervention

Reversal of Neuromuscular Block by Neostigmine.

Group II: SugammadexActive Control1 Intervention

Reversal of Neuromuscular Block by Sugammadex.

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

Sugammadex and Neostigmine are common treatments for reversing neuromuscular blockade. Sugammadex encapsulates and inactivates neuromuscular blocking agents like rocuronium and vecuronium, allowing for rapid reversal. Neostigmine inhibits acetylcholinesterase, increasing acetylcholine levels to outcompete the blocking agents at the neuromuscular junction. These mechanisms are important for ensuring effective and timely recovery of muscle function in patients.