What side effects are associated with this type of intervention?

Common treatments for neuromuscular blockade include aminosteroid NMBAs such as rocuronium and vecuronium. Sugammadex is used to reverse the effects of these NMBAs by encapsulating them. Known side effects of these treatments can include bradycardia, hypotension, and residual neuromuscular blockade. Sugammadex itself is generally well-tolerated but can cause hypersensitivity reactions, including anaphylaxis, and transient increases in coagulation parameters.

What prior FDA approvals exist?

Sugammadex is an FDA-approved drug specifically designed to reverse neuromuscular blockade induced by aminosteroid NMBAs such as rocuronium and vecuronium. Unlike traditional anticholinesterases like neostigmine, which increase acetylcholine levels to counteract the blockade, Sugammadex works by encapsulating the NMBAs, thereby rapidly reversing their effects. This mechanism provides a more efficient and targeted approach to managing neuromuscular blockade in surgical settings.

What other types of research exist?

As of 2024, promising novel alternatives to Sugammadex for neuromuscular blockade patients include Calabadion and Bridion. Calabadion is a synthetic molecular container that can encapsulate a variety of NMBAs, including both aminosteroid and benzylisoquinolinium compounds, offering a broader spectrum of action. Bridion, while similar to Sugammadex, has been optimized for faster onset and greater efficacy in reversing deep neuromuscular blockade. Both alternatives are currently under investigation and show potential for improved patient outcomes in clinical settings.

← Back to Search

Sugammadex for Neuromuscular Blockade

Phase 4

Waitlist Available

Led By Rebecca Wong, MBBS, MPH

Research Sponsored by Emory University

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 1 minute, 2 minutes and 10 minutes post administration of study drug

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial tests different doses of sugammadex to see how quickly it can help patients recover muscle function after surgery. The study involves adult patients and measures how fast they regain muscle function.

Who is the study for?

This trial is for adults over 18 who need elective surgery at Grady Memorial Hospital, will receive general anesthesia and a muscle relaxant called rocuronium, and have partially responded to neostigmine as a reversal agent. Excluded are pregnant or breastfeeding individuals, those with severe kidney or liver issues, high BMI (≥40), cognitive impairments, neuromuscular diseases, anticipated post-op intubation needs, or allergies to the drugs involved.

What is being tested?

The study tests five different doses of sugammadex as rescue therapy after inadequate reversal of muscle relaxation from neostigmine. It's a double-blind trial where patients randomly get either sugammadex or placebo without knowing which one they're receiving.

What are the potential side effects?

Sugammadex may cause side effects like allergic reactions, changes in heart rate or blood pressure, headache, nausea and possible complications related to rapid return of muscle strength.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 minute, 2 minutes and 10 minutes post administration of study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 minute, 2 minutes and 10 minutes post administration of study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 minute, 2 minutes and 10 minutes post administration of study drug for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The time taken to achieve a TOF ratio of 0.9 after administration sugammadex

Secondary study objectives

The percentage of patients who achieve a TOF ratio of 0.9

Awards & Highlights

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.

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Sugammadex 1 mg/kgExperimental Treatment1 Intervention

The study team will identify patients who are scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB and neostigmine for NMB reversal. Patients will be randomized using the Emory University REDCap (Research Electronic Data Capture) software to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. The TOF ratio would be measured again at 30 minutes after arrival at the PACU to exclude delayed residual NMB with the plan to give further 2 mg/kg doses of sugammadex if detected.

Group II: Sugammadex 0.5 mg/kgExperimental Treatment1 Intervention

Group III: Sugammadex 0.25 mg/kgExperimental Treatment1 Intervention

Group IV: Sugammadex 0.125 mg/kgExperimental Treatment1 Intervention

Group V: Sugammadex 2 mg/kgActive Control1 Intervention

Group VI: PlaceboPlacebo Group1 Intervention

The inclusion of a placebo group would allow the study team to examine if patients may recover spontaneously over that time without needing any sugammadex at all, and what parameters may predict that subset of patients. It will also improve the dose response modelling, in that randomization has been weighted so that patients who are least likely to need sugammadex (i.e. if they achieved a TOF count of 4 twitches without fade) are more likely to be in the placebo group or at the lowest dose of sugammadex that is being tested.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sugammadex

2017

Completed Phase 4

~3410

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

The most common treatments for Neuromuscular Blockade (NMB) include anticholinesterases like neostigmine and encapsulating agents like Sugammadex. Neostigmine works by increasing acetylcholine levels at the neuromuscular junction, which competes with the NMBAs to restore muscle function. Sugammadex, on the other hand, encapsulates aminosteroid NMBAs such as rocuronium and vecuronium, forming a complex that is then excreted from the body. This encapsulation mechanism allows for a rapid and effective reversal of NMB, which is particularly important for patients to minimize the risk of residual paralysis and associated complications post-surgery.